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The study aims to evaluate the efficacy and safety of HRS9531 in subjects with overweight or obese for 48 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A: HRS9531 injection | Experimental |
| |
| Treatment group B: HRS9531 injection | Experimental |
| |
| Treatment group C: HRS9531 injection | Experimental |
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| Placebo injection | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS9531 injection | Drug | HRS9531 injection; low dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change from baseline in weight after 48 weeks of treatment | Baseline, Week 48 | |
| Proportion of subjects with weight loss of≥5% from baseline after 48 weeks of treatment | Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with weight loss of ≥10% from baseline after 48 weeks of treatment | Week 48 | |
| Proportion of subjects with weight loss of ≥15% from baseline after 48 weeks of treatment | Week 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital Affiliated to Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
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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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Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial
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| HRS9531 injection |
| Drug |
HRS9531 injection; medium dose |
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| HRS9531 injection | Drug | HRS9531 injection, high dose |
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| Placebo | Drug | blank preparation, participants received matching placebo. |
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| Change from baseline in waist circumference after 48 weeks of treatment | Baseline, Week 48 |
| Change from baseline in weight after 48 weeks of treatment | Baseline, Week 48 |
| Change from baseline in BMI after 48 weeks of treatment | Baseline, Week 48 |
| Change from baseline in systolic blood pressure after 48 weeks of treatment | Baseline, Week 48 |
| Change from baseline in diastolic blood pressure after 48 weeks of treatment | Baseline, Week 48 |
| Change from baseline in Total Cholesterol after 48 weeks of treatment | Baseline, Week 48 |
| Change from baseline in Low Density Lipoprotein (LDL) Cholesterol after 48 weeks of treatment | Baseline, Week 48 |
| Change from baseline in Triglycerides after 48 weeks of treatment | Baseline, Week 48 |
| Change from baseline in High Density Lipoprotein (HDL) Cholesterol after 48 weeks of treatment | Baseline, Week 48 |
| Change from baseline in fasting plasma glucose (FPG) after 48 weeks of treatment | Baseline, Week 48 |
| Change from baseline in glycosylated haemoglobin (HbA1c) after 48 weeks of treatment | Baseline, Week 48 |
| Change from baseline in fasting serum insulin after 48 weeks of treatment | Baseline, Week 48 |
| Change in scores of SF-36 V2 from baseline after 48 weeks of treatment | Baseline, Week 48 |
| Number of AEs during the trial | week 0 to week 52 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |