Liraglutide Efficacy and Action in Non-Alcoholic Steatohepatitis

• Research type

  Research Study

• Full title

  A 48-WEEK PHASE II, RANDOMISED, DOUBLE BLINDED PLACEBO CONTROLLED, PARALLEL-GROUP, MULTI-CENTRE TRIAL ON LIRAGLUTIDE’S SAFETY, EFFICACY AND ACTION ON LIVER HISTOLOGY AND METABOLISM IN OVERWEIGHT PATIENTS WITH NON-ALCOHOLIC STEATOHEPATITIS, WITH OR WITHOUT TYPE II DIABETES

• IRAS ID

  48451

• Contact name

  Philip Newsome

• Eudract number

  2009-016761-29

• ISRCTN Number

  ISRCTN85774727

• Research summary

  Non-alcoholic fatty liver disease (NAFLD) is the commonest cause of liver disease in the western world. Simple fatty liver (steatosis) is generally regarded as harmless, but for an increasing number of people overtime the fat in the liver progresses into a more advanced inflammatory and scarring condition known as Non-Alcoholic Steatohepatitis (NASH). NASH is related to obesity, high blood pressure, high levels of blood fats and type 2 diabetes. Whilst weight loss and improvements in sugar control may decrease the amount of fat accumulated in the liver of diabetics, there are currently no drug therapies that impact on the natural disease progression of NASH. A number of multinational human studies have shown that a new once-daily drug, called liraglutide (a synthetic form of the hormone Glucagon-like Peptide 1), achieves better blood sugar control blood and promotes weight loss in people with type 2 diabetes, and more recently in non-diabetic people. This study is the first of its kind to assess the use of liraglutide as a treatment option in NASH. This study aims to investigate the effect that Liraglutide has on liver damage in overweight patients with NASH in England and Germany. Fifty patients who have a diagnosis of NASH on liver biopsy preceding the study will be randomised to receive either Liraglutide (experiment drug) or control (a non-active liraglutide placebo) treatment for 48 weeks. At the end of the treatment period a study liver biopsy will allow researchers to assess whether liraglutide has had a beneficial effect on liver disease. Investigating changes in weight, blood pressure, blood sugar, cholesterol, insulin sensitivity, and blood markers of liver scarring and inflammation throughout the trial, will aid with determining the mechanisms by which liraglutide may be exerting an effect in such liver patients.

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  10/H0402/32

• Date of REC Opinion

  14 May 2010

• REC opinion

  Further Information Favourable Opinion