GLP1_NAFLD

CompletedResults posted

The Effect of GLP-1 Analogues on Liver Steatosis and Fibrosis in Diabetic and Obese Patients in a Clinical Setting

Lead sponsor

Universitair Ziekenhuis Brussel

Asset

GLP-1 / incretin class catch-all

Listed sites

Recruiting sites

Actual enrollment

Study population

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

Eligibility highlights

Primary endpoints

•Serum Markers (sfG) to Follow the Evolution of Liver Damage•Fatty Liver Index (FLI)•FIB-4 Index

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 IDNCT07021443

Org study IDGLP1_NAFLD

Timeline

Milestones

Study start2023-10-09actual

Primary completion2023-10-26actual

Study completion2025-05-12actual

Study first posted2025-06-15actual

Last update posted2025-08-26actual

Results first posted2025-08-26actual

Assets

Investigational agents

GLP-1 / incretin class catch-all

Who this study enrolls

MASH / NAFLD / liver fibrosisObesity / overweightType 2 diabetes

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Sampling methodNon probability sample

Study population text

Participants will be recruited from consultations in the diabetes- and obesity clinic in UZ Brussel. All diabetic and/or obese patients with objectified NAFLD starting a GLP-1 analogue, or whom have started a GLP-1 analogue 12 months prior, will be considered as possible candidates. Inclu-sion is definite after it is established that patients comply to all inclusion- and exclusion criteria and they agree to the informed consent.

Inclusion criteria

•The patient is older than 18 years old.

•The patient has obesity, defined as a BMI of 30 or higher; and/or the patient suffers from T2DM, defined as a twice measured sfG of 125 mg/dl or higher, or a sfG of 100 to 125 mg/dl and a twice measured oral glucose tolerance test (OGTT) with a serum glucose (sG) of 200 mg/dl, or higher after 2 hours, or a random sG of 200 mg/dl or higher in symptomatic patients.

•The patient suffers from NAFLD in any stage, except cirrhosis. This has to be objec-tively diagnosed by either a CAP fibroscan (cutoff: > 238 dB/m); or by the calculated NAFLD liver fat score (cutoff: > -0,64), at least one of which has to be positive.

•The patient is starting a GLP-1 analogue as treatment for T2DM or obesity as would be prescribed outside of this study; or the patient has started a GLP-1 analogue as treatment for T2DM or obesity as would be prescribed outside of this study 12 months prior.

•If the patient is part of the retro-prospective branch data collected 12 months prior include at least a (CAP) fibroscan, a blood sample (measuring AST, ALT, GGT, sfG, sfI, HbA1c, HDL, LDL, total cholesterol and platelets) and a physical examination (measuring blood pressure, waist circumference, weight and length).

Exclusion criteria

•The patient suffers from alcohol induced fatty liver disease. Macrocytic anemia; de-creased vitamin B12 and folic acid; increased GGT, bilirubin, ferritin, TG and AST/ALT ratio can be used as serum markers of alcohol abuse. Interpretation of these results will be the left to the patient's clinician and their clinical expertise. Alterna-tively a weekly alcohol consumption of 21 units for men and 14 units for women can be used as a cutoff.

•The patient suffers from drug induced liver steatosis. Drugs warranting exclusion include glucocorticoids, amiodarone, tamoxifen, methotrexate, valproate, tetracycline and chemotherapeutic agents.

•The patient suffers from any other chronic liver disease. These will be checked trough lab test results in the patients file.

•The patient has liver cirrhosis, defined as a fibroscan score of 14 kPa or more; or a FIB-4 index of > 2,67. Elastography

•The patient is pregnant at time of enrolment or at any time during the study.

•The patient refuses to agree to the informed consent.

Endpoints (4)

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

Other (unclassified)

Glycemic / diabetes

1 endpoint

Primary/protocol endpoint

Serum Markers (HbA1c) to Follow the Evolution of Liver Damage

Time frame:From time of infomed consent till 1 year after signing informed consent.

descriptive

Other (unclassified)

3 endpoints

Primary/protocol endpoint/low confidence

Serum Markers (sfG) to Follow the Evolution of Liver Damage

Time frame:From time of infomed consent till 1 year after signing informed consent.

descriptive

Primary/protocol endpoint/low confidence

Fatty Liver Index (FLI)

Time frame:From time of signing the ICF till 1 year after given informed consent

descriptive

Primary/protocol endpoint/low confidence

FIB-4 Index

Time frame:From time of signing the ICF till 1 year after given informed consent

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.