Study to Assess the Effect of Cannabidiol on Liver Fat Levels in Subjects With Fatty Liver Disease.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GW Research Ltd
ClinicalTrials.gov Identifier:
NCT01284634
First received: January 26, 2011
Last updated: September 9, 2014
Last verified: September 2014
Results First Received: December 3, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Fatty Liver
Intervention: Drug: Cannabidiol

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
200 mg GWP42003 Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
400 mg GWP42003 Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
800 mg GWP42003 Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
Placebo Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.

Participant Flow:   Overall Study
    200 mg GWP42003     400 mg GWP42003     800 mg GWP42003     Placebo  
STARTED     7     6     7     5  
COMPLETED     6     6     5     4  
NOT COMPLETED     1     0     2     1  
Adverse Event                 1                 0                 2                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
200 mg GWP42003 Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first 30 minutes before breakfast [fasted] and the second 30 minutes for the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003 per day.
400 mg GWP42003 Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes for the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003 per day.
800 mg GWP42003 Subjects self-administered four x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes for the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003 per day.
Placebo Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
Total Total of all reporting groups

Baseline Measures
    200 mg GWP42003     400 mg GWP42003     800 mg GWP42003     Placebo     Total  
Number of Participants  
[units: participants]
  7     6     7     5     25  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     6     6     7     5     24  
>=65 years     1     0     0     0     1  
Age  
[units: years]
Mean ± Standard Deviation
  40.69  ± 14.62     49.08  ± 7.72     46.90  ± 12.57     50.41  ± 18.41     46.39  ± 13.29  
Gender  
[units: participants]
         
Female     5     2     2     4     13  
Male     2     4     5     1     12  
Region of Enrollment  
[units: participants]
         
United Kingdom     7     6     7     5     25  



  Outcome Measures
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1.  Primary:   Change From Baseline to the End of Treatment in Mean % Liver Triglyceride Levels   [ Time Frame: After 56 days of treatment ]

Measure Type Primary
Measure Title Change From Baseline to the End of Treatment in Mean % Liver Triglyceride Levels
Measure Description Liver triglyceride levels (%) were measured by MRI/MRS scanning and the change from baseline to end of treatment in group mean levels were investigated. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.
Time Frame After 56 days of treatment  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.

Reporting Groups
  Description
200 mg GWP42003 Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
400 mg GWP42003 Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
800 mg GWP42003 Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
Placebo Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.

Measured Values
    200 mg GWP42003     400 mg GWP42003     800 mg GWP42003     Placebo  
Number of Participants Analyzed  
[units: participants]
  7     6     6     5  
Change From Baseline to the End of Treatment in Mean % Liver Triglyceride Levels  
[units: percentage of liver triglycerides]
Mean ± Standard Deviation
  -0.68  ± 4.97     -0.28  ± 8.60     0.65  ± 5.28     6.36  ± 17.97  


Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean % Liver Triglyceride Levels
Groups [1] 200 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.222
Mean Difference (Final Values) [4] -6.89
Standard Error of the mean ± 5.454
90% Confidence Interval ( -16.35 to 2.56 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment liver triglyceride levels were analysed using a linear regression model, with end of treatment liver triglyceride levels as the dependent variable, dose of GWP42003 as regressor, baseline liver triglyceride levels as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean % Liver Triglyceride Levels
Groups [1] 400 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.133
Mean Difference (Final Values) [4] -9.35
Standard Error of the mean ± 5.943
90% Confidence Interval ( -19.66 to 0.95 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment liver triglyceride levels were analysed using a linear regression model, with end of treatment liver triglyceride levels as the dependent variable, dose of GWP42003 as regressor, baseline liver triglyceride levels as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean % Liver Triglyceride Levels
Groups [1] 800 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.302
Mean Difference (Final Values) [4] -6.54
Standard Error of the mean ± 6.158
90% Confidence Interval ( -17.22 to 4.14 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment liver triglyceride levels were analysed using a linear regression model, with end of treatment liver triglyceride levels as the dependent variable, dose of GWP42003 as regressor, baseline liver triglyceride levels as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



2.  Secondary:   Change From Baseline to the End of Treatment it Mean Serum Total Cholesterol Levels   [ Time Frame: After 56 days of treatment ]

Measure Type Secondary
Measure Title Change From Baseline to the End of Treatment it Mean Serum Total Cholesterol Levels
Measure Description A fasting blood sample was taken for the measurement of serum total cholesterol. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.
Time Frame After 56 days of treatment  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.

Reporting Groups
  Description
200 mg GWP42003 Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
400 mg GWP42003 Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
800 mg GWP42003 Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003 .
Placebo Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.

Measured Values
    200 mg GWP42003     400 mg GWP42003     800 mg GWP42003     Placebo  
Number of Participants Analyzed  
[units: participants]
  7     6     7     5  
Change From Baseline to the End of Treatment it Mean Serum Total Cholesterol Levels  
[units: mmol/l]
Mean ± Standard Deviation
  0.07  ± 0.76     0.03  ± 0.51     -0.14  ± 0.31     -0.62  ± 1.00  


Statistical Analysis 1 for Change From Baseline to the End of Treatment it Mean Serum Total Cholesterol Levels
Groups [1] 200 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.201
Mean Difference (Final Values) [4] 0.51
Standard Error of the mean ± 0.386
90% Confidence Interval ( -0.16 to 1.18 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment serum total cholesterol levels were analysed using a linear regression model, with end of treatment serum total cholesterol levels as the dependent variable, dose of GWP42003 as regressor, baseline serum total cholesterol levels as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline to the End of Treatment it Mean Serum Total Cholesterol Levels
Groups [1] 400 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.397
Mean Difference (Final Values) [4] 0.36
Standard Error of the mean ± 0.411
90% Confidence Interval ( -0.35 to 1.07 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment serum total cholesterol levels were analysed using a linear regression model, with end of treatment serum total cholesterol levels as the dependent variable, dose of GWP42003 as regressor, baseline serum total cholesterol levels as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Change From Baseline to the End of Treatment it Mean Serum Total Cholesterol Levels
Groups [1] 800 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.927
Mean Difference (Final Values) [4] 0.04
Standard Error of the mean ± 0.428
90% Confidence Interval ( -0.70 to 0.78 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment serum total cholesterol levels were analysed using a linear regression model, with end of treatment serum total cholesterol levels as the dependent variable, dose of GWP42003 as regressor, baseline serum total cholesterol levels as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



3.  Secondary:   Change From Baseline to the End of Treatment in Mean Serum High Density Lipoprotein (HDL)-Cholesterol(C) Levels   [ Time Frame: After 56 days of treatment ]

Measure Type Secondary
Measure Title Change From Baseline to the End of Treatment in Mean Serum High Density Lipoprotein (HDL)-Cholesterol(C) Levels
Measure Description A fasting blood sample was obtained for the measurement of HDL-C. An increase from baseline (i.e. a positive value) indicates an improvement in condition.
Time Frame After 56 days of treatment  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.

Reporting Groups
  Description
200 mg GWP42003 Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
400 mg GWP42003 Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
800 mg GWP42003 Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
Placebo Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.

Measured Values
    200 mg GWP42003     400 mg GWP42003     800 mg GWP42003     Placebo  
Number of Participants Analyzed  
[units: participants]
  7     6     7     5  
Change From Baseline to the End of Treatment in Mean Serum High Density Lipoprotein (HDL)-Cholesterol(C) Levels  
[units: mmol/l]
Mean ± Standard Deviation
  0.07  ± 0.15     0.08  ± 0.15     0.06  ± 0.17     -0.14  ± 0.23  


Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Serum High Density Lipoprotein (HDL)-Cholesterol(C) Levels
Groups [1] 200 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.186
Mean Difference (Final Values) [4] 0.14
Standard Error of the mean ± 0.101
90% Confidence Interval ( -0.04 to 0.31 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment serum HDL-C levels were analysed using a linear regression model, with end of treatment serum HDL-C levels as the dependent variable, dose of GWP42003 as regressor, baseline HDL-C levels as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Serum High Density Lipoprotein (HDL)-Cholesterol(C) Levels
Groups [1] 400 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.145
Mean Difference (Final Values) [4] 0.16
Standard Error of the mean ± 0.107
90% Confidence Interval ( -0.02 to 0.35 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment serum HDL-C levels were analysed using a linear regression model, with end of treatment serum HDL-C levels as the dependent variable, dose of GWP42003 as regressor, baseline HDL-C levels as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Serum High Density Lipoprotein (HDL)-Cholesterol(C) Levels
Groups [1] 800 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.304
Mean Difference (Final Values) [4] 0.11
Standard Error of the mean ± 0.108
90% Confidence Interval ( -0.07 to 0.30 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment serum HDL-C levels were analysed using a linear regression model, with end of treatment serum HDL-C levels as the dependent variable, dose of GWP42003 as regressor, baseline HDL-C levels as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



4.  Secondary:   Change From Baseline to the End of Treatment in Mean Serum Low Density Lipoprotein (LDL)-Cholesterol(C) Levels   [ Time Frame: After 56 days of treatment ]

Measure Type Secondary
Measure Title Change From Baseline to the End of Treatment in Mean Serum Low Density Lipoprotein (LDL)-Cholesterol(C) Levels
Measure Description A fasting blood sample was obtained for the measurement of LDL-C. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.
Time Frame After 56 days of treatment  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.

