DelfaGLP-1 Atlas

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NAFLD

CompletedPhase 2, PHASE3Results posted

Role of Exenatide in NASH-a Pilot Study

Role of Exenatide in Treatment of NASH-a Pilot Study

Lead sponsor

Indiana University

Asset

Exenatide

GLP-1 agonist

Listed sites

3

Recruiting sites

—

Enrollment

8

actual

Study population

MASH / NAFLD / liver fibrosis, Type 2 diabetes

Key I/E criterion

—

Primary endpoints

•Improvement in Liver Histology After Treatment With Exenatide•NAS

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00650546
Org study IDDK61737
Secondary IDU01DK061737

Timeline

Milestones

Study first posted2008-04-01estimated
Results first posted2016-05-12estimated
Last update posted2017-04-11actual
Study start2006-08 (month precision)
Primary completion2010-08actual (month precision)
Study completion2010-08actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

MASH / NAFLD / liver fibrosisType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age99 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

MASH / liver

2 endpoints
Primary/protocol endpoint

Number of Patients With Improvement in Liver Histology After Treatment With Exenatide

Time frame:between baseline and 24-28 weeks after initiating treatment

threshold achievement, improvement

Posted result

GroupValue (number), participants95% CI
Treatment With Exenatide8—
Primary/protocol endpoint/low confidence

Change in NAS

Time frame:Between baseline and 28 weeks of treatment with exenatide, sub q, 5-10 mcq.

change from baseline, improvement

Posted result

GroupValue (mean), units on a scale95% CI
Individuals Who Recieved Treatment With Exenatide-1.5—

Publications (11)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.