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

Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Study ID
NCT06884293
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD)
  • Overweight

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IBI362 — DRUG
    Once-weekly injections of gradually increased doses of IBI362, subcutaneously (SC): starting dose is 2.0 mg, after 4 weeks of administration, increase to 4.0 mg; After another 4 weeks, increase to 6mg; After another 4 weeks, increase to the maximum dose 9mg for 36 weeks
  • semaglutide — DRUG
    Once-weekly injections of gradually increased doses, subcutaneously (SC): starting dose is 0.25 mg, after 4 weeks of administration, increase to 0.5 mg; After another 4 weeks, increase to 1mg; After another 4 weeks, increase to 1.7mg; After another 4 weeks, increase to the maximum 2.5mg for 32 weeks

Study Details

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.

Key Dates

Start date
May 9, 2025
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
479 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Semaglutide
  • Experimental: IBI362

Primary Outcome Measure

percentage change in body weight from baseline [ Time Frame: at Week 48 ]

Related Studies