Role of Exenatide in NASH-a Pilot Study

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

Summary

We hypothesize that exenatide (Byetta), a GLP-1 agonist administered subcutaneously for 24-28 weeks improves liver histology in diabetic patients with biopsy-proven NASH.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indiana University
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Exenatide

Criteria

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.