Reporting Groups
  Description
200 mg GWP42003 Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
400 mg GWP42003 Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
800 mg GWP42003 Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
Placebo Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.

Measured Values
    200 mg GWP42003     400 mg GWP42003     800 mg GWP42003     Placebo  
Number of Participants Analyzed  
[units: participants]
  7     6     7     5  
Change From Baseline to the End of Treatment in Mean Serum Low Density Lipoprotein (LDL)-Cholesterol(C) Levels  
[units: mmol/l]
Mean ± Standard Deviation
  0.11  ± 0.63     0.08  ± 0.41     0.00  ± 0.43     -0.34  ± 0.74  


Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Serum Low Density Lipoprotein (LDL)-Cholesterol(C) Levels
Groups [1] 200 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.302
Mean Difference (Final Values) [4] 0.31
Standard Error of the mean ± 0.289
90% Confidence Interval ( -0.19 to 0.81 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment serum LDL-C levels were analysed using a linear regression model, with end of treatment serum LDL-C levels as the dependent variable, dose of GWP42003 as regressor, baseline LDL-C levels as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Serum Low Density Lipoprotein (LDL)-Cholesterol(C) Levels
Groups [1] 400 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.564
Mean Difference (Final Values) [4] 0.18
Standard Error of the mean ± 0.308
90% Confidence Interval ( -0.35 to 0.71 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment serum LDL-C levels were analysed using a linear regression model, with end of treatment serum LDL-C levels as the dependent variable, dose of GWP42003 as regressor, baseline LDL-C levels as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Serum Low Density Lipoprotein (LDL)-Cholesterol(C) Levels
Groups [1] 800 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.874
Mean Difference (Final Values) [4] -0.05
Standard Error of the mean ± 0.309
90% Confidence Interval ( -0.58 to 0.49 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment serum LDL-C levels were analysed using a linear regression model, with end of treatment serum LDL-C levels as the dependent variable, dose of GWP42003 as regressor, baseline LDL-C levels as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



5.  Secondary:   Change From Baseline to the End of Treatment it the Mean Serum HDL:LDL Cholesterol Ratio   [ Time Frame: After 56 days of treatment ]

Measure Type Secondary
Measure Title Change From Baseline to the End of Treatment it the Mean Serum HDL:LDL Cholesterol Ratio
Measure Description A fasting blood sample was obtained for the measurement of HDL-C and LDL-C, allowing the HDL:LDL cholesterol ratio to be calculated. An increase from baseline (i.e. a positive value) indicates an improvement in condition.
Time Frame After 56 days of treatment  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.

Reporting Groups
  Description
200 mg GWP42003 Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
400 mg GWP42003 Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
800 mg GWP42003 Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
Placebo Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.

Measured Values
    200 mg GWP42003     400 mg GWP42003     800 mg GWP42003     Placebo  
Number of Participants Analyzed  
[units: participants]
  7     6     7     5  
Change From Baseline to the End of Treatment it the Mean Serum HDL:LDL Cholesterol Ratio  
[units: ratio]
Mean ± Standard Deviation
  -0.02  ± 0.13     -0.00  ± 0.08     0.03  ± 0.09     0.01  ± 0.06  


Statistical Analysis 1 for Change From Baseline to the End of Treatment it the Mean Serum HDL:LDL Cholesterol Ratio
Groups [1] 200 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.703
Mean Difference (Final Values) [4] -0.01
Standard Error of the mean ± 0.035
90% Confidence Interval ( -0.07 to 0.05 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment serum serum HDL:LDL cholesterol ratio was analysed using a linear regression model, with end of treatment serum HDL:LDL cholesterol ratio as the dependent variable, dose of GWP42003 as regressor, baseline serum HDL:LDL cholesterol ratio as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline to the End of Treatment it the Mean Serum HDL:LDL Cholesterol Ratio
Groups [1] 400 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.532
Mean Difference (Final Values) [4] 0.02
Standard Error of the mean ± 0.039
90% Confidence Interval ( -0.04 to 0.09 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment serum serum HDL:LDL cholesterol ratio was analysed using a linear regression model, with end of treatment serum HDL:LDL cholesterol ratio as the dependent variable, dose of GWP42003 as regressor, baseline serum HDL:LDL cholesterol ratio as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Change From Baseline to the End of Treatment it the Mean Serum HDL:LDL Cholesterol Ratio
Groups [1] 800 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.087
Mean Difference (Final Values) [4] 0.07
Standard Error of the mean ± 0.038
90% Confidence Interval ( 0.00 to 0.13 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment serum serum HDL:LDL cholesterol ratio was analysed using a linear regression model, with end of treatment serum HDL:LDL cholesterol ratio as the dependent variable, dose of GWP42003 as regressor, baseline serum HDL:LDL cholesterol ratio as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



6.  Secondary:   Change From Baseline to the End of Treatment in Mean Serum Triglyceride Levels   [ Time Frame: After 56 days of treatment ]

Measure Type Secondary
Measure Title Change From Baseline to the End of Treatment in Mean Serum Triglyceride Levels
Measure Description A fasting blood sample was obtained for the measurement of serum triglycerides. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.
Time Frame After 56 days of treatment  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.

Reporting Groups
  Description
200 mg GWP42003 Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
400 mg GWP42003 Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
800 mg GWP42003 Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
Placebo Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.

Measured Values
    200 mg GWP42003     400 mg GWP42003     800 mg GWP42003     Placebo  
Number of Participants Analyzed  
[units: participants]
  7     6     7     5  
Change From Baseline to the End of Treatment in Mean Serum Triglyceride Levels  
[units: mmol/l]
Mean ± Standard Deviation
  -0.40  ± 1.05     -0.29  ± 0.82     -0.50  ± 1.16     -0.28  ± 0.39  


Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Serum Triglyceride Levels
Groups [1] 200 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.556
Mean Difference (Final Values) [4] 0.22
Standard Error of the mean ± 0.374
90% Confidence Interval ( -0.42 to 0.87 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment serum triglyceride levels were analysed using a linear regression model, with end of treatment serum triglyceride levels as the dependent variable, dose of GWP42003 as regressor, baseline serum triglyceride levels as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Serum Triglyceride Levels
Groups [1] 400 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.458
Mean Difference (Final Values) [4] -0.31
Standard Error of the mean ± 0.409
90% Confidence Interval ( -1.02 to 0.40 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment serum triglyceride levels were analysed using a linear regression model, with end of treatment serum triglyceride levels as the dependent variable, dose of GWP42003 as regressor, baseline serum triglyceride levels as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Serum Triglyceride Levels
Groups [1] 800 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.868
Mean Difference (Final Values) [4] -0.07
Standard Error of the mean ± 0.395
90% Confidence Interval ( -0.75 to 0.62 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment serum triglyceride levels were analysed using a linear regression model, with end of treatment serum triglyceride levels as the dependent variable, dose of GWP42003 as regressor, baseline serum triglyceride levels as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



7.  Secondary:   Change From Baseline to the End of Treatment in Mean Fasting Plasma Glucose Levels   [ Time Frame: After 56 days of treatment ]

Measure Type Secondary
Measure Title Change From Baseline to the End of Treatment in Mean Fasting Plasma Glucose Levels
Measure Description A fasting blood sample was obtained for the measurement of fasting plasma glucose. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.
Time Frame After 56 days of treatment  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.

Reporting Groups
  Description
200 mg GWP42003 Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
400 mg GWP42003 Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003 .
800 mg GWP42003 Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
Placebo Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.

Measured Values
    200 mg GWP42003     400 mg GWP42003     800 mg GWP42003     Placebo  
Number of Participants Analyzed  
[units: participants]
  7     6     7     4  
Change From Baseline to the End of Treatment in Mean Fasting Plasma Glucose Levels  
[units: mmol/l]
Mean ± Standard Deviation
  -0.01  ± 0.35     0.20  ± 0.28     0.10  ± 0.35     -0.13  ± 0.49  


Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Fasting Plasma Glucose Levels
Groups [1] 200 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.602
Mean Difference (Final Values) [4] 0.10
Standard Error of the mean ± 0.181
90% Confidence Interval ( -0.22 to 0.41 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fasting plasma glucose levels were analysed using a linear regression model, with end of treatment fasting plasma glucose levels as the dependent variable, dose of GWP42003 as regressor, baseline fasting plasma glucose levels as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Fasting Plasma Glucose Levels
Groups [1] 400 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.380
Mean Difference (Final Values) [4] 0.18
Standard Error of the mean ± 0.195
90% Confidence Interval ( -0.16 to 0.52 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fasting plasma glucose levels were analysed using a linear regression model, with end of treatment fasting plasma glucose levels as the dependent variable, dose of GWP42003 as regressor, baseline fasting plasma glucose levels as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Fasting Plasma Glucose Levels
Groups [1] 800 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.832
Mean Difference (Final Values) [4] 0.04
Standard Error of the mean ± 0.193
90% Confidence Interval ( -0.29 to 0.38 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fasting plasma glucose levels were analysed using a linear regression model, with end of treatment fasting plasma glucose levels as the dependent variable, dose of GWP42003 as regressor, baseline fasting plasma glucose levels as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



8.  Secondary:   Change From Baseline to the End of Treatment in Mean Body Mass Index (BMI)   [ Time Frame: After 56 days of treatment ]

Measure Type Secondary
Measure Title Change From Baseline to the End of Treatment in Mean Body Mass Index (BMI)
Measure Description Individual subject's BMIs were calculated by dividing mass (kg) by height (m2). A reduction from baseline (i.e. a negative value) indicates an improvement in condition.
Time Frame After 56 days of treatment  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.

