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

NCT06937749 · Recruiting

Last updated 2026-05-28

This clinical trial is testing the drug IBI362 in adults with metabolic dysfunction-associated steatohepatitis (MASH) to see if it can improve liver health without worsening scarring.

Status Recruiting Currently enrolling participants.

Phase Phase 2 Tests whether it works and watches safety in a moderate group.

Type Interventional (clinical trial)

Design Randomized, triple-blind treatment study

Participants 165 people Planned (estimated).

Who can join Ages 18+ · all sexes

Timeline Started 2025-07 · est. completion 2027-07

Where 1 site · China

What this study is testing ClinicalTrials.gov NCT06937749 ↗

Description as written by the study sponsor.

This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical study evaluating the efficacy and safety of IBI362 in MASH subjects. Subjects will be randomly assigned to IBI362 low-dose, high-dose and placebo groups. The entire trial cycle includes a 8-week screening period, a 60-week double-blind treatment period, and a 4-week follow-up period.

Treatments tested

Placebo Drug

Placebo administered subcutaneously (SC) once a week.
IBI362 Drug

IBI362 administered subcutaneously (SC) once a week.

Main thing measured	Percentage of Participants With MASH resolution With no Worsening of Fibrosis on Liver Histology
Sponsor	Innovent Biologics (Suzhou) Co. Ltd.
Conditions studied	Metabolic Dysfunction-associated Steatohepatitis (MASH)
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06937749 ↗