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RECRUITING
NCT06937749
PHASE2

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

Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

View on ClinicalTrials.gov

Summary

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.

Official title: A Randomized, Double-blind, Placebo-controlled Phase 2 Study Evaluating the Efficacy and Safety of IBI362 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

165

Start Date

2025-07-01

Completion Date

2027-07-22

Last Updated

2025-11-20

Healthy Volunteers

No

Interventions

DRUG

Placebo

Placebo administered subcutaneously (SC) once a week.

DRUG

IBI362

IBI362 administered subcutaneously (SC) once a week.

Locations (1)

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, China