Reporting Groups
  Description
200 mg GWP42003 Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
400 mg GWP42003 Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
800 mg GWP42003 Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
Placebo Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.

Measured Values
    200 mg GWP42003     400 mg GWP42003     800 mg GWP42003     Placebo  
Number of Participants Analyzed  
[units: participants]
  7     6     7     5  
Change From Baseline to the End of Treatment in Mean Body Mass Index (BMI)  
[units: kg/m2]
Mean ± Standard Deviation
  0.11  ± 0.24     0.31  ± 0.34     -0.10  ± 0.25     -0.38  ± 1.28  


Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Body Mass Index (BMI)
Groups [1] 200 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.351
Mean Difference (Final Values) [4] 0.35
Standard Error of the mean ± 0.371
90% Confidence Interval ( -0.29 to 1.00 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment BMIs were analysed using a linear regression model, with end of treatment BMI as the dependent variable, dose of GWP42003 as regressor, baseline BMI as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Body Mass Index (BMI)
Groups [1] 400 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.185
Mean Difference (Final Values) [4] 0.53
Standard Error of the mean ± 0.388
90% Confidence Interval ( -0.14 to 1.20 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment BMIs were analysed using a linear regression model, with end of treatment BMI as the dependent variable, dose of GWP42003 as regressor, baseline BMI as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Body Mass Index (BMI)
Groups [1] 800 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.685
Mean Difference (Final Values) [4] 0.16
Standard Error of the mean ± 0.383
90% Confidence Interval ( -0.50 to 0.82 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment BMIs were analysed using a linear regression model, with end of treatment BMI as the dependent variable, dose of GWP42003 as regressor, baseline BMI as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



9.  Secondary:   Change From Baseline to the End of Treatment in Mean Body Weight   [ Time Frame: After 56 days of treatment ]

Measure Type Secondary
Measure Title Change From Baseline to the End of Treatment in Mean Body Weight
Measure Description Body weight (kg) was measured at baseline and the end of treatment. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.
Time Frame After 56 days of treatment  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.

Reporting Groups
  Description
200 mg GWP42003 Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
400 mg GWP42003 Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
800 mg GWP42003 Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
Placebo Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.

Measured Values
    200 mg GWP42003     400 mg GWP42003     800 mg GWP42003     Placebo  
Number of Participants Analyzed  
[units: participants]
  7     6     7     5  
Change From Baseline to the End of Treatment in Mean Body Weight  
[units: kg]
Mean ± Standard Deviation
  0.33  ± 0.68     0.95  ± 1.02     -0.24  ± 0.67     -1.00  ± 3.27  


Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Body Weight
Groups [1] 200 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.319
Mean Difference (Final Values) [4] 0.94
Standard Error of the mean ± 0.923
90% Confidence Interval ( -0.65 to 2.54 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment body weight measurements were analysed using a linear regression model, with end of treatment body weight as the dependent variable, dose of GWP42003 as regressor, baseline body weight as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Body Weight
Groups [1] 400 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.145
Mean Difference (Final Values) [4] 1.49
Standard Error of the mean ± 0.980
90% Confidence Interval ( -0.20 to 3.19 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment body weight measurements were analysed using a linear regression model, with end of treatment body weight as the dependent variable, dose of GWP42003 as regressor, baseline body weight as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Body Weight
Groups [1] 800 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.562
Mean Difference (Final Values) [4] 0.58
Standard Error of the mean ± 0.986
90% Confidence Interval ( -1.12 to 2.29 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment body weight measurements were analysed using a linear regression model, with end of treatment body weight as the dependent variable, dose of GWP42003 as regressor, baseline body weight as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



10.  Secondary:   Change From Baseline to the End of Treatment in Mean Waist-to-hip Ratio   [ Time Frame: After 56 days of treatment ]

Measure Type Secondary
Measure Title Change From Baseline to the End of Treatment in Mean Waist-to-hip Ratio
Measure Description The waist-to-hip ratio was calculated at baseline and the end of treatment. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.
Time Frame After 56 days of treatment  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.

Reporting Groups
  Description
200 mg GWP42003 Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
400 mg GWP42003 Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
800 mg GWP42003 Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
Placebo Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.

Measured Values
    200 mg GWP42003     400 mg GWP42003     800 mg GWP42003     Placebo  
Number of Participants Analyzed  
[units: participants]
  7     6     7     5  
Change From Baseline to the End of Treatment in Mean Waist-to-hip Ratio  
[units: ratio]
Mean ± Standard Deviation
  -0.02  ± 0.08     -0.01  ± 0.06     -0.01  ± 0.02     0.00  ± 0.01  


Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Waist-to-hip Ratio
Groups [1] 200 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.386
Mean Difference (Final Values) [4] -0.016
Standard Error of the mean ± 0.018
90% Confidence Interval ( -0.048 to 0.015 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment waist-to-hip ratio was analysed using a linear regression model, with end of treatment waist-to-hip ratio as the dependent variable, dose of GWP42003 as regressor, baseline waist-to-hip ratio as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Waist-to-hip Ratio
Groups [1] 400 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.968
Mean Difference (Final Values) [4] 0.001
Standard Error of the mean ± 0.020
90% Confidence Interval ( -0.034 to 0.035 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment waist-to-hip ratio was analysed using a linear regression model, with end of treatment waist-to-hip ratio as the dependent variable, dose of GWP42003 as regressor, baseline waist-to-hip ratio as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Waist-to-hip Ratio
Groups [1] 800 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.193
Mean Difference (Final Values) [4] -0.027
Standard Error of the mean ± 0.020
90% Confidence Interval ( -0.061 to 0.008 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment waist-to-hip ratio was analysed using a linear regression model, with end of treatment waist-to-hip ratio as the dependent variable, dose of GWP42003 as regressor, baseline waist-to-hip ratio as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



11.  Secondary:   Change From Baseline to the End of Treatment in Mean Neck Measurement   [ Time Frame: After 56 days of treatment ]

Measure Type Secondary
Measure Title Change From Baseline to the End of Treatment in Mean Neck Measurement
Measure Description The neck circumference was measured at baseline and the end of treatment. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.
Time Frame After 56 days of treatment  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.

Reporting Groups
  Description
200 mg GWP42003 Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
400 mg GWP42003 Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
800 mg GWP42003 Subjects self-administered four x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
Placebo Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.

Measured Values
    200 mg GWP42003     400 mg GWP42003     800 mg GWP42003     Placebo  
Number of Participants Analyzed  
[units: participants]
  7     6     7     5  
Change From Baseline to the End of Treatment in Mean Neck Measurement  
[units: cm]
Mean ± Standard Deviation
  -1.21  ± 3.66     -2.65  ± 3.18     -0.44  ± 0.86     1.24  ± 1.42  


Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Neck Measurement
Groups [1] 200 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.334
Mean Difference (Final Values) [4] -1.68
Standard Error of the mean ± 1.697
90% Confidence Interval ( -4.62 to 1.25 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment neck measurement was analysed using a linear regression model, with end of treatment neck measurement as the dependent variable, dose of GWP42003 as regressor, baseline neck measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Neck Measurement
Groups [1] 400 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.109
Mean Difference (Final Values) [4] -3.13
Standard Error of the mean ± 1.862
90% Confidence Interval ( -6.35 to 0.09 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment neck measurement was analysed using a linear regression model, with end of treatment neck measurement as the dependent variable, dose of GWP42003 as regressor, baseline neck measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Neck Measurement
Groups [1] 800 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.539
Mean Difference (Final Values) [4] -1.11
Standard Error of the mean ± 1.776
90% Confidence Interval ( -4.18 to 1.96 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment neck measurement was analysed using a linear regression model, with end of treatment neck measurement as the dependent variable, dose of GWP42003 as regressor, baseline neck measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



12.  Secondary:   Change From Baseline to the End of Treatment in Mean Waist Measurement   [ Time Frame: After 56 days of treatment ]

Measure Type Secondary
Measure Title Change From Baseline to the End of Treatment in Mean Waist Measurement
Measure Description Waist circumference was measured at baseline and the end of treatment. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.
Time Frame After 56 days of treatment  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.

