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The aim of the study is to compare the efficacy and safety of XW003 injection versus semaglutide injection in Chinese adults with obesity
In this Phase II study, eligible participants will be randomized into one of the two cohorts in a 1:1 ratio to receive once-weekly subcutaneous XW003 injection or semaglutide injection, including a dose-escalation period, a core treatment period and a treatment extension period, for up to 60 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XW003 | Experimental | once weekly |
|
| semaglutide | Active Comparator | once weekly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XW003 injection | Drug | Subcutaneous injection |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in body weight relative to baseline | week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportions of participants with weight loss ≥5% from baseline | week 48 | |
| Proportions of participants with weight loss ≥10% from baseline | week 48 | |
| Proportions of participants with weight loss ≥15% from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linong Ji, Dr | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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| semaglutide injection | Drug | Subcutaneous injection |
|
| week 48 |
| The change in waist circumference relative to the baseline | week 48 |
| Changes in body mass index (BMI) relative to baseline | week 48 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |