GWMD09112 Dose Ranging Effects of CBD in Subjects with liver fat(NASH)

• Research type

  Research Study

• Full title

  A randomised, partially-blind, placebo-controlled, pilot, dose-ranging study to assess the effect of GWP42003 on liver fat levels in subjects with fatty liver disease.

• IRAS ID

  41068

• Contact name

  Jimmy Bell

• Sponsor organisation

  GW Pharmaceuticals Limited

• Eudract number

  2009-017080-41

• ISRCTN Number

  N/A

• Research summary

  The study is being conducted by GW Pharma Ltd as a pilot study in order to determine the efficacy and safety of Cannabidiol (CBD) alone at three different doses (200mg, 400mg, 800mg) in patients with non-alcoholic steatohepatitis (NASH). This is the first study to determine whether the study medication has a positive benefit for subjects on their liver fat content, body weight and other metabolic parameters. The main benefit to subjects in the study are likely to be in the areas of the amount of fat present in the subject's liver, which may be reduced as well as reducing the amount of total cholesterol (and increasing the "good" cholesterol (HDL cholesterol) and decreasing the amount of "bad" cholesterol (LDL cholesterol), as well as a reduction in triglyceride levels found in both plasma and the liver. In addition, they may lose some body fat. This study is being carried out at 2 centres in the UK and will involve a total of 24 people (3 groups of 8 subjects per treatment). This is an open-label dose-ranging randomised pilot study which will last for 10 weeks. There will be a total of 4 visits. NASH will be screened. If they are eligible, subjects will be sequentially allocated to increasing dose of the study medication for a total of 10 weeks, including a follow-up visit a week later. The primary endpoint will be assessed using MRI/MRS scan to determine levels of liver fat (NASH) in subjects enrolled. Plasma lipid levels will be determined. Food frequency questionnaires and physical activity questionnaires will be conducted to allow the investigator to make an opinion of whether the assessment outcome may affect the drug efficacy. Also, glucose control and insulin sensitivity and blood plasma cannabinoid levels will be measured. Other assessments include monitoring of adverse events, vital signs, blood/urine samples.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  10/H0406/7

• Date of REC Opinion

  26 Mar 2010

• REC opinion

  Further Information Favourable Opinion