Subjects with fatty liver disease (= 5% liver fat levels). MedDRA version: 13.1 Level: LLT Classification code 10029530 Term: Non-alcoholic fatty liver System Organ Class: 10019805 - Hepatobiliary disorders
Conditions
Interventions
Product Name: GW42003 Capsule
Product Code: EN0017
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Not Applicable
CAS Number: 13
Sponsors
GW Pharma Ltd.
Eligibility
Sex/Gender
All
Inclusion 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 a liver fat content of equal to or above 5% as measured by MRI/MRS or biopsy within two months of screening or willing to undergo an MRI/MRS scan at Visit 1to 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 Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 21 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
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 for the study • Any known or suspected history of: - alcohol or substance abuse - epilepsy or recurrent seizures • 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) • 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.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary efficacy endpoints are: • Fasting lipid profile (serum Total Cholesterol, serum HDL Cholesterol levels, serum HDL / LDL ratio, serum triglycerides) • Body weight & BMI • Adipose tissue distribution (body fat content, visceral adiposity, waist circumference, waist-to-hip ratio, neck circumference and skin fold thickness) • Glucose control (fasting plasma glucose levels) • Insulin sensitivity (fasting serum insulin levels) Safety and tolerability assessments. ;Timepoint(s) of evaluation of this end point: Day 57 (End of week 8 for safety and tolerability, follow up at day 64 week 9) | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of cannabidiol (CBD) on liver triglyceride levels (liver fat) in subjects with fatty liver disease.;Primary end point(s): Liver triglyceride levels (liver fat) after 8 weeks of treatment.;Timepoint(s) of evaluation of this end point: Day 57 (End of week 8); Secondary Objective: To assess the effect of CBD on: • Lipid profile (serum Total Cholesterol, serum High-density lipoprotein (HDL), Cholesterol levels, serum HDL / Low density lipoprotein (LDL) ratio, serum triglycerides) • Body weight & Body Mass Index (BMI) • Adipose tissue distribution (body fat content, visceral adiposity, waist circumference, waist-to-hip ratio, neck circumference and skin fold thickness) • Glucose control (fasting plasma glucose levels) • Insulin sensitivity (fasting serum insulin levels) •The variables for proof of exposure to CBD (the change from baseline to end of treatment in plasma CBD levels) To assess the safety and tolerability of CBD. | — |
Countries
United Kingdom
Contacts
Public ContactGW Pharma Ltd. Switchboard
GW Pharma Ltd.
Outcome results
None listed