Overview

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

Status:
Completed
Trial end date:
2012-07-13
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
GW Research Ltd
Treatments:
Cannabidiol
Criteria
Inclusion Criteria:

- Participant gave informed consent for participation in the study.

- Participant was aged 18 years or above.

- Participant had documented evidence of liver fat content ≥5% as measured by MRI/MRS
scanning or a biopsy within two months prior to screening, or willing to undergo an
MRI/MRS scan at Visit 1 (Day -10 to -2) to confirm a liver fat content of ≥5%.

- Participant had, in the opinion of the investigator, no changes in levels of exercise
or diet for four weeks (as assessed by the physical activity questionnaire and food
frequency questionnaire) prior to the start of treatment, and participant agreed to
keep stable for the duration of the study.

- Participant was able (in the investigator's opinion) and willing to comply with all
study requirements.

- Participant was willing for his or her name to be notified to the responsible
authorities for participation in this study, as applicable.

- Participant was willing to allow his or her primary care practitioner and consultant,
if appropriate, to be notified of participation in the study.

Exclusion Criteria:

- Participant had clinical diagnosis or treatment for Type I/II diabetes.

- Participant had received an unapproved investigational medicinal product (IMP) within
the 30 days prior to the screening visit.

- Participant was receiving a prohibited medication and unwilling to stop for 14 days
prior to the screening visit and for the duration of the study.

- Participant was using or had used recreational cannabis, medicinal cannabis, or
cannabinoid medications (including Sativex) within one month prior to study entry and
unwilling to abstain for the duration of the study.

- Participant had any known or suspected history of alcohol or substance abuse, or
epilepsy or recurrent seizures.

- Participant had any known or suspected history of major depression sufficient to
require treatment or disrupt ordinary life (excluding episodes of reactive depression,
in the opinion of the investigator).

- Participant had clinically significant cardiac, renal, or hepatic impairment, in the
opinion of the investigator.

- Participant had known history of Hepatitis B or C.

- Participant had genetic dyslipidaemia, in the opinion of the Investigator.

- Participant had any other significant disease or disorder which, in the opinion of the
investigator, may either put the participant at risk because of participation in the
study, influence the result of the study, or affect the participant's ability to
participate in the study.

- Participant had any known or suspected hypersensitivity to cannabinoids or any of the
excipients of the IMP(s).

- Participant had presence of any metal implants.

- Participant had any known or suspected history of claustrophobia.

- Female participants of child bearing potential not able or willing to use effective
contraception for the duration of the study and for three months thereafter, or male
participants whose partner was of child bearing potential, who was not willing to
ensure that they or their partner would use effective contraception during the study
and for three months thereafter.

- Female participant who was pregnant, lactating or planning pregnancy during the course
of the study and for three months thereafter.

- Participants who weighed >150 kilograms (kg).

- Participant had any abnormalities following a physical examination that, in the
opinion of the investigator, prevented the participant from safe participation in the
study.

- Participant was unwilling to abstain from donation of blood during the study.

- Participant had planned travel outside the country of residence during the study.

- Participant had previously enrolled into this study.