A Study of IBI362 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)

What Was Tested

The trial (phase 2) is built around Mazdutide.

The entire trial cycle includes a 8-week screening period, a 60-week double-blind treatment period, and a 4-week follow-up period.

It had three arms (groups): one (experimental), one (experimental) and Placebo (placebo comparator).

Placebo,SC,once a week for 60 weeks.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 165 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: Must be willing to participate in the study and provide written informed consent. Male or female, age 18 years or older at the time of signing informed consent. Body mass Index (BMI) ≥25 kg/m².

The full record lists 4 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; history or current other forms of chronic liver disease other than mash; patients with positive hepatitis b surface antigen (hbsag). patients with positive hbcab will be eligible only when hbv dna test negative at screening.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

The participants were allocated by chance, so the Mazdutide group and the comparison group should start out alike.

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

As a double-blind Mazdutide study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2025-07-01 with completion listed for 2026-04-30.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage of Participants With MASH resolution With no Worsening of Fibrosis on Liver Histology (time frame: Baseline, Week 60).

It also tracked 26 secondary outcomes, for example Mean Absolute Change and Percentage change From Baseline in aspartate aminotransferase[U/L], Mean Absolute Change and Percentage change From Baseline in alanine aminotransferase[U/L], Mean Absolute Change and Percentage change From Baseline in a γ-Glutamyl transferase[U/L], Mean Absolute Change and Percentage change From Baseline in triglyceride [mmol/L], Mean Absolute Change and Percentage change From Baseline in total cholesterol[mmol/L] and Mean Absolute Change and Percentage change From Baseline in low-density lipoprotein cholesterol[mmol/L].

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Mazdutide in 165 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Mazdutide compound page, all human trials.