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Role of Exenatide in NASH-a Pilot Study | Clinical Trials | Clareo Health

COMPLETEDPHASE2/PHASE3

Role of Exenatide in NASH-a Pilot Study

Role of Exenatide in Treatment of NASH-a Pilot Study

NCT00650546•Indiana University

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.

Detailed Description

Eight adult patients with known type 2 DM(Diabetic) and biopsy-proven NAFLD were treated with 5-10 mcg subcutaneous exenatide for 28 weeks. Liver histology was assessed using the NAFLD Activity Score (NAS) prior to therapy and after 28 weeks of therapy. We used the following criteria to define our primary outcome: (i) no worsening of fibrosis score, (ii) improved score by at least one point in hepatocyte ballooning, (iii) either (a) improvement in NAS by 2 or more points spread across at least two of the three NAS components, or (b) post-treatment NAS equal or greater than 3.

Eligibility

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

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).
+7 more criteria

Locations (3)

Indiana University

Indianapolis, Indiana, United States

Kansas City VA Medical Center

Kansas City, Missouri, United States

Fort Sam Houston

San Antonio, Texas, United States

Key Dates

Start Date

August 1, 2006

Primary Completion Date

August 1, 2010

Completion Date

August 1, 2010

Last Updated

April 11, 2017

Enrollment

ACTUAL participants

Conditions

Nonalcoholic Fatty Liver Disease

Interventions

Exenatide

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 11, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Role of Exenatide in NASH-a Pilot Study

Inclusion Criteria

Exclusion Criteria

iWAIST Trial: ERCG (Endoscopic Radial Compression Gastroplasty) vs Optimized Lifestyle Intervention for Weight Loss

Phase 2b Study of GSK4532990 in Adults With NASH

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