NCT01284634

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

A Randomised, Partially-blind, Placebo-controlled, Pilot, Dose-ranging Study To Assess The Effect Of Cannabidiol (CBD) On Liver Fat Levels In Subjects With Fatty Liver Disease.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: GW Research Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effect of GWP42003 on liver triglyceride (liver fat) in participants with fatty liver disease (FLD).

Detailed description

This study was conducted as a 10-week (eight-week treatment period and one-week safety follow-up), randomized, partially-blind study that evaluated the effect of GWP42003 in participants with raised liver triglycerides (liver fat ≥5%). Participants were clinically diagnosed with FLD and had liver fat levels ≥5% as measured by Magnetic Resonance Imaging/ Magnetic Resonance Scanning (MRI/MRS), or were willing to undergo MRI/MRS scan at the screening visit to confirm a liver fat content of ≥5%. Eligible participants entered the study at a screening visit (Day -10 to -2) and then returned for a fasted baseline visit (Day 1), a mid-treatment visit (Day 29) and an end of treatment visit (Day 57). Safety follow-up telephone calls took place throughout the treatment period up to Day 64 after completion of treatment or seven days after date of last dose/withdrawal.

Conditions

• Fatty Liver

Interventions

Type	Name	Description
DRUG	GWP42003 200 mg/day Dose	GWP42003 was presented as Licaps® size double zero (Size 00) hard gelatin capsules containing 100 mg of CBD dissolved in vehicle (Gelucire 44/14).
DRUG	GWP42003 400 mg/day Dose	GWP42003 was presented as Licaps® Size 00 hard gelatin capsules containing 100 mg of CBD dissolved in vehicle (Gelucire 44/14).
DRUG	GWP42003 800 mg/day Dose	GWP42003 was presented as Licaps® Size 00 hard gelatin capsules containing 100 mg of CBD dissolved in vehicle (Gelucire 44/14).
DRUG	Placebo	Placebo was presented as Licaps® Size 00 hard gelatin capsules containing excipients (Gelucire 44/14).

Timeline

• Start date: 2011-05-03
• Primary completion: 2012-07-13
• Completion: 2012-07-13
• First posted: 2011-01-27
• Last updated: 2018-08-08
• Results posted: 2014-01-20

Locations

3 sites across 1 country: United Kingdom