Clinical Trial

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

Recruiting Phase 2
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Record status
This record was last updated November 20, 2025 (before its estimated April 30, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-04-17; most recent amendment 2025-11-17.
Status change: Not Yet Recruiting → Recruiting 2025-07-22
Trial Details
NCT Number NCT06937749
Lead Sponsor Innovent Biologics (Suzhou) Co. Ltd.
Conditions Metabolic Dysfunction-associated Steatohepatitis (MASH)
Enrollment 165 participants
Start Date 2025-07-01
Primary Completion 2026-04-30 (estimated)
Study Completion 2027-07-22 (estimated)
Updated on ClinicalTrials.gov 2025-11-20