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This is a multicenter, randomized, double-blind, placebo-controlled, parallel design phase II clinical trial, including a screening period of up to 2 weeks, a 36-weeks' treatment period, and a 1-week safety follow-up visit period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental |
| |
| Treatment group B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-7535 tablet | Drug | HRS-7535 tablet. |
| |
| HRS-7535 tablet placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage change from baseline in body weight. | At week 36. |
| Measure | Description | Time Frame |
|---|---|---|
| The concentration of HRS-7535 in plasma. | At week 36. | |
| The percentage change in high-sensitivity C-reactive protein (hsCRP) from baseline. | At week 36. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junmeng Shi | Contact | 17721288226 | Junmeng.shi.js12@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital, Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100032 | China |
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| Drug |
HRS-7535 tablet placebo. |
|
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| 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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