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

NCT06884293 | Recruiting Phase 3

• 1 other identifier: CIBI362B303
• Study Type: interventional
• Target: 470
• Locations: 1 country
• Sites: 1

Brief 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)

Outcome Measures

Primary Outcomes (2)

• percentage change in body weight from baseline

  at Week 48

• percentage change in liver fat content from baseline measured by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF)

  at Week 48

Secondary Outcomes (12)

• percentage change in liver fat content from baseline measured by MRI-PDFF

  at Week 8, 16, and 24

• Absolute value change in liver fat content from baseline measured by MRI-PDFF

  at Week 8, 16, 24, and 48

• Proportion of subjects with weight loss >10% from baseline and liver fat content <5%

  at week 48

• percentage change in body weight from baseline

  at week 24

• Changes in systolic blood pressure and diastolic blood pressure from baseline

  at week 48

Study Arms (2)

Semaglutide

ACTIVE COMPARATOR

Drug: semaglutide

IBI362

EXPERIMENTAL

Drug: IBI362

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

IBI362

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

Semaglutide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age 18 years or older at the time of signing informed consent
• diagnosed as MAFLD according to the Chinese Guideline for the prevention and treatment of metabolic dysfunction-associated (non-alcoholic) fatty liver disease (Version 2024)
• liver fat content ≥8% measured by MRI-PDFF
• BMI≥27 kg/m2
• Weight change ≤5% within 3 months before screening
• HbA1c≤10%

You may not qualify if:

• Subjects who the investigator thinks may be allergic to the components in the study drug or similar drugs
• 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.
• Received chronic (\>2 weeks) systemic glucocorticoid treatment within 3 months before screening (excluding topical, intraocular, intranasal, and inhaled administration)
• Previous diagnosis of type 1 diabetes (including adult latent autoimmune diabetes)
• 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)
• 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
• Pregnant or lactating women, or men or women who are fertile and unwilling to use contraception throughout the study period

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Overweight

Interventions

mazdutide; semaglutide

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lixin Guo, M.D

  Beijing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

lixin guo

CONTACT

13901317569; glx1218@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 19, 2025
• Study Start: May 9, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)