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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Secondary endpoints: 25 to 26v3 See this version in full on ClinicalTrials.gov ↗
  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of May 30, 2025 to Jul 1, 2025 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of May 30, 2025 to Jul 1, 2025
    • Site details revised
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06937749
Lead Sponsor Innovent Biologics (Suzhou) Co. Ltd.
Conditions Metabolic Dysfunction-associated Steatohepatitis (MASH)
Enrollment 165 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov