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This is a multicenter, randomized, double-blind, placebo-controlled Phase II study to evaluate the efficacy and safety of once-weekly HRS-4729 injection in adults with obesity without diabetes. Approximately 252 participants will be enrolled. The primary endpoint is percent change in body weight from baseline at Week 32 versus placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose 1 | Experimental | Drug: HRS-4729 Injection |
|
| Dose 2 | Experimental | Drug: HRS-4729 Injection |
|
| Dose 3 | Experimental | Drug: HRS-4729 Injection |
|
| Dose 4 | Experimental | Drug: HRS-4729 Injection |
|
| Dose 5 | Experimental | Drug: HRS-4729 Injection |
|
| Dose 6 | Experimental | Drug: HRS-4729 Injection |
|
| Placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-4729 Injection | Drug | HRS-4729 Injection; Dose 1 |
| |
| HRS-4729 Injection |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Body Weight | Baseline, Week 32 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Body Weight | Baseline, Week 40 | |
| Change From Baseline in Body Weight | Baseline, Week 32 and 40 | |
| Change from Baseline in Body Mass Index (BMI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ziwei Du | Contact | +86 0518-81220121 | ziwei.du.zd9@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200025 | China |
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| Placebo Comparator |
Drug: HRS-4729 Injection Placebo |
|
| Drug |
HRS-4729 Injection; Dose 2 |
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| HRS-4729 Injection | Drug | HRS-4729 Injection; Dose 3 |
|
| HRS-4729 Injection; | Drug | HRS-4729 Injection; Dose 4 |
|
| HRS-4729 Injection; | Drug | HRS-4729 Injection; Dose 5 |
|
| HRS-4729 Injection; | Drug | HRS-4729 Injection; Dose 6 |
|
| HRS-4729 Injection Placebo | Drug | HRS-4729 Injection Placebo |
|
| Baseline, Week 32 and 40 |
| Change from Baseline in Waist Circumference | Baseline, Week 32 and 40 |
| Change from Baseline in Blood Pressure | Baseline, Week 32 and 40 |
| Change from Baseline in Glucose Level | Baseline, Week 32 and 40 |
| TEAEs | Baseline, Week 44 |
| 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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