Reporting Groups
  Description
200 mg GWP42003 Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
400 mg GWP42003 Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
800 mg GWP42003 Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
Placebo Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.

Measured Values
    200 mg GWP42003     400 mg GWP42003     800 mg GWP42003     Placebo  
Number of Participants Analyzed  
[units: participants]
  7     6     7     5  
Change From Baseline to the End of Treatment in Mean Waist Measurement  
[units: cm]
Mean ± Standard Deviation
  -4.29  ± 8.24     -1.20  ± 5.94     -1.44  ± 2.76     -2.58  ± 4.38  


Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Waist Measurement
Groups [1] 200 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.613
Mean Difference (Final Values) [4] -1.53
Standard Error of the mean ± 2.980
90% Confidence Interval ( -6.68 to 3.62 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment waist measurement was analysed using a linear regression model, with end of treatment waist measurement as the dependent variable, dose of GWP42003 as regressor, baseline waist measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Waist Measurement
Groups [1] 400 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.965
Mean Difference (Final Values) [4] 0.15
Standard Error of the mean ± 3.286
90% Confidence Interval ( -5.54 to 5.83 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment waist measurement was analysed using a linear regression model, with end of treatment waist measurement as the dependent variable, dose of GWP42003 as regressor, baseline waist measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Waist Measurement
Groups [1] 800 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.550
Mean Difference (Final Values) [4] -2.07
Standard Error of the mean ± 3.396
90% Confidence Interval ( -7.94 to 3.81 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment waist measurement was analysed using a linear regression model, with end of treatment waist measurement as the dependent variable, dose of GWP42003 as regressor, baseline waist measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



13.  Secondary:   Change From Baseline to the End of Treatment in Mean Hip Measurement   [ Time Frame: After 56 days of treatment ]

Measure Type Secondary
Measure Title Change From Baseline to the End of Treatment in Mean Hip Measurement
Measure Description Hip circumference was measured at baseline and the end of treatment. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.
Time Frame After 56 days of treatment  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.

Reporting Groups
  Description
200 mg GWP42003 Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
400 mg GWP42003 Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
800 mg GWP42003 Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
Placebo Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.

Measured Values
    200 mg GWP42003     400 mg GWP42003     800 mg GWP42003     Placebo  
Number of Participants Analyzed  
[units: participants]
  7     6     7     5  
Change From Baseline to the End of Treatment in Mean Hip Measurement  
[units: cm]
Mean ± Standard Deviation
  -2.74  ± 6.04     -0.38  ± 3.47     -0.39  ± 1.31     -3.28  ± 5.45  


Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Hip Measurement
Groups [1] 200 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.906
Mean Difference (Final Values) [4] 0.30
Standard Error of the mean ± 2.513
90% Confidence Interval ( -4.04 to 4.65 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment hip measurement was analysed using a linear regression model, with end of treatment hip measurement as the dependent variable, dose of GWP42003 as regressor, baseline hip measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Hip Measurement
Groups [1] 400 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.666
Mean Difference (Final Values) [4] 1.22
Standard Error of the mean ± 2.787
90% Confidence Interval ( -3.60 to 6.04 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment hip measurement was analysed using a linear regression model, with end of treatment hip measurement as the dependent variable, dose of GWP42003 as regressor, baseline hip measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Hip Measurement
Groups [1] 800 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.722
Mean Difference (Final Values) [4] 1.00
Standard Error of the mean ± 2.755
90% Confidence Interval ( -3.77 to 5.76 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment hip measurement was analysed using a linear regression model, with end of treatment hip measurement as the dependent variable, dose of GWP42003 as regressor, baseline hip measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



14.  Secondary:   Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Chest/Pectoral)   [ Time Frame: After 56 days of treatment ]

Measure Type Secondary
Measure Title Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Chest/Pectoral)
Measure Description Skin fold thickness measurements were the mean of three measurements per site calculated for each subject. If one or more measurements were missing for a site, then the mean was calculated over the available measurement(s) for that site. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.
Time Frame After 56 days of treatment  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.

Reporting Groups
  Description
200 mg GWP42003 Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
400 mg GWP42003 Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
800 mg GWP42003 Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
Placebo Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.

Measured Values
    200 mg GWP42003     400 mg GWP42003     800 mg GWP42003     Placebo  
Number of Participants Analyzed  
[units: participants]
  7     6     7     5  
Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Chest/Pectoral)  
[units: mm]
Mean ± Standard Deviation
  8.30  ± 15.69     4.12  ± 15.34     5.26  ± 12.25     5.86  ± 10.18  


Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Chest/Pectoral)
Groups [1] 200 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.494
Mean Difference (Final Values) [4] 5.67
Standard Error of the mean ± 8.130
90% Confidence Interval ( -8.38 to 19.73 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment skin fold thickness measurements were analysed using a linear regression model, with end of treatment skin fold thickness measurement as the dependent variable, dose of GWP42003 as regressor, baseline skin fold thickness measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Chest/Pectoral)
Groups [1] 400 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.613
Mean Difference (Final Values) [4] 4.67
Standard Error of the mean ± 9.066
90% Confidence Interval ( -11.01 to 20.34 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment skin fold thickness measurements were analysed using a linear regression model, with end of treatment skin fold thickness measurement as the dependent variable, dose of GWP42003 as regressor, baseline skin fold thickness measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Chest/Pectoral)
Groups [1] 800 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.541
Mean Difference (Final Values) [4] 5.49
Standard Error of the mean ± 8.813
90% Confidence Interval ( -9.75 to 20.73 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment skin fold thickness measurements were analysed using a linear regression model, with end of treatment skin fold thickness measurement as the dependent variable, dose of GWP42003 as regressor, baseline skin fold thickness measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



15.  Secondary:   Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Midaxillary)   [ Time Frame: After 56 days of treatment ]

Measure Type Secondary
Measure Title Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Midaxillary)
Measure Description Skin fold thickness measurements were the mean of three measurements per site calculated for each subject. If one or more measurements were missing for a site, then the mean was calculated over the available measurement(s) for that site. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.
Time Frame After 56 days of treatment  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.

Reporting Groups
  Description
200 mg GWP42003 Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
400 mg GWP42003 Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
800 mg GWP42003 Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
Placebo Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.

Measured Values
    200 mg GWP42003     400 mg GWP42003     800 mg GWP42003     Placebo  
Number of Participants Analyzed  
[units: participants]
  7     6     7     5  
Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Midaxillary)  
[units: mm]
Mean ± Standard Deviation
  1.8  ± 10.10     2.4  ± 9.30     3.8  ± 10.69     6.1  ± 4.16  


Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Midaxillary)
Groups [1] 200 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.858
Mean Difference (Final Values) [4] -1.00
Standard Error of the mean ± 5.536
90% Confidence Interval ( -10.58 to 8.57 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment skin fold thickness measurements were analysed using a linear regression model, with end of treatment skin fold thickness measurement as the dependent variable, dose of GWP42003 as regressor, baseline skin fold thickness measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Midaxillary)
Groups [1] 400 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.855
Mean Difference (Final Values) [4] 1.08
Standard Error of the mean ± 5.826
90% Confidence Interval ( -9.00 to 11.15 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment skin fold thickness measurements were analysed using a linear regression model, with end of treatment skin fold thickness measurement as the dependent variable, dose of GWP42003 as regressor, baseline skin fold thickness measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Midaxillary)
Groups [1] 800 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.660
Mean Difference (Final Values) [4] 2.55
Standard Error of the mean ± 5.700
90% Confidence Interval ( -7.31 to 12.40 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment skin fold thickness measurements were analysed using a linear regression model, with end of treatment skin fold thickness measurement as the dependent variable, dose of GWP42003 as regressor, baseline skin fold thickness measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



16.  Secondary:   Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Triceps)   [ Time Frame: After 56 days of treatment ]

Measure Type Secondary
Measure Title Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Triceps)
Measure Description Skin fold thickness measurements were the mean of three measurements per site calculated for each subject. If one or more measurements were missing for a site, then the mean was calculated over the available measurement(s) for that site. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.
Time Frame After 56 days of treatment  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.

Reporting Groups
  Description
200 mg GWP42003 Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
400 mg GWP42003 Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
800 mg GWP42003 Subjects self-administered four x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
Placebo Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.

