Tests XW003 injections in adults with obesity and sleep apnea
Tests XW003 injections against placebo in adults with obesity and sleep apnea.
Plain-language title generated from the registry record
Registry title: A Study of XW003 in Obese Participants With Obstructive Sleep Apnea But Not Receive Positive Airway Pressure Therapy
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07387094, who can take part
Where in China
- Peking University People's HospitalBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hangzhou Sciwind Biosciences Co., Ltd.
- Trial code
- NCT07387094
- Record updated
- 28 August 2026
- Original description
The aim of the study is to assess the efficacy and safety of XW003 injections in obese participants with OSA but not receiving PAPRead full original descriptionShow less
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
The aim of the study is to assess the efficacy and safety of XW003 injections in obese participants with OSA but not receiving PAP
Inclusion: Body mass index (BMI) ≥ 28.0 kg/m2; The results of PSG meet the diagnosis criteria of OSA and with an AHI ≥15 at screening; Participants must not have used PAP for at least 4 weeks prior to screening and not use PAP during the study; Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
Exclusion: Change of body weight >5% within 3 months prior to screening (self-reported); Have a prior or planned surgical treatment for obesity (except liposuction or abdominoplasty if performed more than 1 year prior to screening); History of endocrine disorders which have significant impact on body weight; Diagnosis of diabetes (except gestational diabetes), ketoacidosis or hypertonic state/coma; Respiratory and neuromuscular diseases that could interfere with the results of the trial; Diagnosis of Obesity Hypoventilation Syndrome or daytime hypercapnia; HbA1c ≥6.5% at screening; Fasting blood glucose ≥7.0 mmol/L or 2-hour blood glucose ≥11.1 mmol/L after oral glucose tolerance test (OGTT) at screening; participants with FBG ≥6.1 mmol/L but <7.0 mmol/L require OGTT; Have received any medication for body weight loss and blood glucose lowering or medication that could lead to significant body weight increase, within 3 months prior to screening; Have diagnosis of Cheyne Stokes Respiration, or diagnosis of Central or Mixed Sleep Apnea with % of mixed or central apneas/hypopneas ≥50%.