Role of Exenatide in NASH-a Pilot Study (NAFLD)

Inclusion Criteria:

• Well documented NASH based on clinical and histological criteria. Liver biopsy must have been obtained within 12-months prior to initiation of the study.
• Subjects must have known diabetes (either diet controlled or only on Metformin or sulfonylureas such as glyburide or glipizide).
• Subjects must be 18 year or older.

Exclusion Criteria:

• Co-existing etiologies for chronic liver disease (hepatitis B or C, autoimmune or hemochromatosis, etc.).
• Clinical or histological evidence of cirrhosis.
• Alanine aminotransferase or aspartate aminotransferase > 300 IU/L.
• Uncontrolled diabetes (hemoglobin A1C greater than or equal to 9%).
• Insulin or TZD dependant DM.
• Known human immunodeficiency virus infection.
• Current or history of significant alcohol consumption within past 5 years. Significant alcohol consumption is defined as >20 grm/day in females and >30 grms/day in males or if alcohol consumption cannot satisfactorily be quantified.
• Serum creatinine of greater than or equal to 2 mg/dl.
• Active, serious medical disease (cardiac, renal, pulmonary, dermatologic, psychiatric illness) with likely life expectancy less 5 years.
• Current or previous malignancy with expected life expectancy less than 5-years (other than basal cell cancer of the skin).
• Use of drugs historically associated with NASH.
• Histological evidence of malignancy, 4+ iron deposition, or any other type of liver disease.
• Active substance abuse, such as alcohol,inhaled or injection drugs with the previous one year.
• Known intolerance or allergy to exenatide (Byetta).
• History of neuroglycopenia.
• Women of childbearing potential must have had a negative pregnancy test prior to starting the study and should be willing to avoid pregnancy during the study period.
• Women must not be nursing.