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Study to Evaluate the Effect of GWP42003 on Liver Fat Levels in Participants With Fatty Liver Disease

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ClinicalTrials.gov Identifier: NCT01284634
Recruitment Status : Completed
First Posted : January 27, 2011
Results First Posted : January 20, 2014
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
GW Research Ltd

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Fatty Liver
Interventions: Drug: GWP42003 200 mg/day Dose
Drug: GWP42003 400 mg/day Dose
Drug: GWP42003 800 mg/day Dose
Drug: Placebo

  Participant Flow

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
GWP42003 200 Milligram (mg)/Day Dose Participants self-administered one 100 mg GWP42003 capsule twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
GWP42003 400 mg/Day Dose Participants self-administered two x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
GWP42003 800 mg/Day Dose Participants self-administered four x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
Placebo Participants self-administered one, two or four placebo capsules twice daily, for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).

Participant Flow:   Overall Study
    GWP42003 200 Milligram (mg)/Day Dose   GWP42003 400 mg/Day Dose   GWP42003 800 mg/Day Dose   Placebo
STARTED   7   6   7   5 
Received at Least 1 Dose of Study Drug [1]   7   6   7   5 
Intent to Treat (ITT) Analysis Set [2]   7   6   7   5 
COMPLETED   6   6   5   4 
NOT COMPLETED   1   0   2   1 
Adverse Event                1                0                2                1 
[1] Safety analysis set; analyzed as per actual treatment received.
[2] Randomized and received at least one dose of study medication and had on-treatment efficacy data.



  Baseline Characteristics

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.
Safety Analysis Set: Participants who received at least 1 dose of investigational medicinal product (IMP); analyzed as per actual treatment received.

Reporting Groups
  Description
GWP42003 200 mg/Day Dose Participants self-administered one 100 mg GWP42003 capsule twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
GWP42003 400 mg/Day Dose Participants self-administered two x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
GWP42003 800 mg/Day Dose Participants self-administered four x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
Placebo Participants self-administered one, two or four placebo capsules twice daily, for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
Total Total of all reporting groups

Baseline Measures
   GWP42003 200 mg/Day Dose   GWP42003 400 mg/Day Dose   GWP42003 800 mg/Day Dose   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 7   6   7   5   25 
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) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      5  71.4%      2  33.3%      2  28.6%      4  80.0%      13  52.0% 
Male      2  28.6%      4  66.7%      5  71.4%      1  20.0%      12  48.0% 


  Outcome Measures

1.  Primary:   Percent Change From Baseline To The End Of Treatment (EOT) In Mean Liver Triglyceride Levels   [ Time Frame: Baseline to EOT (Day 57) or Early Termination (ET) ]

2.  Secondary:   Change From Baseline To The EOT In Mean Serum Total Cholesterol Levels   [ Time Frame: Baseline to EOT (Day 57) or ET ]

3.  Secondary:   Change From Baseline To The EOT In Mean Serum High Density Lipoprotein (HDL)-Cholesterol(C) Levels   [ Time Frame: Baseline to EOT (Day 57) or ET ]

4.  Secondary:   Change From Baseline To The EOT In Mean Serum Low-Density Lipoprotein (LDL)-C Levels   [ Time Frame: Baseline to EOT (Day 57) or ET ]

5.  Secondary:   Change From Baseline To The EOT In Mean Serum HDL: Low Density Lipoprotein (LDL)-Cholesterol (C) Ratio   [ Time Frame: Baseline to EOT (Day 57) or ET ]

6.  Secondary:   Change From Baseline To The EOT In Mean Serum Triglyceride Levels   [ Time Frame: Baseline to EOT (Day 57) or ET ]


  Serious Adverse Events


  Other Adverse Events


  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

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Enquires
Organization: GW Research Ltd
e-mail: medinfo@gwpharm.com, medinfo@greenwichbiosciences.com



Responsible Party: GW Research Ltd
ClinicalTrials.gov Identifier: NCT01284634     History of Changes
Other Study ID Numbers: GWMD09112
2009-017080-41 ( EudraCT Number )
First Submitted: January 26, 2011
First Posted: January 27, 2011
Results First Submitted: December 3, 2013
Results First Posted: January 20, 2014
Last Update Posted: August 8, 2018