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 2, 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 ]

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

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 ]

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 ]

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 ]

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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 ]

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

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

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

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

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

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

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

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

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

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

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 ]

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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