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NCT06884293·Phase 3·INTERVENTIONAL

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

Status

Active, not recruiting

Phase

Phase 3

Enrollment

479

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

IBI362

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

DRUG

semaglutide

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

Timeline

From registration to results.

  1. First posted

    Mar 19, 2025

  2. Study start

    May 9, 2025

  3. Primary completion

    Dec 31, 2026

  4. Study completion

    Jun 30, 2027

  5. Results posted

    Not reported

  6. Registry updated

    May 12, 2026

Outcomes

What the study measures.

Primary outcomes

percentage change in body weight from baseline

Time frame · at Week 48

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

Time frame · at Week 48

Secondary outcomes

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

Time frame · at Week 8, 16, and 24

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

Time frame · at Week 8, 16, 24, and 48

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

Time frame · at week 48

percentage change in body weight from baseline

Time frame · at week 24

Changes in systolic blood pressure and diastolic blood pressure from baseline

Time frame · 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

Time frame · at week 48

Changes in serum uric acid from baseline

Time frame · at week 48

Changes in hemoglobin A1c (HbA1c) from baseline

Time frame · at week 48

Changes in Homeostasis Model Assessment 2-B (HOMA2-B) from baseline

Time frame · at week 48

Changes in Homeostasis Model Assessment 2-IR (HOMA2-IR) from baseline

Time frame · at week 48

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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 locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

Beijing Hospital

Beijing, Beijing Municipality, China

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Mazdutide.

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Put the record in context.

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