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This is a multicenter, randomized, open, positive parallel controlled phase III clinical trial to compare the efficacy and safety of once-weekly HD1916 and semaglutide injection and to evaluate immunogenicity in obese non-diabetic adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HD1916 | Experimental | HD1916 will be administered via subcutaneous injection once a week in subjects with obesity. |
|
| semaglutide | Active Comparator | semaglutide will be administered via subcutaneous injection once a week in subjects with obesity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HD1916 | Drug | HD1916,0.25mg/0.5mg/1.0mg/1.7mg/2.4mg,SC,once a week |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Relative percentage change in body weight from baseline at 44 weeks of treatment | Baseline through Week44 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with a weight loss of ≥5% from baseline at 44 weeks of treatment | Baseline through Week44 | |
| Proportion of subjects with a weight loss of ≥10% from baseline at 44 weeks of treatment | Baseline through Week44 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | Beijing Municipality | 100044 | China |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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This is a multicenter, randomized, open, positive parallel controlled phase III clinical trial to compare the efficacy and safety of once-weekly HD1916 and semaglutide injection and to evaluate immunogenicity in obese non-diabetic adults.
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This is a multicenter, randomized, open, positive parallel controlled phase III clinical trial to compare the efficacy and safety of once-weekly HD1916 and semaglutide injection and to evaluate immunogenicity in obese non-diabetic adults.
| semaglutide |
| Drug |
semaglutide ,0.25mg/0.5mg/1.0mg/1.7mg/2.4mg,SC,once a week |
|
| Changes in waist circumference from baseline at 44 weeks of treatment | Baseline through Week44 |
| Number of TEAE and SAE cases during the experiment | Week0 through Week44 |
| Changes in pulse from baseline at 44 weeks of treatment | Baseline through Week44 |
| Anti-drug antibodies, neutralizing antibodies (anti-drug antibody positive) | Baseline through Week44 |