CClinicalTrials.gg
Sign In
Active, not recruitingNCT06884293Updated May 12, 2026

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

A Phase 3 interventional study of IBI362 and semaglutide in Overweight and Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD), sponsored by Innovent Biologics (Suzhou) Co. Ltd.. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-12.

Sponsored by Innovent Biologics (Suzhou) Co. Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
479
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Overweight
  • Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD)

Browse trials for

03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's enrollment of 479 is above the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd. is the lead sponsor of 192 studies on the registry; 44 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
479 participants (actual)

Study arms

  • Active comparator
    Semaglutide

    Drug: semaglutide

  • Experimental
    IBI362

    Drug: IBI362

Interventions

  • DrugIBI362

    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

  • Drugsemaglutide

    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

06

What researchers measure

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

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

    Time frame: at week 48

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

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

    Time frame: at week 48

07

Study locations

1 site
  • Beijing Hospital
    Beijing, Beijing Municipality 100730, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06884293
Lead sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Responsible party
Sponsor
First posted
Mar 19, 2025
Start date
May 9, 2025
Primary completion
Dec 31, 2026 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
May 12, 2026

Study contacts

Lixin Guo, M.D
principal investigator · Beijing Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Overweight→

Other studies from this sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Start the discussion