Semaglutide Effects in Obese Youth With Prediabetes/New Onset Type 2 Diabetes and Metabolic Dysfunction-Associated Steatotic Liver Disease

What Was Tested

This registered phase 2 trial tested Semaglutide for fatty liver & elevated liver enzymes.

It had two arms (groups): Receive treatment (experimental) and Placebo (placebo comparator).

Semaglutide (Wegovy) pen is a subcutaneous injection.

The placebo pen is almost exactly the same as the Wegovy subcutaneous injection except it does not contain the active ingredient, Semaglutide.

The registry classes the interventions as drug.

Who Took Part

The registry lists 60 actual participants took part.

It was open to people of any sex aged from 10 years up to 21 years.

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

Examples of who could join: Weight ≥ 54kg. Ability and willingness to adhere to the protocol including self-measurement of plasma glucose according to the protocol.

The full record lists 8 inclusion and 23 exclusion criteria; among the exclusions: known or suspected hypersensitivity to trial product(s) or related products; receipt of any investigational medicinal product within 30 days before screening; prepubertal participants (tanner stage 1).

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

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

Groups ran in parallel: each of the fatty liver & elevated liver enzymes participants stayed in one arm throughout.

Blinding on both sides kept the fatty liver & elevated liver enzymes participants and researchers unaware of who received Semaglutide.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2023-07-17 with completion listed for 2026-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Oral Disposition Index (oDI) (time frame: Baseline and 6 months). Change in Protein Density Fat Fraction (PDFF) (time frame: Baseline and 6 months).

It also tracked 27 secondary outcomes, for example Change in Oral glucose tolerance test (OGTT) derived biomarkers: oDI, Change in OGTT derived biomarkers: fasting insulin, Change in OGTT derived biomarkers: fasting insulin, Change in OGTT derived biomarkers: c-peptide, Change in OGTT derived biomarkers: c-peptide and Change in OGTT derived biomarkers: fasting c-peptide.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 60 people with fatty liver & elevated liver enzymes.

Its status is active not 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.