A Study Comparing IBI362 vs Semaglutide in Chinese Overweight or Obese Adults With Metabolic Dysfunction-associated Fatty Liver Disease （MAFLD）

What Was Tested

This registered phase 3 trial tested Semaglutide and Mazdutide for fatty liver & elevated liver enzymes.

All study treatment will be administered once-weekly and subcutaneously.

It had two arms (groups): Semaglutide (active comparator) and IBI362 (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 479 actual participants took part.

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: Male or female, age 18 years or older at the time of signing informed consent.

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: subjects who the investigator thinks may be allergic to the components in the study drug or similar drugs; received chronic (\>2 weeks) systemic glucocorticoid treatment within 3 months before screening (excluding topical, intraocular, intranasal, and inhaled administration); previous diagnosis of type 1 diabetes (including adult latent autoimmune diabetes).

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The fatty liver & elevated liver enzymes participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

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

Nothing was hidden in this open-label Semaglutide study: the fatty liver & elevated liver enzymes participants and staff both knew the treatment.

It started in 2025-05-09 with completion listed for 2026-12-31.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: percentage change in body weight from baseline (time frame: at Week 48). percentage change in liver fat content from baseline measured by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) (time frame: at Week 48).

It also tracked 12 secondary outcomes, for example percentage change in liver fat content from baseline measured by MRI-PDFF, Absolute value change in liver fat content from baseline measured by MRI-PDFF, percentage change in body weight from baseline, Changes in systolic blood pressure and diastolic blood pressure from baseline, Changes in serum uric acid from baseline and Changes in hemoglobin A1c (HbA1c) from baseline.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide and Mazdutide in 479 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 and the Mazdutide compound page, Fatty liver & elevated liver enzymes research.