Measured Values
    200 mg GWP42003     400 mg GWP42003     800 mg GWP42003     Placebo  
Number of Participants Analyzed  
[units: participants]
  7     6     7     5  
Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Triceps)  
[units: mm]
Mean ± Standard Deviation
  1.9  ± 8.26     4.0  ± 9.32     -0.7  ± 13.32     4.0  ± 12.33  


Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Triceps)
Groups [1] 200 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.768
Mean Difference (Final Values) [4] 2.09
Standard Error of the mean ± 6.987
90% Confidence Interval ( -9.99 to 14.17 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment skin fold thickness measurements were analysed using a linear regression model, with end of treatment skin fold thickness measurement as the dependent variable, dose of GWP42003 as regressor, baseline skin fold thickness measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Triceps)
Groups [1] 400 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.534
Mean Difference (Final Values) [4] 4.68
Standard Error of the mean ± 7.393
90% Confidence Interval ( -8.10 to 17.47 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment skin fold thickness measurements were analysed using a linear regression model, with end of treatment skin fold thickness measurement as the dependent variable, dose of GWP42003 as regressor, baseline skin fold thickness measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Triceps)
Groups [1] 800 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.875
Mean Difference (Final Values) [4] 1.21
Standard Error of the mean ± 7.579
90% Confidence Interval ( -11.89 to 14.31 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment skin fold thickness measurements were analysed using a linear regression model, with end of treatment skin fold thickness measurement as the dependent variable, dose of GWP42003 as regressor, baseline skin fold thickness measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



17.  Secondary:   Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Subscapular)   [ Time Frame: After 56 days of treatment ]

Measure Type Secondary
Measure Title Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Subscapular)
Measure Description Skin fold thickness measurements were the mean of three measurements per site calculated for each subject. If one or more measurements were missing for a site, then the mean was calculated over the available measurement(s) for that site. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.
Time Frame After 56 days of treatment  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.

Reporting Groups
  Description
200 mg GWP42003 Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
400 mg GWP42003 Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
800 mg GWP42003 Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
Placebo Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.

Measured Values
    200 mg GWP42003     400 mg GWP42003     800 mg GWP42003     Placebo  
Number of Participants Analyzed  
[units: participants]
  7     6     7     5  
Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Subscapular)  
[units: mm]
Mean ± Standard Deviation
  3.0  ± 5.70     0.6  ± 7.30     3.7  ± 9.15     4.0  ± 9.48  


Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Subscapular)
Groups [1] 200 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.971
Mean Difference (Final Values) [4] -0.20
Standard Error of the mean ± 5.344
90% Confidence Interval ( -9.44 to 9.04 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment skin fold thickness measurements were analysed using a linear regression model, with end of treatment skin fold thickness measurement as the dependent variable, dose of GWP42003 as regressor, baseline skin fold thickness measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Subscapular)
Groups [1] 400 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.794
Mean Difference (Final Values) [4] -1.49
Standard Error of the mean ± 5.650
90% Confidence Interval ( -11.26 to 8.28 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment skin fold thickness measurements were analysed using a linear regression model, with end of treatment skin fold thickness measurement as the dependent variable, dose of GWP42003 as regressor, baseline skin fold thickness measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Subscapular)
Groups [1] 800 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.753
Mean Difference (Final Values) [4] 1.77
Standard Error of the mean ± 5.547
90% Confidence Interval ( -7.82 to 11.37 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment skin fold thickness measurements were analysed using a linear regression model, with end of treatment skin fold thickness measurement as the dependent variable, dose of GWP42003 as regressor, baseline skin fold thickness measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



18.  Secondary:   Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Abdomen)   [ Time Frame: After 56 days of treatment ]

Measure Type Secondary
Measure Title Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Abdomen)
Measure Description Skin fold thickness measurements were the mean of three measurements per site calculated for each subject. If one or more measurements were missing for a site, then the mean was calculated over the available measurement(s) for that site. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.
Time Frame After 56 days of treatment  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.

Reporting Groups
  Description
200 mg GWP42003 Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
400 mg GWP42003 Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
800 mg GWP42003 Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
Placebo Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.

Measured Values
    200 mg GWP42003     400 mg GWP42003     800 mg GWP42003     Placebo  
Number of Participants Analyzed  
[units: participants]
  7     6     7     5  
Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Abdomen)  
[units: mm]
Mean ± Standard Deviation
  1.3  ± 9.21     4.6  ± 12.59     5.2  ± 12.35     4.2  ± 11.13  


Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Abdomen)
Groups [1] 200 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.830
Mean Difference (Final Values) [4] -1.54
Standard Error of the mean ± 7.075
90% Confidence Interval ( -13.77 to 10.70 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment skin fold thickness measurements were analysed using a linear regression model, with end of treatment skin fold thickness measurement as the dependent variable, dose of GWP42003 as regressor, baseline skin fold thickness measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Abdomen)
Groups [1] 400 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.946
Mean Difference (Final Values) [4] 0.52
Standard Error of the mean ± 7.626
90% Confidence Interval ( -12.66 to 13.71 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment skin fold thickness measurements were analysed using a linear regression model, with end of treatment skin fold thickness measurement as the dependent variable, dose of GWP42003 as regressor, baseline skin fold thickness measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Abdomen)
Groups [1] 800 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.901
Mean Difference (Final Values) [4] 0.94
Standard Error of the mean ± 7.475
90% Confidence Interval ( -11.99 to 13.86 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment skin fold thickness measurements were analysed using a linear regression model, with end of treatment skin fold thickness measurement as the dependent variable, dose of GWP42003 as regressor, baseline skin fold thickness measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



19.  Secondary:   Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Suprailiac)   [ Time Frame: After 56 days of treatment ]

Measure Type Secondary
Measure Title Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Suprailiac)
Measure Description Skin fold thickness measurements were the mean of three measurements per site calculated for each subject. If one or more measurements were missing for a site, then the mean was calculated over the available measurement(s) for that site. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.
Time Frame After 56 days of treatment  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.

Reporting Groups
  Description
200 mg GWP42003 Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
400 mg GWP42003 Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
800 mg GWP42003 Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
Placebo Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.

Measured Values
    200 mg GWP42003     400 mg GWP42003     800 mg GWP42003     Placebo  
Number of Participants Analyzed  
[units: participants]
  7     6     7     5  
Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Suprailiac)  
[units: mm]
Mean ± Standard Deviation
  3.6  ± 8.16     6.8  ± 11.38     5.2  ± 8.27     2.0  ± 11.03  


Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Suprailiac)
Groups [1] 200 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.704
Mean Difference (Final Values) [4] 2.30
Standard Error of the mean ± 5.952
90% Confidence Interval ( -7.99 to 12.59 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment skin fold thickness measurements were analysed using a linear regression model, with end of treatment skin fold thickness measurement as the dependent variable, dose of GWP42003 as regressor, baseline skin fold thickness measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Suprailiac)
Groups [1] 400 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.365
Mean Difference (Final Values) [4] 5.99
Standard Error of the mean ± 6.458
90% Confidence Interval ( -5.18 to 17.16 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment skin fold thickness measurements were analysed using a linear regression model, with end of treatment skin fold thickness measurement as the dependent variable, dose of GWP42003 as regressor, baseline skin fold thickness measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Suprailiac)
Groups [1] 800 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.493
Mean Difference (Final Values) [4] 4.44
Standard Error of the mean ± 6.339
90% Confidence Interval ( -6.53 to 15.40 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment skin fold thickness measurements were analysed using a linear regression model, with end of treatment skin fold thickness measurement as the dependent variable, dose of GWP42003 as regressor, baseline skin fold thickness measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



20.  Secondary:   Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Thigh)   [ Time Frame: After 56 days of treatment ]

Measure Type Secondary
Measure Title Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Thigh)
Measure Description Skin fold thickness measurements were the mean of three measurements per site calculated for each subject. If one or more measurements were missing for a site, then the mean was calculated over the available measurement(s) for that site. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.
Time Frame After 56 days of treatment  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.

Reporting Groups
  Description
200 mg GWP42003 Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
400 mg GWP42003 Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
800 mg GWP42003 Subjects self-administered four x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
Placebo Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.

Measured Values
    200 mg GWP42003     400 mg GWP42003     800 mg GWP42003     Placebo  
Number of Participants Analyzed  
[units: participants]
  7     6     7     5  
Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Thigh)  
[units: mm]
Mean ± Standard Deviation
  -4.2  ± 11.77     6.1  ± 13.77     1.6  ± 10.47     3.7  ± 6.13  


Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Thigh)
Groups [1] 200 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.679
Mean Difference (Final Values) [4] -2.61
Standard Error of the mean ± 6.230
90% Confidence Interval ( -13.39 to 8.16 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment skin fold thickness measurements were analysed using a linear regression model, with end of treatment skin fold thickness measurement as the dependent variable, dose of GWP42003 as regressor, baseline skin fold thickness measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Thigh)
Groups [1] 400 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.424
Mean Difference (Final Values) [4] 5.32
Standard Error of the mean ± 6.516
90% Confidence Interval ( -5.94 to 16.59 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment skin fold thickness measurements were analysed using a linear regression model, with end of treatment skin fold thickness measurement as the dependent variable, dose of GWP42003 as regressor, baseline skin fold thickness measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Thigh)
Groups [1] 800 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.801
Mean Difference (Final Values) [4] 1.65
Standard Error of the mean ± 6.460
90% Confidence Interval ( -9.52 to 12.82 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment skin fold thickness measurements were analysed using a linear regression model, with end of treatment skin fold thickness measurement as the dependent variable, dose of GWP42003 as regressor, baseline skin fold thickness measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



21.  Secondary:   Change From Baseline to the End of Treatment in Mean Total Skin-fold Thickness   [ Time Frame: After 56 days of treatment ]

Measure Type Secondary
Measure Title Change From Baseline to the End of Treatment in Mean Total Skin-fold Thickness
Measure Description Total skin fold thickness was based on the sum of the average values from the seven sites stated above. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.
Time Frame After 56 days of treatment  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.

