RecruitingPhase 3

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

China140 participantsStarted 2026-02-09

Plain-language 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

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. History of endocrine disorders which have significant impact on body weight;
✕. Diagnosis of diabetes (except gestational diabetes), ketoacidosis or hypertonic state/coma;
✕. 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 diagnosis of Cheyne Stokes Respiration, or diagnosis of Central or Mixed Sleep Apnea with % of mixed or central apneas/hypopneas ≥50%;
✕. Respiratory and neuromuscular diseases that could interfere with the results of the trial;
✕. Diagnosis of Obesity Hypoventilation Syndrome or daytime hypercapnia;
✕. Change of body weight \>5% within 3 months prior to screening (self-reported);

Change from baseline in Apnea-Hypopnea Index (AHI)

Timeframe: at week 48

NCT IDNCT07387094

SponsorHangzhou Sciwind Biosciences Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12-16

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. History of endocrine disorders which have significant impact on body weight;
✕. Diagnosis of diabetes (except gestational diabetes), ketoacidosis or hypertonic state/coma;
✕. 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 diagnosis of Cheyne Stokes Respiration, or diagnosis of Central or Mixed Sleep Apnea with % of mixed or central apneas/hypopneas ≥50%;
✕. Respiratory and neuromuscular diseases that could interfere with the results of the trial;
✕. Diagnosis of Obesity Hypoventilation Syndrome or daytime hypercapnia;
✕. Change of body weight \>5% within 3 months prior to screening (self-reported);