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NCT Number: NCT06884293

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Overweight Body Weight Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD) Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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%

Exclusion criteria

  • 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

Treatment and study plan

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

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

Primary outcomes

  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

  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

    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

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

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

A Multicenter, Randomized, Open-label Phase III Study to Compare the Efficacy and Safety of IBI362 and Semaglutide in Chinese Overweight or Obese Subjects With Metabolic Dysfunction-associated Fatty Liver Disease (GLORY-3)

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 19, 2025
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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