GLP-1 Peptide Atlas, by Delfa

TerminatedPhase 2Results posted

Effects Of Exenatide On Liver Biochemistry, Liver Histology And Lipid Metabolism In Patients With Fatty Liver Disease

Effects Of Exenatide (Byetta®) On Liver Biochemistry, Liver Histology And Lipid Metabolism In Patients With Non-Alcoholic Fatty Liver Disease

Lead sponsor

University of California, Davis

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

MASH / NAFLD / liver fibrosis, Obesity / overweight, Type 2 diabetes

Key I/E criterion

•BMI ≥35

Primary endpoint

•ALT, change

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 IDNCT00529204

Org study ID200715325

Secondary IDH80-MC-X006UC Davis

Timeline

Milestones

Study first posted2007-09-14estimated

Results first posted2014-12-22estimated

Last update posted2017-06-20actual

Study start2007-10 (month precision)

Primary completion2009-07actual (month precision)

Study completion2010-02actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

MASH / NAFLD / liver fibrosisObesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Age >18 years, < 70 years, inclusive

•Type 2 diabetes on stable doses of sulfonylurea and/or metformin

•Body mass index > 35 kg/m2

•Presumed diagnosis of NAFLD based upon

•an ALT > 1.5 times the upper limit of reference range,

•no evidence of other causes of liver disease and

•ultrasound findings compatible with fatty liver

Exclusion criteria

•Clinical signs of cirrhosis as evidenced by any of the following

•spider angiomata,

•splenomegaly,

•ascites

•jaundice

•encephalopathy

•INR > 1.2

•Platelet count < 100,000/ml

•Serum albumin < 3.0 g/dL

•Other liver disease including chronic viral hepatitis (B or C), alcohol abuse, hemochromatosis, alpha-1 antitrypsin deficiency, autoimmune hepatitis, Wilson's disease, primary sclerosing cholangitis or primary biliary cirrhosis.

•Current use of > 20 g of alcohol per day or unwillingness to avoid alcohol during the course of the study

•Treatment with a thiazolidinedione or exenatide within 6 months of enrolling in the study

•AST or ALT > 10 times the upper limit of normal

•Treatment with any investigational drug within 4 weeks of enrollment

•Pre-menopausal, fertile women unwilling to use contraceptives during the study period.

•Pregnancy or lactation

•Initiation or change in dose of hypolipidemic drugs (statins, niacin, cholestyramine are allowed) within 6 months of enrollment

•Use of anticoagulation, bleeding disorders or other contraindications to liver biopsy

Endpoints (3)

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.

Coverage by outcome category

MASH / liver

Safety / tolerability / PK

MASH / liver

2 endpoints

Primary/protocol endpoint

Reduction in Serum ALT From Baseline to 24 Weeks of Exenatide Therapy

Time frame:24 weeks

ALT, change

change from baseline, improvement

LOINC 1742-6

Posted result

Group	Value (number), IU	95% CI
Exenatide	61	—

Secondary/protocol endpoint

Changes in Components of Liver Histology at Baseline and Week 24 Including Steatosis, Inflammation and Fibrosis

Time frame:24 weeks

change from baseline, improvement

Posted result

Group	Value (number), units on a scale	95% CI
Exenatidesteatosis	-1	—
inflammation	-1	—
fibrosis	0	—

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Safety of Exenatide in Patients With NAFLD and Type 2 Diabetes

Time frame:24 weeks

descriptive

Posted result

Group	Value (number), adverse events	95% CI
Exenatide	0	—

Publications (1)

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

Metabolic effects of two years of exenatide treatment on diabetes, obesity, and hepatic biomarkers in patients with type 2 diabetes: an interim analysis of data from the open-label, uncontrolled extension of three double-blind, placebo-controlled trials.
Clinical therapeutics2007 Jan (month)PMID17379054doi:10.1016/j.clinthera.2007.01.015via CT.gov background

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.