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The study is designed to assess the efficacy and safety of multiple doses of IBI362 in Chinese adolescent subjects with obesity or overweight. It plans to enroll 180 adolescents (aged ≥12 and <18 years) who have failed to achieve a 5 kg weight reduction after at least 12 weeks of dietary and exercise intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| IBI362-dose2 | Experimental |
| |
| IBI362-dose1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo SA.QW |
| |
| IBI362 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change from Baseline in BMI | Week 32 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with ≥5% BMI Reduction | Week 32 | |
| Percent Change from Baseline in BMI | Week 52 | |
| Percentage of Participants with ≥5% BMI Reduction |
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Inclusion Criteria:
Participants must meet all of the following inclusion criteria to be enrolled:
Key Inclusion Criteria:
Exclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoyan li | Contact | 18756032014 | xiaoyan.li@innoventbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital, Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310052 | China |
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| ID | Term |
|---|---|
| C000719829 | mazdutide |
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| Drug |
IBI362 SA.QW |
|
| Week 52 |