Role of Exenatide in NASH-a Pilot Study
Completed · Phase 2/Phase 3
Conditions studied: Nonalcoholic Fatty Liver Disease
In brief
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.
Key facts
- Study ID
- NCT00650546
- Run by
- Indiana University
- People needed
- 8
- Starts
- 2006-08-01
- Expected to finish
- 2010-08-01
- Last updated by the study team
- 2017-04-11
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Indiana University — Indianapolis, Indiana, United States
- Kansas City VA Medical Center — Kansas City, Missouri, United States
- Fort Sam Houston — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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