CompletedPhase 4

Semaglutide in Nonalcoholic Fatty Liver Disease

Therapeutic Effect of Semaglutide on Nonalcoholic Fatty Liver Disease in Obesity and/or Type 2 Diabetes Mellitus

Lead sponsor

Zagazig University

Asset

Semaglutide

GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

180

Study population

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

Eligibility highlights

•BMI ≥30

Primary endpoint

•NAFLD regression

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05813249

Org study IDZU-IRB#10461/15-2-2023

Timeline

Milestones

Study start2023-02-15actual

Study first posted2023-04-14actual

Primary completion2024-02-15actual

Study completion2024-04-01actual

Last update posted2024-04-02actual

Assets

Investigational agents

Semaglutide

Who this study enrolls

MASH / NAFLD / liver fibrosisObesity / overweightType 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Patients diagnosed with NAFLD by non-invasive methods in the form of abdominal US or MRI, confirmed by a Fibroscan scan with CAP to assess the quantity of hepatic steatosis and severity of fibrosis up to 21 weeks before the start of the study and after treatment.

•Primary obesity with body mass index (BMI) > 30.

•Type 2 diabetes mellitus.

Exclusion criteria

•Type 1 diabetes mellitus.

•DM, which is treated with insulin glargine.

•Alcohol consumption.

•Patients had bariatric surgery.

•Hepatitis C virus, hepatitis B virus, HIV.

•Patients with peptic ulcer disease.

•Secondary obesity originated from hypothalamic or endocrinal disorders.

•Other causes of CLD.

•Decompensated liver disease.

•History of pancreatitis (acute or chronic).

•Hepato-biliary disorders.

•ALT and AST values > 5 times of upper normal limits.

•Severe cardiac disease.

•Patients treated with GLP-1 agonist within 90 days before screening.

•Patients with a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2).

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

NAFLD regression

Time frame:48 weeks

change from baseline, improvement

Secondary/protocol endpoint

Fibrosis regression

Time frame:48 weeks

Liver stiffness (VCTE), change

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

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 6, 2026 snapshot.