Phase 2 and Phase 3 · Exenatide

NAFLD trial results

Role of Exenatide in Treatment of NASH-a Pilot Study

Participants
8
Status
completed
Completed
2010-08
Sponsor
Indiana University

As posted on ClinicalTrials.gov (NCT00650546), updated at source Apr 11, 2017. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NAFLD measured first

Number of Patients With Improvement in Liver Histology After Treatment With Exenatideparticipants · between baseline and 24-28 weeks after initiating treatment · number
Treatment With Exenatiden=8
8
Change in NASunits on a scale · Between baseline and 28 weeks of treatment with exenatide, sub q, 5-10 mcq. · mean
Individuals Who Recieved Treatment With Exenatiden=8
-1.5(1.66)
Side effects by arm

Side effects in NAFLD

Percent of participants affected, 28 weeks. The most common events the registry lists.

EventExenatide Group
Any serious event0%
abdominal pain along with nausea25%
The trial

How NAFLD was run

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.

  • A pre treatment NAS score: liver biopsy score pre treatment with exenatide 5 micrograms SQ (sub-cutaneous) twice a day titrated to 10 mcg SQ twice a day as tolerated
Who could join the trial

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.

Published papers

Papers from NAFLD

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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