A Study Comparing IBI362 vs Semaglutide in Chinese Overweight or Obese Adults With Metabolic Dysfunction-associated Fatty Liver Disease （MAFLD）
- Status
- Active not recruitingResults none
- Why it is watched
- non-weight indication: liver
- Who it enrolls
- age 18 Years to no upper limit; excludes diabetes; BMI ≥27 required; conditions: Overweight; Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD)
- Interventions
- IBI362; semaglutide
- Conditions
- Overweight; Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD)
- Phase and size
- Phase 3 · 479 participants
- Dates
- Start 2025-05-09
Primary completion 2026-12-31 - Sponsor
- Innovent Biologics (Suzhou) Co. Ltd. (Industry)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- percentage change in body weight from baselineat Week 48
- percentage change in liver fat content from baseline measured by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF)at Week 48
02Eligibility
Who can take part
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 and treatment 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 Criteria: 1. Subjects who the investigator thinks may be allergic to the components in the study drug or similar drugs 2. Used drugs or alternative therapies with weight loss effects within 3 months before screening, 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 before screening (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 patients are in remission of clinical malignant tumors (except patients with skin basal cell carcinoma and squamous cell carcinoma, cervical carcinoma in situ, prostate carcinoma in situ or papillary thyroid carcinoma who have no recurrence after surgery) 6. Mental illness existed in the past or at the time of screening, and the researcher thinks it is not suitable to participate in this study 7. Pregnant or lactating women, or men or women who are fertile and unwilling to use contraception throughout the study period
03Change log
Registry changes
No changes recorded since the trial was added.