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The Objective of this trial is to evaluate the long-term safety, tolerability, weight loss efficacy and metabolic benefits of HRS-7535 tablets inobesity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Subjects will receive escalated dose of HRS-7535 or maximum tolerated dose orally |
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| Group B | Experimental | Subjects will receive escalated dose of HRS-7535 or maximum tolerated dose orally |
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| Group C | Experimental | Subjects will receive escalated dose of HRS-7535 or maximum tolerated dose orally |
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| Group D | Experimental | Subjects will receive escalated dose of HRS-7535 or maximum tolerated dose orally |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-7535 | Drug | HRS-7535 |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Treatment-emergent Adverse Event(AE) | During the 32-week open-label extension treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in body weight from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment; | from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment; | |
| Proportion of subjects with ≥5%, ≥10%, and ≥15% weight reduction from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment; |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Beijing | Beijing Municipality | 100039 | China |
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| from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment; |
| Changes in weight from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment; | from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment; |
| Changes in waist circumference from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment; | from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment; |
| Changes in body mass index (BMI) from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment; | from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment; |