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A Study Comparing IBI362 vs Semaglutide in Chinese Overweight or Obese Adults With Metabolic Dysfunction-associated Fatty Liver Disease （MAFLD）

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 470 to confirmed 479 · Site details revisedv3 Show 2 more changesShow less
    • Enrollment target: estimated 470 to confirmed 479
    • Site details revised
  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Mar 31, 2025 to May 9, 2025 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of Mar 31, 2025 to May 9, 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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, open-label Phase 3 clinical study comparing the efficacy and safety of IBI362 9 mg QW versus Semaglutide 2.4 mg QW in overweight or obese (BMI≥27kg/m2) MAFLD subjects. Subjects will be randomly assigned to IBI362 9 mg and Semaglutide 2.4 mg groups. All study treatment will be administered once-weekly and subcutaneously. The entire trial cycle includes a 4-week screening period, a 48-week open-label treatment period, and a 12-week drug withdrawal safety follow-up period.
Trial Details
NCT Number NCT06884293
Lead Sponsor Innovent Biologics (Suzhou) Co. Ltd.
Conditions Overweight, Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD)
Enrollment 479 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov