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

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

Status: Not yet enrolling

Conditions: Metabolic Associated-dysfunction Steatohepatitis (MASH); Metabolic Associated Fatty Liver Disease; Obesity

Treatments: Other: Diet; Drug: semaglutide

Study type: Interventional

Funder types: Other

Identifiers

NCT06764056

2025-4271

Details and patient eligibility

About

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.

Full description

Participants in each group will be followed during a year for 4 timepoints (0, 3, 6 and 12 months). Blood and feces samples, anthropometric measures, transient elastography measurements and health questionnaires will be assessed at each timepoint.

The nutritionnal intervention targeting hepatic steastosis associated with obesity will use conclusions from a systematic review we conducted on nutritionnal approaches to treat liver steatosis.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

Nutrition

Active Comparator group

Description:

This arm will only participate in an individualized nutritionnal approach.

Treatment:

Other: Diet

Nutrition + Semaglutide

Active Comparator group

Description:

This arm will initiate a pharmacological intervention to treat obesity (Semaglutide) and will participate in an individualized nutritionnal approach.

Treatment:

Drug: semaglutide

Other: Diet

Semaglutide

Active Comparator group

Description:

This arm will only initiate a pharmacological intervention to treat obesity (Semaglutide)

Treatment:

Drug: semaglutide