Effects Of Exenatide On Liver Biochemistry, Liver Histology And Lipid Metabolism In Patients With Fatty Liver Disease

• Status: Terminated
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) are common complications of type 2 diabetes and leading causes of liver disease in the US and Europe. The prevalence of NAFLD and NASH are expected to become a major cause of liver disease related deaths and liver transplantation. Currently, there are no specific therapies that alter the natural history of NAFLD.Preliminary evidence suggests that exenatide (Byetta®) may have several beneficial direct and indirect effects on NAFLD and liver lipid metabolism.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Davis
• Collaborators: Amylin Pharmaceuticals, LLC.; Eli Lilly and Company
• Treatments: Exenatide

Criteria

Inclusion Criteria:

• Age >18 years, < 70 years, inclusive

• Type 2 diabetes on stable doses of sulfonylurea and/or metformin

• Body mass index > 35 kg/m2

• Presumed diagnosis of NAFLD based upon

• an ALT > 1.5 times the upper limit of reference range,

• no evidence of other causes of liver disease and

• ultrasound findings compatible with fatty liver

Exclusion Criteria:

• Clinical signs of cirrhosis as evidenced by any of the following

• spider angiomata,

• splenomegaly,

• ascites

• jaundice

• encephalopathy

• INR > 1.2

• Platelet count < 100,000/ml

• Serum albumin < 3.0 g/dL

• Other liver disease including chronic viral hepatitis (B or C), alcohol abuse, hemochromatosis, alpha-1 antitrypsin deficiency, autoimmune hepatitis, Wilson's disease, primary sclerosing cholangitis or primary biliary cirrhosis.

• Current use of > 20 g of alcohol per day or unwillingness to avoid alcohol during the course of the study

• Treatment with a thiazolidinedione or exenatide within 6 months of enrolling in the study

• AST or ALT > 10 times the upper limit of normal

• Treatment with any investigational drug within 4 weeks of enrollment

• Pre-menopausal, fertile women unwilling to use contraceptives during the study period.

• Pregnancy or lactation

• Initiation or change in dose of hypolipidemic drugs (statins, niacin, cholestyramine are allowed) within 6 months of enrollment

• Use of anticoagulation, bleeding disorders or other contraindications to liver biopsy