NCT06937749

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 165 (estimated)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metabolic Dysfunction-associated Steatohepatitis (MASH)

Interventions

Type	Name	Description
DRUG	Placebo	Placebo administered subcutaneously (SC) once a week.
DRUG	IBI362	IBI362 administered subcutaneously (SC) once a week.

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-04-30
• Completion: 2027-07-22
• First posted: 2025-04-22
• Last updated: 2025-11-20

Locations

1 site across 1 country: China