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Trial · Interventional

Active, not recruitingPhase 3Registry data

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

NCTNCT06884293 (opens ClinicalTrials.gov in a new tab)Other idCIBI362B303
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Active, not recruiting
Phase
Phase 3
Enrollment
479 participants (actual)
Sponsor
Innovent Biologics (Suzhou) Co. Ltd. · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

China

Start
9 May 2025
Primary completion
31 Dec 2026 (estimated)
Completion
30 Jun 2027 (estimated)
First posted
19 Mar 2025
Last update posted
12 May 2026
Conditions
Overweight · Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD)

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2025202620272028
  1. Ph 3

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

    NCT06884293

    9 May 2025 to est. 30 Jun 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • IBI362Drug
  • semaglutideDrug

Arms2

  • Active comparator

    Semaglutide

  • Experimental

    IBI362

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. percentage change in body weight from baseline

    Time frame · at Week 48

  2. 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(12)

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

    Time frame · at Week 8, 16, and 24

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

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

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

    Time frame · at week 48

  4. percentage change in body weight from baseline

    Time frame · at week 24

  5. Changes in systolic blood pressure and diastolic blood pressure from baseline

    Time frame · at week 48

  6. 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

  7. Changes in serum uric acid from baseline

    Time frame · at week 48

  8. Changes in hemoglobin A1c (HbA1c) from baseline

    Time frame · at week 48

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

    Time frame · at week 48

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

    Time frame · at week 48

  11. Changes of scores in 36-item Short-Form Health Survey version 2(SF-36v2) questionnaire from baseline

    Time frame · at week 48

    Registry description

    Using norm-based scoring (NBS)，each subscale has a different maximum and minimum score, with higher scores reflecting better levels of functioning

  12. Changes of scores in The Impact of Weight on Quality of Life-Lite Clinical Trials Version(IWQoL-Lite-CT) questionnaire from baseline

    Time frame · at week 48

    Registry description

    Total score ranging from 0 to 100, with higher scores reflecting better levels of functioning

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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