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The aim of the study is to assess the efficacy and safety of XW003 injections in obese participants with OSA but not receiving PAP
In this Phase III 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 placebo, including a dose-escalation period, for up to 48 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XW003 Injection | 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 |
|---|---|---|
| Change from baseline in Apnea-Hypopnea Index (AHI) | at week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in AHI | at week 48 | |
| Percentage of Participants With ≥50% AHI Reduction From Baseline | at week 48 | |
| Percentage of Participants With AHI <5 or With AHI 5-14 With Epworth Sleepiness Scale (ESS) ≤10 |
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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 | Recruiting | Beijing | Beijing Municipality | China |
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| placebo with matching volume | Drug | subcutaneous injection |
|
| at week 48 |
| Percent Change From Baseline in Body Weight | at week 48 |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D050177 | Overweight |
| 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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