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A Study Comparing IBI362 vs Semaglutide in Chinese Overweight or Obese Adults With Metabolic Dysfunction-associated Fatty Liver Disease （MAFLD）
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)
Lead sponsor
Assets
Mazdutide / Semaglutide
Listed sites
1
Recruiting sites
—
Enrollment
479
actual
Study population
MASH / NAFLD / liver fibrosis, Obesity / overweight
Key I/E criteria
•BMI ≥27•HbA1c ≤10%
Primary endpoints
•Body weight, % change•Liver fat content, change
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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
Endpoints (14)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
2 endpointspercentage change in body weight from baseline
Time frame:at Week 48
Body weight, % change
percent change from baseline, improvement
percentage change in body weight from baseline
Time frame:at week 24
Body weight, % change
percent change from baseline, improvement
Glycemic / diabetes
3 endpointsChanges in hemoglobin A1c (HbA1c) from baseline
Time frame:at week 48
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Changes in Homeostasis Model Assessment 2-B (HOMA2-B) from baseline
Time frame:at week 48
change from baseline, improvement
Changes in Homeostasis Model Assessment 2-IR (HOMA2-IR) from baseline
Time frame:at week 48
HOMA-IR (insulin sensitivity)
change from baseline, improvement
MASH / liver
4 endpointspercentage change in liver fat content from baseline measured by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF)
Time frame:at Week 48
Liver fat content, change
percent change from baseline, improvement
percentage change in liver fat content from baseline measured by MRI-PDFF
Time frame:at Week 8, 16, and 24
Liver fat content, change
percent change from baseline, improvement
Absolute value change in liver fat content from baseline measured by MRI-PDFF
Time frame:at Week 8, 16, 24, and 48
Liver fat content, change
change from baseline, improvement
Proportion of subjects with weight loss >10% from baseline and liver fat content <5%
Time frame:at week 48
threshold achievement, improvement
components≥10% weight-loss responders, Liver fat content, change
Cardiometabolic biomarkers
2 endpointsChanges in systolic blood pressure and diastolic blood pressure from baseline
Time frame:at week 48
Systolic BP, change
change from baseline, improvement
LOINC 8480-6
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
percent change from baseline, improvement
componentsTotal cholesterol, change, Triglycerides, change, Non-HDL cholesterol, change, LDL-C, change, HDL-C, change
Patient-reported / QoL
2 endpointsChanges of scores in 36-item Short-Form Health Survey version 2(SF-36v2) questionnaire from baseline
Time frame:at week 48
SF-36 total
change from baseline, improvement
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
IWQOL-Lite total
change from baseline, improvement
Other (unclassified)
1 endpointChanges in serum uric acid from baseline
Time frame:at week 48
change from baseline, improvement
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.