METAfoie

Not yet recruitingPhase NA

Characterization and Management of Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD)

Characterization and Management of Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD) Through an Individualized Nutritionnal Approach and Semaglutide Therapy.

Lead sponsor

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Asset

Semaglutide

GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

120

Study population

MASH / NAFLD / liver fibrosis, Obesity / overweight

Eligibility highlights

•BMI 30-50

Primary endpoints

•Liver Steatosis•Liver stiffness (VCTE), change

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 IDNCT06764056

Org study ID2025-4271

Timeline

Milestones

Study first posted2025-01-08actual

Last update posted2025-01-08actual

Study start2025-01estimated (month precision)

Primary completion2026-05estimated (month precision)

Study completion2026-05estimated (month precision)

Assets

Investigational agents

Semaglutide

Who this study enrolls

MASH / NAFLD / liver fibrosisObesity / overweight

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Body mass index between 30 and 50 kg/m2;

•Stade 2 or 3 (S2 or S3) hepatic steatosis with or without liver fibrosis.

Exclusion criteria

•Type 1 diabetes diagnosis;

•Alcohol consumption exceeding recommendations [>140 g/week (women) and >210 g/week (men)];

•Known chronic hepatic disease non-steatotic at the entry of the study (Wilson's disease, hemochromatosis, alpha-1-antitrypsin deficiency, viral hepatitis, auto-immune hepatitis, etc.);

•Pharmacological treatment targeting obesity active or ended in the last 3 months;

•Bariatric surgery;

•Gastro-intestinal pathologies (GI cancers, IBD, etc.);

•Capsulated probiotics consumption;

•Antibiotic treatment in the last 3 months;

•Pregnancy;

•Cirrhosis diagnosis (hepatic decompensation).

Endpoints (13)

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

Glycemic / diabetes

Cardiometabolic biomarkers

Other (unclassified)

Glycemic / diabetes

3 endpoints

Secondary/protocol endpoint

Glucose

Time frame:From enrollment to the end of the clinical trial at 12 months (for 4 visits)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Insulin

Time frame:From enrollment to the end of the clinical trial at 12 months (for 4 visits)

concentration, descriptive

Secondary/protocol endpoint

Glycated hemoglobin

Time frame:From enrollment to the end of the clinical trial at 12 months (for 4 visits)

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

MASH / liver

6 endpoints

Primary/protocol endpoint

Liver Steatosis

Time frame:From enrollment to the end of the clinical trial at 12 months (for 4 visits)

categorical status, improvement

Primary/protocol endpoint

Liver Stiffness

Time frame:From enrollment to the end of the clinical trial at 12 months (for 4 visits)

Liver stiffness (VCTE), change

change from baseline, improvement

Secondary/protocol endpoint

Liver function (biochemistry)

Time frame:From enrollment to the end of the clinical trial at 12 months (for 4 visits)

descriptive, improvement

Secondary/protocol endpoint

Liver enzymes

Time frame:From enrollment to the end of the clinical trial at 12 months (for 4 visits)

change from baseline, improvement

Secondary/protocol endpoint

Fatty liver index (FLI)

Time frame:From enrollment to the end of the clinical trial at 12 months (for 4 visits)

threshold achievement, improvement

Secondary/protocol endpoint

Fibrosis-4 index (FIB-4)

Time frame:From enrollment to the end of the clinical trial at 12 months (for 4 visits)

threshold achievement, improvement

Cardiometabolic biomarkers

3 endpoints

Secondary/protocol endpoint

Lipid panel

Time frame:From enrollment to the end of the clinical trial at 12 months (for 4 visits)

descriptive, improvement

Secondary/protocol endpoint/low confidence

Change from Baseline in blood lipids and metabolites

Time frame:From enrollment to the end of the clinical trial at 12 months (for 4 visits)

change from baseline, improvement

Secondary/protocol endpoint

C-reactive protein

Time frame:From enrollment to the end of the clinical trial at 12 months (for 4 visits)

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Change from Baseline in the gut microbiota diversity

Time frame:From enrollment to the end of the clinical trial at 12 months (for 4 visits)

change from baseline, descriptive

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.