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

NCT06764056 | Not Yet Recruiting

• 1 other identifier: 2025-4271
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Obesity; Metabolic associated fatty liver disease; GLP-1 receptor analogs; Pharmacotherapy; Nutrition; Transient elastography; Semaglutide; Microbiome; Lipidomics

Outcome Measures

Primary Outcomes (2)

• Liver Steatosis

  Transient elastography is an ultrasound-based modality that is non-invasive and measures the degree of steatosis with the controlled attenuation parameter (CAP; dB/m) and liver stiffness (kPa).This method will be used at each visit to follow the progression and the efficiency of the interventions. The following ranges will be use to classify hepatic steatosis based on CAP (dB/m) (specific to FibroScan®): S0 (\< 302), S1 (302-331), S2 (331-337) and S3 (\>337).

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

• Liver Stiffness

  Transient elastography is an ultrasound-based modality that is non-invasive and measures the degree of steatosis with the controlled attenuation parameter (CAP; dB/m) and liver stiffness (kPa).This method will be used at each visit to follow the progression and the efficiency of the interventions. The following ranges will be use to classify hepatic fibrosis based on liver stiffness (kPa) (specific to FibroScan®): F0-F1 (\< 8.0), F2 (8.9-9.7), F3 (9.7-13.6) and F4 (\>13.6).

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

Secondary Outcomes (11)

• Liver function (biochemistry)

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

• Lipid panel

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

• Change from Baseline in the gut microbiota diversity

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

• Change from Baseline in blood lipids and metabolites

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

• Glucose

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

Study Arms (3)

Nutrition

ACTIVE COMPARATOR

This arm will only participate in an individualized nutritionnal approach.

Other: Diet

Nutrition + Semaglutide

ACTIVE COMPARATOR

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

Drug: semaglutide; Other: Diet

Semaglutide

ACTIVE COMPARATOR

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

Drug: semaglutide

Interventions

semaglutide DRUG

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.

Nutrition + Semaglutide; Semaglutide

Diet OTHER

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.

Also known as: Individualized nutritionnal intervention, Nutritionnal counselling

Nutrition; Nutrition + Semaglutide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index between 30 and 50 kg/m2;
• Stade 2 or 3 (S2 or S3) hepatic steatosis with or without liver fibrosis.

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Study Sites (1)

Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval

Québec, Quebec, G1V 4G5, Canada

Location

MeSH Terms

Conditions

Obesity

Interventions

semaglutide; Diet

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Fannie Lajeunesse-Trempe, MD., Ph.D.

  Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tristan Rocheleau, RD., M.Sc.

CONTACT

418-656-8711, #2681; tristan.rocheleau.2@ulaval.ca

Fannie Lajeunesse-Trempe, MD., Ph.D.

CONTACT

418-656-8711, #8052; fanny.lajeunesse-trempe.1@ulaval.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: January 8, 2025
• Study Start: January 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 8, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)