Reporting Groups
  Description
200 mg GWP42003 Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
400 mg GWP42003 Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
800 mg GWP42003 Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
Placebo Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.

Measured Values
    200 mg GWP42003     400 mg GWP42003     800 mg GWP42003     Placebo  
Number of Participants Analyzed  
[units: participants]
  7     6     7     5  
Change From Baseline to the End of Treatment in Mean Total Skin-fold Thickness  
[units: mm]
Mean ± Standard Deviation
  15.7  ± 56.76     28.6  ± 70.03     24.1  ± 57.09     29.7  ± 54.58  


Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Total Skin-fold Thickness
Groups [1] 200 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.954
Mean Difference (Final Values) [4] -2.23
Standard Error of the mean ± 38.430
90% Confidence Interval ( -68.68 to 64.22 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment skin fold thickness measurements were analysed using a linear regression model, with end of treatment skin fold thickness measurement as the dependent variable, dose of GWP42003 as regressor, baseline skin fold thickness measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Total Skin-fold Thickness
Groups [1] 400 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.716
Mean Difference (Final Values) [4] 15.12
Standard Error of the mean ± 40.950
90% Confidence Interval ( -55.69 to 85.93 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment skin fold thickness measurements were analysed using a linear regression model, with end of treatment skin fold thickness measurement as the dependent variable, dose of GWP42003 as regressor, baseline skin fold thickness measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Total Skin-fold Thickness
Groups [1] 800 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.776
Mean Difference (Final Values) [4] 11.66
Standard Error of the mean ± 40.387
90% Confidence Interval ( -58.18 to 81.49 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment skin fold thickness measurements were analysed using a linear regression model, with end of treatment skin fold thickness measurement as the dependent variable, dose of GWP42003 as regressor, baseline skin fold thickness measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



22.  Secondary:   Change From Baseline to the End of Treatment in Mean Visceral Abdominal Fat   [ Time Frame: After 56 days of treatment ]

Measure Type Secondary
Measure Title Change From Baseline to the End of Treatment in Mean Visceral Abdominal Fat
Measure Description As measured by MRI/MRS scanning. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.
Time Frame After 56 days of treatment  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.

Reporting Groups
  Description
200 mg GWP42003 Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
400 mg GWP42003 Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
800 mg GWP42003 Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
Placebo Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.

Measured Values
    200 mg GWP42003     400 mg GWP42003     800 mg GWP42003     Placebo  
Number of Participants Analyzed  
[units: participants]
  7     6     6     5  
Change From Baseline to the End of Treatment in Mean Visceral Abdominal Fat  
[units: litres]
Mean ± Standard Deviation
  0.21  ± 0.41     -0.06  ± 0.22     0.25  ± 1.08     -0.77  ± 1.96  


Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Visceral Abdominal Fat
Groups [1] 200 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.091
Mean Difference (Final Values) [4] 1.03
Standard Error of the mean ± 0.579
90% Confidence Interval ( 0.03 to 2.04 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fat measurements were analysed using a linear regression model, with end of treatment fat measurement as the dependent variable, dose of GWP42003 as regressor, baseline fat measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Visceral Abdominal Fat
Groups [1] 400 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.087
Mean Difference (Final Values) [4] 1.16
Standard Error of the mean ± 0.642
90% Confidence Interval ( 0.05 to 2.28 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fat measurements were analysed using a linear regression model, with end of treatment fat measurement as the dependent variable, dose of GWP42003 as regressor, baseline fat measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Visceral Abdominal Fat
Groups [1] 800 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.063
Mean Difference (Final Values) [4] 1.25
Standard Error of the mean ± 0.633
90% Confidence Interval ( 0.16 to 2.35 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fat measurements were analysed using a linear regression model, with end of treatment fat measurement as the dependent variable, dose of GWP42003 as regressor, baseline fat measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



23.  Secondary:   Change From Baseline to the End of Treatment in Mean Subcutaneous Abdominal Fat   [ Time Frame: After 56 days of treatment ]

Measure Type Secondary
Measure Title Change From Baseline to the End of Treatment in Mean Subcutaneous Abdominal Fat
Measure Description As measured by MRI/MRS scanning. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.
Time Frame After 56 days of treatment  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.

Reporting Groups
  Description
200 mg GWP42003 Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
400 mg GWP42003 Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
800 mg GWP42003 Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
Placebo Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.

Measured Values
    200 mg GWP42003     400 mg GWP42003     800 mg GWP42003     Placebo  
Number of Participants Analyzed  
[units: participants]
  7     6     6     5  
Change From Baseline to the End of Treatment in Mean Subcutaneous Abdominal Fat  
[units: litres]
Mean ± Standard Deviation
  1.24  ± 3.01     0.13  ± 0.21     -0.01  ± 0.57     -0.83  ± 2.19  


Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Subcutaneous Abdominal Fat
Groups [1] 200 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.077
Mean Difference (Final Values) [4] 2.31
Standard Error of the mean ± 1.229
90% Confidence Interval ( 0.17 to 4.44 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fat measurements were analysed using a linear regression model, with end of treatment fat measurement as the dependent variable, dose of GWP42003 as regressor, baseline fat measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Subcutaneous Abdominal Fat
Groups [1] 400 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.406
Mean Difference (Final Values) [4] 1.11
Standard Error of the mean ± 1.297
90% Confidence Interval ( -1.14 to 3.35 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fat measurements were analysed using a linear regression model, with end of treatment fat measurement as the dependent variable, dose of GWP42003 as regressor, baseline fat measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Subcutaneous Abdominal Fat
Groups [1] 800 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.532
Mean Difference (Final Values) [4] 0.83
Standard Error of the mean ± 1.299
90% Confidence Interval ( -1.42 to 3.08 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fat measurements were analysed using a linear regression model, with end of treatment fat measurement as the dependent variable, dose of GWP42003 as regressor, baseline fat measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



24.  Secondary:   Change From Baseline to the End of Treatment in Mean Total Abdominal Fat   [ Time Frame: After 56 days of treatment ]

Measure Type Secondary
Measure Title Change From Baseline to the End of Treatment in Mean Total Abdominal Fat
Measure Description As measured by MRI/MRS scanning. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.
Time Frame After 56 days of treatment  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.

Reporting Groups
  Description
200 mg GWP42003 Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
400 mg GWP42003 Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
800 mg GWP42003 Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
Placebo Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.

Measured Values
    200 mg GWP42003     400 mg GWP42003     800 mg GWP42003     Placebo  
Number of Participants Analyzed  
[units: participants]
  7     6     6     5  
Change From Baseline to the End of Treatment in Mean Total Abdominal Fat  
[units: litres]
Mean ± Standard Deviation
  1.44  ± 3.23     0.07  ± 0.40     0.24  ± 1.55     -1.60  ± 2.91  


Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Total Abdominal Fat
Groups [1] 200 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.025
Mean Difference (Final Values) [4] 3.45
Standard Error of the mean ± 1.415
90% Confidence Interval ( 1.00 to 5.91 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fat measurements were analysed using a linear regression model, with end of treatment fat measurement as the dependent variable, dose of GWP42003 as regressor, baseline fat measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Total Abdominal Fat
Groups [1] 400 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.165
Mean Difference (Final Values) [4] 2.20
Standard Error of the mean ± 1.522
90% Confidence Interval ( -0.44 to 4.84 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fat measurements were analysed using a linear regression model, with end of treatment fat measurement as the dependent variable, dose of GWP42003 as regressor, baseline fat measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Total Abdominal Fat
Groups [1] 800 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.194
Mean Difference (Final Values) [4] 2.04
Standard Error of the mean ± 1.514
90% Confidence Interval ( -0.58 to 4.67 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fat measurements were analysed using a linear regression model, with end of treatment fat measurement as the dependent variable, dose of GWP42003 as regressor, baseline fat measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



25.  Secondary:   Change From Baseline to the End of Treatment in Mean Internal Non-abdominal Fat   [ Time Frame: After 56 days of treatment ]

Measure Type Secondary
Measure Title Change From Baseline to the End of Treatment in Mean Internal Non-abdominal Fat
Measure Description As measured by MRI/MRS scanning. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.
Time Frame After 56 days of treatment  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.

Reporting Groups
  Description
200 mg GWP42003 Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
400 mg GWP42003 Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
800 mg GWP42003 Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
Placebo Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.

