Comparing IBI362 and Semaglutide for treating overweight adults with fatty liver disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 clinical study is a multicenter, randomized, open-label trial that evaluates the efficacy and safety of IBI362 compared to Semaglutide in overweight or obese adults diagnosed with metabolic dysfunction-associated fatty liver disease (MAFLD). Participants will be randomly assigned to receive either IBI362 9 mg or Semaglutide 2.4 mg, both administered subcutaneously once a week. The study includes a 4-week screening period, a 48-week treatment phase, and a 12-week follow-up for safety assessment after drug withdrawal.

Why it matters

Who can join: the full rules

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

Where it's running

• Beijing Hospital
  Beijing, Beijing, China Recruiting

Study contacts

• Principal investigator: Lixin Guo, M.D — Beijing Hospital
• Study coordinator: lixin guo
• Email: glx1218@163.com
• Phone: 13901317569

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.