Role of Exenatide in NASH-a Pilot Study

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.