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

Stopped early · Phase 2

Conditions studied: Diabetes Complications, Fatty Liver

In brief

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.

Key facts

Study ID

NCT00529204

Run by

University of California, Davis

People needed

1

Starts

2007-10-01

Expected to finish

2010-02-01

Last updated by the study team

2017-06-20

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California Davis Medical Center — Sacramento, California, United States

Full record on ClinicalTrials.gov

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