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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
140
subcutaneous injection
subcutaneous injection
Peking University People's Hospital
Beijing, Beijing Municipality, China
Change from baseline in Apnea-Hypopnea Index (AHI)
Time frame: at week 48
Percent Change From Baseline in AHI
Time frame: at week 48
Percentage of Participants With ≥50% AHI Reduction From Baseline
Time frame: at week 48
Percentage of Participants With AHI <5 or With AHI 5-14 With Epworth Sleepiness Scale (ESS) ≤10
Time frame: at week 48
Percent Change From Baseline in Body Weight
Time frame: at week 48
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