Clinical Trial

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

Active, Not Recruiting Phase 3
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Summary
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-03-17; most recent amendment 2026-05-11.
Status change: Recruiting → Active, Not Recruiting 2026-05-11
Status change: Not Yet Recruiting → Recruiting 2025-05-13
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 2025-05-09
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-12