Measured Values
    200 mg GWP42003     400 mg GWP42003     800 mg GWP42003     Placebo  
Number of Participants Analyzed  
[units: participants]
  7     6     6     5  
Change From Baseline to the End of Treatment in Mean Internal Non-abdominal Fat  
[units: litres]
Mean ± Standard Deviation
  0.07  ± 0.42     0.06  ± 0.33     0.01  ± 0.64     -0.02  ± 0.75  


Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Internal Non-abdominal Fat
Groups [1] 200 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.700
Mean Difference (Final Values) [4] 0.13
Standard Error of the mean ± 0.325
90% Confidence Interval ( -0.44 to 0.69 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fat measurements were analysed using a linear regression model, with end of treatment fat measurement as the dependent variable, dose of GWP42003 as regressor, baseline fat measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Internal Non-abdominal Fat
Groups [1] 400 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.958
Mean Difference (Final Values) [4] 0.02
Standard Error of the mean ± 0.352
90% Confidence Interval ( -0.59 to 0.63 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fat measurements were analysed using a linear regression model, with end of treatment fat measurement as the dependent variable, dose of GWP42003 as regressor, baseline fat measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Internal Non-abdominal Fat
Groups [1] 800 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.777
Mean Difference (Final Values) [4] -0.10
Standard Error of the mean ± 0.356
90% Confidence Interval ( -0.72 to 0.52 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fat measurements were analysed using a linear regression model, with end of treatment fat measurement as the dependent variable, dose of GWP42003 as regressor, baseline fat measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



26.  Secondary:   Change From Baseline to the End of Treatment in Mean Subcutaneous Non-abdominal Fat   [ Time Frame: After 56 days of treatment ]

Measure Type Secondary
Measure Title Change From Baseline to the End of Treatment in Mean Subcutaneous Non-abdominal Fat
Measure Description As measured by MRI/MRS scanning. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.
Time Frame After 56 days of treatment  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.

Reporting Groups
  Description
200 mg GWP42003 Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
400 mg GWP42003 Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
800 mg GWP42003 Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
Placebo Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.

Measured Values
    200 mg GWP42003     400 mg GWP42003     800 mg GWP42003     Placebo  
Number of Participants Analyzed  
[units: participants]
  7     6     6     5  
Change From Baseline to the End of Treatment in Mean Subcutaneous Non-abdominal Fat  
[units: litres]
Mean ± Standard Deviation
  -0.74  ± 2.86     0.06  ± 0.46     0.13  ± 0.62     0.17  ± 1.65  


Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Subcutaneous Non-abdominal Fat
Groups [1] 200 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.409
Mean Difference (Final Values) [4] -0.86
Standard Error of the mean ± 1.018
90% Confidence Interval ( -2.63 to 0.90 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fat measurements were analysed using a linear regression model, with end of treatment fat measurement as the dependent variable, dose of GWP42003 as regressor, baseline fat measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Subcutaneous Non-abdominal Fat
Groups [1] 400 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.485
Mean Difference (Final Values) [4] -0.80
Standard Error of the mean ± 1.126
90% Confidence Interval ( -2.76 to 1.15 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fat measurements were analysed using a linear regression model, with end of treatment fat measurement as the dependent variable, dose of GWP42003 as regressor, baseline fat measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Subcutaneous Non-abdominal Fat
Groups [1] 800 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.429
Mean Difference (Final Values) [4] -0.94
Standard Error of the mean ± 1.165
90% Confidence Interval ( -2.96 to 1.08 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fat measurements were analysed using a linear regression model, with end of treatment fat measurement as the dependent variable, dose of GWP42003 as regressor, baseline fat measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



27.  Secondary:   Change From Baseline to the End of Treatment in Mean Total Non-abdominal Fat   [ Time Frame: After 56 days of treatment ]

Measure Type Secondary
Measure Title Change From Baseline to the End of Treatment in Mean Total Non-abdominal Fat
Measure Description As measured by MRI/MRS scanning. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.
Time Frame After 56 days of treatment  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.

Reporting Groups
  Description
200 mg GWP42003 Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
400 mg GWP42003 Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
800 mg GWP42003 Subjects self-administered four x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
Placebo Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.

Measured Values
    200 mg GWP42003     400 mg GWP42003     800 mg GWP42003     Placebo  
Number of Participants Analyzed  
[units: participants]
  7     6     6     5  
Change From Baseline to the End of Treatment in Mean Total Non-abdominal Fat  
[units: litres]
Mean ± Standard Deviation
  -0.67  ± 3.15     0.13  ± 0.75     0.15  ± 1.10     0.15  ± 2.29  


Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Total Non-abdominal Fat
Groups [1] 200 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.542
Mean Difference (Final Values) [4] -0.76
Standard Error of the mean ± 1.229
90% Confidence Interval ( -2.90 to 1.37 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fat measurements were analysed using a linear regression model, with end of treatment fat measurement as the dependent variable, dose of GWP42003 as regressor, baseline fat measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Total Non-abdominal Fat
Groups [1] 400 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.584
Mean Difference (Final Values) [4] -0.76
Standard Error of the mean ± 1.353
90% Confidence Interval ( -3.10 to 1.59 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fat measurements were analysed using a linear regression model, with end of treatment fat measurement as the dependent variable, dose of GWP42003 as regressor, baseline fat measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Total Non-abdominal Fat
Groups [1] 800 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.499
Mean Difference (Final Values) [4] -0.97
Standard Error of the mean ± 1.401
90% Confidence Interval ( -3.40 to 1.46 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fat measurements were analysed using a linear regression model, with end of treatment fat measurement as the dependent variable, dose of GWP42003 as regressor, baseline fat measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



28.  Secondary:   Change From Baseline to the End of Treatment in Mean Total Internal Fat   [ Time Frame: After 56 days of treatment ]

Measure Type Secondary
Measure Title Change From Baseline to the End of Treatment in Mean Total Internal Fat
Measure Description As measured by MRI/MRS scanning. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.
Time Frame After 56 days of treatment  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.

Reporting Groups
  Description
200 mg GWP42003 Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
400 mg GWP42003 Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
800 mg GWP42003 Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
Placebo Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.

Measured Values
    200 mg GWP42003     400 mg GWP42003     800 mg GWP42003     Placebo  
Number of Participants Analyzed  
[units: participants]
  7     6     6     5  
Change From Baseline to the End of Treatment in Mean Total Internal Fat  
[units: litres]
Mean ± Standard Deviation
  0.28  ± 0.65     0.01  ± 0.53     0.26  ± 1.69     -0.80  ± 2.61  


Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Total Internal Fat
Groups [1] 200 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.191
Mean Difference (Final Values) [4] 1.19
Standard Error of the mean ± 0.875
90% Confidence Interval ( -0.33 to 2.71 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fat measurements were analysed using a linear regression model, with end of treatment fat measurement as the dependent variable, dose of GWP42003 as regressor, baseline fat measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Total Internal Fat
Groups [1] 400 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.246
Mean Difference (Final Values) [4] 1.16
Standard Error of the mean ± 0.963
90% Confidence Interval ( -0.51 to 2.83 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fat measurements were analysed using a linear regression model, with end of treatment fat measurement as the dependent variable, dose of GWP42003 as regressor, baseline fat measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Total Internal Fat
Groups [1] 800 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.261
Mean Difference (Final Values) [4] 1.11
Standard Error of the mean ± 0.956
90% Confidence Interval ( -0.55 to 2.77 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fat measurements were analysed using a linear regression model, with end of treatment fat measurement as the dependent variable, dose of GWP42003 as regressor, baseline fat measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



29.  Secondary:   Change From Baseline to the End of Treatment in Mean Total Subcutaneous Fat   [ Time Frame: After 56 days of treatment ]

Measure Type Secondary
Measure Title Change From Baseline to the End of Treatment in Mean Total Subcutaneous Fat
Measure Description As measured by MRI/MRS scanning. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.
Time Frame After 56 days of treatment  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.

Reporting Groups
  Description
200 mg GWP42003 Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
400 mg GWP42003 Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
800 mg GWP42003 Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
Placebo Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.

Measured Values
    200 mg GWP42003     400 mg GWP42003     800 mg GWP42003     Placebo  
Number of Participants Analyzed  
[units: participants]
  7     6     6     5  
Change From Baseline to the End of Treatment in Mean Total Subcutaneous Fat  
[units: litres]
Mean ± Standard Deviation
  0.50  ± 0.54     0.19  ± 0.55     0.13  ± 0.93     -0.66  ± 2.58  


Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Total Subcutaneous Fat
Groups [1] 200 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.245
Mean Difference (Final Values) [4] 0.93
Standard Error of the mean ± 0.772
90% Confidence Interval ( -0.41 to 2.27 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fat measurements were analysed using a linear regression model, with end of treatment fat measurement as the dependent variable, dose of GWP42003 as regressor, baseline fat measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Total Subcutaneous Fat
Groups [1] 400 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.479
Mean Difference (Final Values) [4] 0.60
Standard Error of the mean ± 0.830
90% Confidence Interval ( -0.84 to 2.04 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fat measurements were analysed using a linear regression model, with end of treatment fat measurement as the dependent variable, dose of GWP42003 as regressor, baseline fat measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Total Subcutaneous Fat
Groups [1] 800 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.427
Mean Difference (Final Values) [4] 0.70
Standard Error of the mean ± 0.860
90% Confidence Interval ( -0.79 to 2.19 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fat measurements were analysed using a linear regression model, with end of treatment fat measurement as the dependent variable, dose of GWP42003 as regressor, baseline fat measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



30.  Secondary:   Change From Baseline to the End of Treatment in Mean Total Fat   [ Time Frame: After 56 days of treatment ]

Measure Type Secondary
Measure Title Change From Baseline to the End of Treatment in Mean Total Fat
Measure Description Total fat = total abdominal + total non-abdominal fat. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.
Time Frame After 56 days of treatment  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.

