Overview

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