Study to Evaluate the Effect of GWP42003 on Liver Fat Levels in Participants With Fatty Liver Disease
Condition: Fatty Liver
MeSH terms: Liver Diseases; Fatty Liver
Intervention: GWP42003 200 mg/day Dose; GWP42003 400 mg/day Dose; GWP42003 800 mg/day Dose; Placebo
Intervention description: GWP42003 was presented as Licaps® size double zero (Size 00) hard gelatin capsules containing 100 mg of CBD dissolved in vehicle (Gelucire 44/14).; GWP42003 was presented as Licaps® Size 00 hard gelatin capsules containing 100 mg of CBD dissolved in vehicle (Gelucire 44/14).; GWP42003 was presented as Licaps® Size 00 hard gelatin capsules containing 100 mg of CBD dissolved in vehicle (Gelucire 44/14).; Placebo was presented as Licaps® Size 00 hard gelatin capsules containing excipients (Gelucire 44/14).
Intervention MeSH terms: Cannabidiol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: This study was partially-blinded. Due to the varying numbers of capsules administered, participants and investigators were not blinded to the treatment cohort (one, two or four capsules), but were blinded to the treatment allocation within each cohort (GWP42003 or placebo)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cannabidiol; Fatty liver; Diabetes; Body fat

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).
    

Eligibility 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.