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

Last updated: May 11, 2026
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Overall Status: Active - Not Recruiting

Phase

3

Condition

Liver Disease

Obesity

Primary Biliary Cholangitis

Treatment

semaglutide

IBI362

Clinical Study ID

NCT06884293
CIBI362B303
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female, age 18 years or older at the time of signing informed consent

  2. diagnosed as MAFLD according to the Chinese Guideline for the prevention andtreatment of metabolic dysfunction-associated (non-alcoholic) fatty liver disease (Version 2024)

  3. liver fat content ≥8% measured by MRI-PDFF

  4. BMI≥27 kg/m2

  5. Weight change ≤5% within 3 months before screening

  6. HbA1c≤10%

Exclusion

Exclusion Criteria:

  1. Subjects who the investigator thinks may be allergic to the components in the studydrug or similar drugs

  2. Used drugs or alternative therapies with weight loss effects within 3 months beforescreening, including but not limited to: GLP-1 receptor agonists, orlistat,phenylpropanolamine, chlorpheniramine, phentermine etc.

  3. Received chronic (>2 weeks) systemic glucocorticoid treatment within 3 months beforescreening (excluding topical, intraocular, intranasal, and inhaled administration)

  4. Previous diagnosis of type 1 diabetes (including adult latent autoimmune diabetes)

  5. Active or untreated malignant tumors within 5 years before screening, or patientsare in remission of clinical malignant tumors (except patients with skin basal cellcarcinoma and squamous cell carcinoma, cervical carcinoma in situ, prostatecarcinoma in situ or papillary thyroid carcinoma who have no recurrence aftersurgery)

  6. Mental illness existed in the past or at the time of screening, and the researcherthinks it is not suitable to participate in this study

  7. Pregnant or lactating women, or men or women who are fertile and unwilling to usecontraception throughout the study period

Study Design

Total Participants: 479
Treatment Group(s): 2
Primary Treatment: semaglutide
Phase: 3
Study Start date:
May 09, 2025
Estimated Completion Date:
June 30, 2027

Connect with a study center

  • Beijing Hospital

    Beijing, Beijing Municipality 100730
    China

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.