Phase III Study of Weekly XW003 Injections to Treat Obstructive Sleep Apnea in Obese Adults Not Using Positive Airway Pressure Therapy

What this Trial Is About

This research aims to evaluate the effectiveness and safety of XW003 injections in obese adults who have obstructive sleep apnea OSA but are not using positive airway pressure PAP therapy. The study focuses on participants with a body mass index of 28 or higher and those diagnosed with OSA based on specific sleep study criteria. It is a Phase III randomized clinical trial designed to provide detailed insights into this treatment approach. Participants will be randomly assigned to receive either a once-weekly subcutaneous injection of XW003 or a placebo for up to 48 weeks. The study includes a dose-escalation period to carefully monitor dosing effects. Both groups receive injections following the same schedule to compare the treatment and placebo outcomes effectively. During the study, participants will undergo assessments including sleep studies to measure changes in the Apnea-Hypopnea Index AHI at baseline and after 48 weeks. Additional evaluations include monitoring body weight changes and sleepiness scales. Researchers will track safety and treatment adherence throughout the study, which lasts nearly a year from start to finish.

A Study of XW003 in Obese Participants With Obstructive Sleep Apnea But Not Receive Positive Airway Pressure Therapy