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To assess the efficacy of HRS9531 injection compared with placebo in weight reduction in overweight or obese subjects after 36 weeks of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS9531 injection | Experimental |
| |
| HRS9531 injection Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS9531 injection | Drug | HRS9531 injection , QW,36 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in body weight | Week 0, Week 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects with weight loss of ≥5% from baseline in body weight after 36 weeks of treatment | Week 36 | |
| Proportion of Subjects with weight loss of ≥10% from baseline in body weight after 36 weeks of treatment | Week 36 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Xuzhou Medicine University | Xuzhou | Jiangsu | 221000 | China | ||
| Jinan Central Hospital |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| HRS9531 injection Placebo |
| Drug |
HRS9531 injection Placebo,QW,36 weeks |
|
| Proportion of Subjects with weight loss of ≥15% from baseline in body weight after 36 weeks of treatment | Week 36 |
| Change from baseline in body weight after 36 weeks of treatment | Week 0, Week 36 |
| Change from baseline in waist circumference after 36 weeks of treatment | Week 0, Week 36 |
| Change from baseline in BMI after 36 weeks of treatment | Week 0, Week 36 |
| Change from baseline in blood pressure after 36 weeks of treatment | Week 0, Week 36 |
| Change from baseline in total cholesterol after 36 weeks of treatment | Week 0, Week 36 |
| Change from baseline in fasting plasma glucose (FPG) after 36 weeks of treatment | Week 0, Week36 |
| Change from baseline in glycosylated haemoglobin (HbA1c) after 36 weeks of treatment | Week 0, Week 36 |
| Number of AEs During the Trial | Week 0 to Week 36 |
| Jinan |
| Shandong |
| 250013 |
| China |
| Zhejiang Hospital | Hangzhou | Zhejiang | 310007 | China |
| Sir Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310016 | China |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |