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

NCT06764056 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-01-08

No results posted yet for this study

Summary

The goal of this clinical trial is to improve the treatment of hepatic steatosis associated with obesity with pharmacological and nutritionnal approaches. The main question it aims to answer is:

Does an individualized nutritionnal approach with a dietician combined with medication targeting obesity is the most efficient way to treat hepatic steatosis associated with obesity?

Participants will either participate in one of three groups:

* Nutrition: Participant will only have a regular follow-up with a registered dietician;
* Nutrition + Semaglutide: Participants will start a new medication targeting obesity and will have a regular follow-up with a registered dietician;
* Semaglutide: Participants will start a new medication targeting obesity.

Conditions

  • Metabolic Associated Fatty Liver Disease
  • Metabolic Associated-dysfunction Steatohepatitis (MASH)
  • Obesity

Interventions

DRUG

semaglutide

Participants receiving this intervention will be starting with a dose of semaglutide 0.25 mg. Physicians will follow Wegovy® Dosing Schedule guidelines, ending with a final dose of 2.4 mg at the fifth month. Type 2 diabetes participants wishing to stop at 1.0 mg will be allowed.

OTHER

Diet

Participants receiving this intervention will be seeing a registered dietician at each visit. The individualized approach will be based on recent literature (mostly hypocaloric) by using different methods.

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Fannie Lajeunesse-Trempe, MD., Ph.D. · Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-31
Primary Completion
2026-05-31
Completion
2026-05-31

Countries

  • Canada

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06764056 on ClinicalTrials.gov