Reporting Groups
  Description
200 mg GWP42003 Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
400 mg GWP42003 Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
800 mg GWP42003 Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
Placebo Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.

Measured Values
    200 mg GWP42003     400 mg GWP42003     800 mg GWP42003     Placebo  
Number of Participants Analyzed  
[units: participants]
  7     6     6     5  
Change From Baseline to the End of Treatment in Mean Total Fat  
[units: litres]
Mean ± Standard Deviation
  0.78  ± 1.04     0.20  ± 1.02     0.39  ± 2.49     -1.46  ± 4.06  


Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Total Fat
Groups [1] 200 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.170
Mean Difference (Final Values) [4] 2.08
Standard Error of the mean ± 1.457
90% Confidence Interval ( -0.44 to 4.61 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fat measurements were analysed using a linear regression model, with end of treatment fat measurement as the dependent variable, dose of GWP42003 as regressor, baseline fat measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Total Fat
Groups [1] 400 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.351
Mean Difference (Final Values) [4] 1.50
Standard Error of the mean ± 1.564
90% Confidence Interval ( -1.21 to 4.21 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fat measurements were analysed using a linear regression model, with end of treatment fat measurement as the dependent variable, dose of GWP42003 as regressor, baseline fat measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Total Fat
Groups [1] 800 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.271
Mean Difference (Final Values) [4] 1.84
Standard Error of the mean ± 1.616
90% Confidence Interval ( -0.97 to 4.64 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fat measurements were analysed using a linear regression model, with end of treatment fat measurement as the dependent variable, dose of GWP42003 as regressor, baseline fat measurement as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



31.  Secondary:   Change From Baseline to the End of Treatment in Mean Abdominal Adiposity   [ Time Frame: After 56 days of treatment ]

Measure Type Secondary
Measure Title Change From Baseline to the End of Treatment in Mean Abdominal Adiposity
Measure Description Abdominal adiposity = ratio of total abdominal to total non-abdominal fat. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.
Time Frame After 56 days of treatment  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.

Reporting Groups
  Description
200 mg GWP42003 Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
400 mg GWP42003 Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
800 mg GWP42003 Subjects self-administered four x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
Placebo Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.

Measured Values
    200 mg GWP42003     400 mg GWP42003     800 mg GWP42003     Placebo  
Number of Participants Analyzed  
[units: participants]
  7     6     6     5  
Change From Baseline to the End of Treatment in Mean Abdominal Adiposity  
[units: ratio]
Mean ± Standard Deviation
  0.07  ± 0.21     -0.01  ± 0.03     0.02  ± 0.06     -0.12  ± 0.19  


Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Abdominal Adiposity
Groups [1] 200 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.019
Mean Difference (Final Values) [4] 0.19
Standard Error of the mean ± 0.074
90% Confidence Interval ( 0.06 to 0.32 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment visceral adiposity was analysed using a linear regression model, with end of treatment visceral adiposity as the dependent variable, dose of GWP42003 as regressor, baseline visceral adiposity as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Abdominal Adiposity
Groups [1] 400 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.035
Mean Difference (Final Values) [4] 0.19
Standard Error of the mean ± 0.082
90% Confidence Interval ( 0.04 to 0.33 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment visceral adiposity was analysed using a linear regression model, with end of treatment visceral adiposity as the dependent variable, dose of GWP42003 as regressor, baseline visceral adiposity as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Abdominal Adiposity
Groups [1] 800 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.027
Mean Difference (Final Values) [4] 0.19
Standard Error of the mean ± 0.081
90% Confidence Interval ( 0.05 to 0.34 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment visceral adiposity was analysed using a linear regression model, with end of treatment visceral adiposity as the dependent variable, dose of GWP42003 as regressor, baseline visceral adiposity as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



32.  Secondary:   Change From Baseline to the End of Treatment in Mean Total Fat as a Percentage of Body Weight   [ Time Frame: After 56 days of treatment ]

Measure Type Secondary
Measure Title Change From Baseline to the End of Treatment in Mean Total Fat as a Percentage of Body Weight
Measure Description A reduction from baseline (i.e. a negative value) in the amount of fat as a percentage of body weight indicates an improvement in condition.
Time Frame After 56 days of treatment  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.

Reporting Groups
  Description
200 mg GWP42003 Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
400 mg GWP42003 Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
800 mg GWP42003 Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
Placebo Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.

Measured Values
    200 mg GWP42003     400 mg GWP42003     800 mg GWP42003     Placebo  
Number of Participants Analyzed  
[units: participants]
  7     6     6     5  
Change From Baseline to the End of Treatment in Mean Total Fat as a Percentage of Body Weight  
[units: total fat as apercentage of body weight]
Mean ± Standard Deviation
  0.53  ± 0.87     -0.14  ± 1.12     0.76  ± 2.76     -1.27  ± 2.91  

No statistical analysis provided for Change From Baseline to the End of Treatment in Mean Total Fat as a Percentage of Body Weight



33.  Secondary:   Change From Baseline to the End of Treatment in Mean Fasting Serum Insulin   [ Time Frame: After 56 days of treatment ]

Measure Type Secondary
Measure Title Change From Baseline to the End of Treatment in Mean Fasting Serum Insulin
Measure Description A fasting blood sample was obtained for the measurement of fasting serum insulin. An increase from baseline (i.e. a positive value) indicates an improvement in condition.
Time Frame After 56 days of treatment  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
A reduction from baseline (i.e. a negative value) indicates an improvement in condition.

Reporting Groups
  Description
200 mg GWP42003 Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
400 mg GWP42003 Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
800 mg GWP42003 Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
Placebo Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.

Measured Values
    200 mg GWP42003     400 mg GWP42003     800 mg GWP42003     Placebo  
Number of Participants Analyzed  
[units: participants]
  7     6     7     5  
Change From Baseline to the End of Treatment in Mean Fasting Serum Insulin  
[units: pmol/l]
Mean ± Standard Deviation
  -29.40  ± 55.69     23.50  ± 45.91     -25.04  ± 51.98     -1.82  ± 26.90  


Statistical Analysis 1 for Change From Baseline to the End of Treatment in Mean Fasting Serum Insulin
Groups [1] 200 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.756
Mean Difference (Final Values) [4] 7.55
Standard Error of the mean ± 23.962
90% Confidence Interval ( -33.88 to 48.99 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fasting insulin levels were analysed using a linear regression model, with end of treatment fasting insulin levels as the dependent variable, dose of GWP42003 as regressor, baseline fasting insulin levels as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline to the End of Treatment in Mean Fasting Serum Insulin
Groups [1] 400 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.234
Mean Difference (Final Values) [4] 29.76
Standard Error of the mean ± 24.227
90% Confidence Interval ( -12.13 to 71.65 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fasting insulin levels were analysed using a linear regression model, with end of treatment fasting insulin levels as the dependent variable, dose of GWP42003 as regressor, baseline fasting insulin levels as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Change From Baseline to the End of Treatment in Mean Fasting Serum Insulin
Groups [1] 800 mg GWP42003 vs. Placebo
Method [2] Regression, Linear
P Value [3] 0.605
Mean Difference (Final Values) [4] -12.53
Standard Error of the mean ± 23.824
90% Confidence Interval ( -53.72 to 28.67 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  All statistical tests were two-sided at the 10% significance level. The null hypothesis was one of no difference in the effects of any of the three active treatments compared individually with placebo. The end of treatment fasting insulin levels were analysed using a linear regression model, with end of treatment fasting insulin levels as the dependent variable, dose of GWP42003 as regressor, baseline fasting insulin levels as a covariate, and gender as a factor.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



34.  Secondary:   Incidence of Adverse Events (AEs) as a Measure of Patient Safety   [ Time Frame: From 0 -10 weeks (study duration) ]

Measure Type Secondary
Measure Title Incidence of Adverse Events (AEs) as a Measure of Patient Safety
Measure Description All reported AEs were classified by system organ class (SOC), preferred term (PT) and low level term using version 13.1 of the MedDRA dictionary. The number of subjects who experienced an AE during the study is presented.
Time Frame From 0 -10 weeks (study duration)  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomised subjects were analysed.

Reporting Groups
  Description
200 mg GWP42003 Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
400 mg GWP42003 Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
800 mg GWP42003 Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
Placebo Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.

Measured Values
    200 mg GWP42003     400 mg GWP42003     800 mg GWP42003     Placebo  
Number of Participants Analyzed  
[units: participants]
  7     6     7     5  
Incidence of Adverse Events (AEs) as a Measure of Patient Safety  
[units: participants]
  6     5     7     5  

No statistical analysis provided for Incidence of Adverse Events (AEs) as a Measure of Patient Safety




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information