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The aim of the study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of XW003 injection in Chinese adolescents with obesity
In this study, eligible participants will be randomized into one of the three cohorts in a 3:1 ratio to receive either once-weekly subcutaneous XW003 injection or placebo, for up to 20 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XW003 Dose 1 | Experimental | once weekly |
|
| XW003 Dose 2 | Experimental | once weekly |
|
| XW003 Dose 3 | Experimental | once weekly |
|
| placebo | Placebo Comparator | once weekly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XW003 injection | Drug | Subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and severity of adverse events | week 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations of XW003 | week 20 | |
| Change of body weight from baseline | week 20 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wei Zhao, Dr | Qilu Hospital of Shandong University | Principal Investigator |
| Xinguo Hou, Dr | Qilu Hospital of Shandong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Hospital of Shandong University | Jinan | Shandong | 250012 | 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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| placebo with matching volume | Drug | Subcutaneous injection |
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |