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

NCT06884293 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 479

Last updated 2026-05-12

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

IBI362

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

DRUG

semaglutide

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

Sponsors & Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Lixin Guo, M.D · Beijing Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-09
Primary Completion
2026-12-31
Completion
2027-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06884293 on ClinicalTrials.gov