Non-alcoholic fatty liver disease (NAFLD) - Clinical trial details 

Recruitment status:

Not recruiting

Primary Sponsor:

GW Research Ltd

Recruitment countries:

United Kingdom

Health condition studied:

Fatty Liver

URL:

Link to the clinical trial website

About the trial

Interventions:

Drug: Cannabidiol

Key inclusion and exclusion criteria:

• 
  Inclusion Criteria:
  
  - Subject is willing and able to give informed consent for participation in the study.
  
  - Subject is aged 18 years or above.
  
  - Subjects with documented evidence of liver fat content equal to or above 5% as
  measured by MRI/MRS or a biopsy within two months, or willing to undergo MRI/MRS scan
  at Visit 1 to confirm a liver fat content of equal to or above 5%.
  
  - In the opinion of the investigator, no changes in levels of exercise for four weeks
  and diet (as assessed by the physical activity questionnaire and food frequency
  questionnaire) prior to the start of treatment and subject agrees to keep stable for
  the duration of the study.
  
  - Subject is able (in the investigator's opinion), and willing to comply with all study
  requirements.
  
  - Subject is willing for his or her name to be notified to the responsible authorities
  for participation in this study, as applicable.
  
  - Subject is willing to allow his or her primary care practitioner and consultant, if
  appropriate, to be notified of participation in the study.
  
  Exclusion Criteria:
  
  - Clinical diagnosis or treatment for Type I/II diabetes.
  
  - Subject has received an unapproved IMP within the 30 days prior to the screening
  visit.
  
  - Currently receiving a prohibited medication and unwilling to stop for 14 days prior
  to the screening visit and for the duration of the study.
  
  - Currently using or has 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.
  
  - Any known or suspected history of: alcohol or substance abuse epilepsy or recurrent
  seizures.
  
  - Any know 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).
  
  - Clinically significant cardiac, renal or hepatic impairment in the opinion of the
  investigator.
  
  - Known history of Hepatitis B or C.
  
  - Genetic dyslipidaemia in the opinion of the investigator.
  
  - Any other significant disease or disorder which, in the opinion of the investigator,
  may either put the subject at risk because of participation in the study, may
  influence the result of the study, or the subject's ability to participate in the
  study.
  
  - Any known or suspected hypersensitivity to cannabinoids or any of the excipients of
  the IMP(s).
  
  - Presence of any metal implants.
  
  - Any known or suspected history of claustrophobia.
  
  - Female subjects 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
  subjects whose partner is of child bearing potential, who are not willing to ensure
  that they or their partner use effective contraception during the study and for three
  months thereafter.
  
  - Female subject who is pregnant, lactating or planning pregnancy during the course of
  the study and for three months thereafter.
  
  - Weighing >150 kg.
  
  - Following a physical examination, the subject has any abnormalities that, in the
  opinion of the investigator would prevent the subject from safe participation in the
  study.
  
  - Unwilling to abstain from donation of blood during the study.
  
  - Travel outside the country of residence planned during the study.
  
  - Subject has previously enrolled into this study.
  

• Age minimum:  18 Years
• Age maximum:  N/A
• Gender:  Both

Primary outcomes:

Change From Baseline to the End of Treatment in Mean % Liver Triglyceride Levels

Secondary outcomes:

Change From Baseline to the End of Treatment in Mean Abdominal Adiposity
Change From Baseline to the End of Treatment in Mean Body Mass Index (BMI)
Change From Baseline to the End of Treatment in Mean Body Weight
Change From Baseline to the End of Treatment in Mean Fasting Plasma Glucose Levels
Change From Baseline to the End of Treatment in Mean Fasting Serum Insulin
Change From Baseline to the End of Treatment in Mean Hip Measurement
Change From Baseline to the End of Treatment in Mean Internal Non-abdominal Fat
Change From Baseline to the End of Treatment in Mean Neck Measurement
Change From Baseline to the End of Treatment in Mean Serum High Density Lipoprotein (HDL)-Cholesterol(C) Levels
Change From Baseline to the End of Treatment in Mean Serum Low Density Lipoprotein (LDL)-Cholesterol(C) Levels
Change From Baseline to the End of Treatment in Mean Serum Triglyceride Levels
Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Abdomen)
Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Chest/Pectoral)
Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Midaxillary)
Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Subscapular)
Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Suprailiac)
Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Thigh)
Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Triceps)
Change From Baseline to the End of Treatment in Mean Subcutaneous Abdominal Fat
Change From Baseline to the End of Treatment in Mean Subcutaneous Non-abdominal Fat
Change From Baseline to the End of Treatment in Mean Total Abdominal Fat
Change From Baseline to the End of Treatment in Mean Total Fat
Change From Baseline to the End of Treatment in Mean Total Fat as a Percentage of Body Weight
Change From Baseline to the End of Treatment in Mean Total Internal Fat
Change From Baseline to the End of Treatment in Mean Total Non-abdominal Fat
Change From Baseline to the End of Treatment in Mean Total Skin-fold Thickness
Change From Baseline to the End of Treatment in Mean Total Subcutaneous Fat
Change From Baseline to the End of Treatment in Mean Visceral Abdominal Fat
Change From Baseline to the End of Treatment in Mean Waist Measurement
Change From Baseline to the End of Treatment in Mean Waist-to-hip Ratio
Change From Baseline to the End of Treatment it Mean Serum Total Cholesterol Levels
Change From Baseline to the End of Treatment it the Mean Serum HDL:LDL Cholesterol Ratio
Incidence of Adverse Events (AEs) as a Measure of Patient Safety

Target sample size:

25

Study type:

Interventional

Study design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Contacts:

• Name:   Anthony P Goldstone, BM BCh,MRCP,PhD
• Address: 
• Phone: 
• Email: 
• Affiliation:  Imperial College Healthcare NHS Trust

Technical details

Scientific title:

A Randomised, Partially-blind, Placebo-controlled, Pilot, Dose-ranging Study to Assess the Effect of Cannabidiol on Liver Fat Levels in Subjects With Fatty Liver Disease

Sources of monetary support:

Please refer to primary and secondary sponsors

Secondary sponsors:

Main ID:

NCT01284634

Secondary ID:

2009-017080-41
GWMD09112

Register:

ClinicalTrials.gov

Date of registration:

26/01/2011

Date of first enrollment:

February 2011

Last refreshed:

19 February 2015