NCT07387094

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

A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Study to Assess the Efficacy and Safety of XW003 Injections in Obese Participants With Obstructive Sleep Apnea But Not Receive Positive Airway Pressure Therapy

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Hangzhou Sciwind Biosciences Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to assess the efficacy and safety of XW003 injections in obese participants with OSA but not receiving PAP

Detailed description

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.

Conditions

• OSA - Obstructive Sleep Apnea
• Obesity

Interventions

Type	Name	Description
DRUG	XW003 injection	subcutaneous injection
DRUG	placebo with matching volume	subcutaneous injection

Timeline

• Start date: 2026-02-09
• Primary completion: 2027-12-16
• Completion: 2027-12-16
• First posted: 2026-02-04
• Last updated: 2026-04-14

Locations

1 site across 1 country: China