Phase III Study of Weekly XW003 Injections for Obese Adults With Obstructive Sleep Apnea Using Positive Airway Pressure Therapy

What this Trial Is About

Researchers are evaluating the safety and effectiveness of XW003 injections in adults who are obese and have obstructive sleep apnea OSA while receiving positive airway pressure PAP therapy. This Phase III study aims to understand how XW003 injections impact breathing events during sleep and body weight in this population. Participants must be adults with a diagnosis of OSA confirmed by sleep study results and a history of unsuccessful weight loss attempts. Eligible participants will be randomly assigned to receive either a once-weekly subcutaneous injection of XW003 or a matching placebo for up to 48 weeks. The study includes a dose-escalation period and is conducted under a double-blind design to compare the effects of the study drug versus placebo. Participants will continue their PAP therapy throughout the study. During the trial, participants will undergo assessments including sleep studies to measure changes in the Apnea-Hypopnea Index AHI, body weight measurements, and evaluations of daytime sleepiness using the Epworth Sleepiness Scale. These assessments will be conducted at baseline and at week 48. Researchers will monitor safety and treatment adherence over the study period, which lasts approximately 48 weeks.

A Study of XW003 in Obese Participants With Obstructive Sleep Apnea Receiving Positive Airway Pressure Therapy