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This study is a multicenter, randomized, open-label, parallel-controlled, phase III study to compare the efficacy, safety, and tolerability of HRS9531 versus semaglutide once weekly (QW) in adult subjects with obesity
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A: HRS9531 injection | Experimental |
| |
| Treatment group B: Semaglutide Injection | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS9531 injection | Drug | HRS9531 injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change from baseline in body weight after 52 weeks of treatment | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with target reduction from baseline in body weight after 52 weeks of treatment | 52 weeks | |
| Change from baseline in waist circumference,after 52 weeks of treatment | 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chiness PLA General Hospital | Beijing | Beijing Municipality | 100853 | China | ||
| Jiangsu Province Hospital |
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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 |
|---|---|
| C000591245 | semaglutide |
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| Semaglutide Injection |
| Drug |
Semaglutide Injection |
|
| Change from baseline in body weight after 52 weeks of treatment | 52 weeks |
| Change from baseline in body mass index (BMI) after 52 weeks of treatmentChange from baseline in blood pressure,after 52 weeks of treatment | 52 weeks |
| Change from baseline in fasting plasma glucose (FPG)after 52 weeks of treatment | 52 weeks |
| Change from baseline in glycosylated haemoglobin (HbA1c) after 52 weeks of treatment | 52 weeks |
| Change from baseline in liver enzymes after 52 weeks of treatment | 52 weeks |
| Change from baseline in fasting serum insulin after 52 weeks of treatment | 52 weeks |
| Change from baseline in lipid parameters after 52 weeks of treatment | 52 weeks |
| Number of AEs during the trial. | 52 weeks |
| Nanjing |
| Jiangsu |
| 210029 |
| China |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |