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

Fatty Liver Clinical Trial

Official title:
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.

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01284634
Study type Interventional
Source GW Research Ltd
Contact
Status Completed
Phase Phase 2
Start date May 3, 2011
Completion date July 13, 2012
View Details
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