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The aim of this trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS9531 injection compared with placebo in adolescents with obesity
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A: HRS9531 injection or Placebo | Experimental |
| |
| Treatment group B: HRS9531 injection or Placebo | Experimental |
| |
| Treatment group C: HRS9531 injection or Placebo | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS9531 injection;Placebo | Drug | Drug: HRS9531 injection; low dose Drug: Placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AEs) | up to Week 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration (Cmax) of HRS9531 | up to Week 28 | |
| Trough concentration (Ctrough) of HRS9531 | up to Week 28 | |
| Area under the curve from time zero to end of dosing interval (AUC0-tau) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shujin Cheng | Contact | +86-0518-82342973 | shujin.cheng@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430030 | China |
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| HRS9531 injection;Placebo | Drug | Drug: HRS9531 injection; medium dose Drug: Placebo |
|
| HRS9531 injection;Placebo | Drug | Drug: HRS9531 injection; high dose Drug: Placebo |
|
| up to Week 28 |
| Changes from baseline in BMI | up to Week 24 |
| Change from baseline in body weight | up to Week 24 |
| Change from baseline in waist circumference | up to Week 24 |
| Anti-HRS9531 antibodies (ADA) | up to Week 28 |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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