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

What Was Tested

The trial (not phased) is built around Semaglutide for fatty liver & elevated liver enzymes.

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.

It had three arms (groups): Nutrition (active comparator), Nutrition + Semaglutide (active comparator) and Semaglutide (active comparator).

This arm will only participate in an individualized nutritionnal approach.

The registry classes the interventions as drug and other.

More on the Plan

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.

Who Took Part

The registry lists 120 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Body mass index between 30 and 50 kg/m2;. Stade 2 or 3 (S2 or S3) hepatic steatosis with or without liver fibrosis.

The full record lists 2 inclusion and 10 exclusion criteria; among the exclusions: type 1 diabetes diagnosis;; 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.);; bariatric surgery;.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

The Semaglutide group and the comparison group ran side by side rather than switching.

Being open-label, the Semaglutide study did not mask who received what.

It started in 2025-01 with completion listed for 2026-05.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Liver Steatosis (time frame: From enrollment to the end of the clinical trial at 12 months (for 4 visits)). Liver Stiffness (time frame: From enrollment to the end of the clinical trial at 12 months (for 4 visits)).

It also tracked 11 secondary outcomes, for example Liver function (biochemistry), Lipid panel, Change from Baseline in the gut microbiota diversity, Change from Baseline in blood lipids and metabolites, Glucose and Insulin.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Semaglutide in 120 people with fatty liver & elevated liver enzymes.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, Fatty liver & elevated liver enzymes research.