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OverweightPhase 3NCT06884293

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

A Phase 3 study testing IBI362 and semaglutide in people with Overweight and Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD), run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
IBI362 and semaglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
479 participants
Where
1 siteChina
Study dates
9 May 2025to 30 Jun 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Hospital

    Beijing, Beijing Municipality, 100730

Other trials in China

About this study

Official 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)

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.

Being tested
IBI362, semaglutide
Medical subject headings
Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IBI362Drug

    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

  • semaglutideDrug

    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

Study groups in NCT06884293
Study groupRoleWhat they receive
SemaglutideActive comparatorNot described
Receives: Drug: semaglutide
IBI362ExperimentalNot described
Receives: Drug: IBI362

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. percentage change in body weight from baseline

    Measured: at Week 48

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

    Measured: at Week 48

Secondary outcomes (12)

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

    Measured: at Week 8, 16, and 24

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

    Measured: at Week 8, 16, 24, and 48

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

    Measured: at week 48

  4. percentage change in body weight from baseline

    Measured: at week 24

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

    Measured: 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

    Measured: at week 48

  7. Changes in serum uric acid from baseline

    Measured: at week 48

  8. Changes in hemoglobin A1c (HbA1c) from baseline

    Measured: at week 48

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

    Measured: at week 48

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

    Measured: 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

    Measured: 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

    Measured: at week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2025
  2. Study start9 May 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
479 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06884293
Sponsor's protocol ID
CIBI362B303
Status last verified
May 2026
First submitted
11 Mar 2025
Last updated
12 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing IBI362 and semaglutide in people with Overweight and Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD), run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

percentage change in body weight from baseline (time frame: at Week 48). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06884293.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.

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