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

Sponsor
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Study ID
NCT06764056
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Jan 31, 2025
Status verified
Dec 2024
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Nutrition
    This arm will only participate in an individualized nutritionnal approach.
  • Active Comparator: Nutrition + Semaglutide
    This arm will initiate a pharmacological intervention to treat obesity (Semaglutide) and will participate in an individualized nutritionnal approach.
  • Active Comparator: Semaglutide
    This arm will only initiate a pharmacological intervention to treat obesity (Semaglutide)

Primary Outcome Measure

Liver Steatosis [ Time Frame: From enrollment to the end of the clinical trial at 12 months (for 4 visits) ]

Central Contacts

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