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This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical study evaluating the efficacy and safety of IBI362 9 mg in obese subjects. Subjects will be randomly assigned to IBI362 9 mg and placebo groups. All study treatment will be administered once-weekly and subcutaneously. The entire trial cycle includes a 2-week screening period, a 60-week double-blind treatment period, and a 12-week drug withdrawal follow-up period after the end of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| IBI362 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI362 | Drug | Once-weekly injections of gradually increased doses of IBI362 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change from Baseline in Body Weight | Week 60 | |
| Proportion of Participants who Achieve ≥5% Body Weight Reduction | Week 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants who Achieve ≥10% Body Weight Reduction | Week 60 | |
| Proportion of Participants who Achieve ≥15% Body Weight Reduction | Week 60 | |
| Proportion of Participants who Achieve ≥20% Body Weight Reduction |
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Inclusion Criteria:
For subjects with T2D at screening:
Exclusion Criteria:
• A self-reported change in body weight above 5% within 3 months before screening
For subjects without T2D at screening:
• HbA1c ≥6.5% as measured by local laboratory at screening
For subjects with T2D at screening:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | Beijing Municipality | 100010 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42251595 | Derived | Gao L, Jiang H, Cai H, Tian J, Shi B, Qiu W, Huang C, Han J, Zhang S, Pang S, Bi Y, Chen L, Gu X, Han J, Ma Q, Deng H, Wang Y, Li L, Han-Zhang H, Qian L, Ji L; GLORY-2 Trial Investigators. Treatment With 9-mg Mazdutide for Weight Reduction in Chinese Adults With Obesity: The GLORY-2 Randomized Clinical Trial. JAMA. 2026 Jun 7:e268142. doi: 10.1001/jama.2026.8142. Online ahead of print. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000719829 | mazdutide |
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| Placebo |
| Drug |
Once-weekly injections of volume-matched placebo |
|
| Week 60 |
| Change from Baseline in Waist Circumference | Week 60 |
| Change from Baseline in Systolic Blood Pressure | Week 60 |
| Percent Change from Baseline in Triglycerides | Week 60 |
| Percent Change from Baseline in non-high-density lipoprotein cholesteroal | Week 60 |
| Percent Change from Baseline in low-density lipoprotein cholesterol | Week 60 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |