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

Phase 3

Recruiting

• Conditions: Overweight; Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD)
• Interventions: Drug: semaglutide; Drug: IBI362

• Registration Number: NCT06884293
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-11
• Study First Submitted QC: 2025-03-17
• Study First Posted: 2025-03-19
• Status Verified: 2025-05
• Study Start: 2025-05-09
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-14
• Primary Completion: 2026-12-31
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 470

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Semaglutide	semaglutide	-
IBI362	IBI362	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
percentage changes in total cholesterol,triglyceride (TG), non-High Density Lipoprotein Cholesterol (non-HDL-C), Low Density Lipoprotein Cholesterol (LDL-C), HDL-C (High Density Lipoprotein Cholesterol) from baseline	at week 48
Changes in serum uric acid from baseline	at week 48
Changes in hemoglobin A1c (HbA1c) from baseline	at week 48
Changes in Homeostasis Model Assessment 2-B (HOMA2-B) from baseline	at week 48
Changes in Homeostasis Model Assessment 2-IR (HOMA2-IR) from baseline	at week 48
Changes of scores in 36-item Short-Form Health Survey version 2(SF-36v2) questionnaire from baseline	at week 48	Using norm-based scoring (NBS)，each subscale has a different maximum and minimum score, with higher scores reflecting better levels of functioning
Changes of scores in The Impact of Weight on Quality of Life-Lite Clinical Trials Version(IWQoL-Lite-CT) questionnaire from baseline	at week 48	Total score ranging from 0 to 100, with higher scores reflecting better levels of functioning

Trial Locations

Locations (1)

Beijing Hospital; 🇨🇳 Beijing, Beijing, China