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

NCT01284634 | Completed Phase 2 Results

• 2 other identifiers: GWMD091122009-017080-41
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 3

Brief 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).

Conditions

Fatty Liver

Keywords

Cannabidiol; Fatty liver; Diabetes; Body fat

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline To The End Of Treatment (EOT) In Mean Liver Triglyceride Levels

  Liver triglyceride levels were measured by Magnetic Resonance Imaging/Magnetic Resonance Scanning and the percent change from baseline to EOT in group mean levels was investigated. A reduction from baseline, that is, a negative value, indicates an improvement in condition.

  Baseline to EOT (Day 57) or Early Termination (ET)

Secondary Outcomes (5)

• Change From Baseline To The EOT In Mean Serum Total Cholesterol Levels

  Baseline to EOT (Day 57) or ET

• Change From Baseline To The EOT In Mean Serum High Density Lipoprotein (HDL)-Cholesterol(C) Levels

  Baseline to EOT (Day 57) or ET

• Change From Baseline To The EOT In Mean Serum Low-Density Lipoprotein (LDL)-C Levels

  Baseline to EOT (Day 57) or ET

• Change From Baseline To The EOT In Mean Serum HDL: Low Density Lipoprotein (LDL)-Cholesterol (C) Ratio

  Baseline to EOT (Day 57) or ET

• Change From Baseline To The EOT In Mean Serum Triglyceride Levels

  Baseline to EOT (Day 57) or ET

Study Arms (4)

GWP42003 200 milligrams (mg)/day Dose

EXPERIMENTAL

Participants self-administered one x 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 \[typically 12 hours apart\]).

Drug: GWP42003 200 mg/day Dose

GWP42003 400 mg/day Dose

EXPERIMENTAL

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 \[typically 12 hours apart\]).

Drug: GWP42003 400 mg/day Dose

GWP42003 800 mg/day Dose

EXPERIMENTAL

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 \[typically 12 hours apart\]).

Drug: GWP42003 800 mg/day Dose

Placebo

EXPERIMENTAL

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 \[typically 12 hours apart\]). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste.

Drug: Placebo

Interventions

GWP42003 200 mg/day Dose DRUG

GWP42003 was presented as Licaps® size double zero (Size 00) hard gelatin capsules containing 100 mg of CBD dissolved in vehicle (Gelucire 44/14).

Also known as: Cannabidiol, CBD

GWP42003 200 milligrams (mg)/day Dose

GWP42003 400 mg/day Dose DRUG

GWP42003 was presented as Licaps® Size 00 hard gelatin capsules containing 100 mg of CBD dissolved in vehicle (Gelucire 44/14).

Also known as: Cannabidiol, CBD

GWP42003 400 mg/day Dose

GWP42003 800 mg/day Dose DRUG

GWP42003 was presented as Licaps® Size 00 hard gelatin capsules containing 100 mg of CBD dissolved in vehicle (Gelucire 44/14).

Also known as: Cannabidiol, CBD

GWP42003 800 mg/day Dose

Placebo DRUG

Placebo was presented as Licaps® Size 00 hard gelatin capsules containing excipients (Gelucire 44/14).

Also known as: Placebo control

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GW Research Ltd: lead

Study Sites (3)

Unknown Facility

London, W120NN, United Kingdom

Location

Unknown Facility

Manchester, M13 9WL, United Kingdom

Location

Unknown Facility

Manchester, M32 0UT, United Kingdom

Location

MeSH Terms

Conditions

Fatty Liver; Diabetes Mellitus

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Medical Enquires
• Organization: GW Research Ltd

medinfo@gwpharm.com, medinfo@greenwichbiosciences.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2011
• First Posted: January 27, 2011
• Study Start: May 3, 2011
• Primary Completion: July 13, 2012
• Study Completion: July 13, 2012
• Last Updated: August 8, 2018
• Results First Posted: January 20, 2014

Record last verified: 2018-07

Locations

GB (3)