Weekly XW003 injections for people with obesity and obstructive sleep apnea not using PAP

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this Phase 3 randomized, placebo-controlled trial, adults with obesity and polysomnography-confirmed obstructive sleep apnea who are not using PAP will be assigned 1:1 to once-weekly subcutaneous XW003 or matching placebo. The dosing includes a planned dose-escalation period followed by maintenance dosing for up to 48 weeks. Key eligibility requires BMI ≥28 kg/m2, AHI ≥15, no PAP use for at least four weeks prior to screening, and exclusion of diabetes or certain endocrine, respiratory, or neuromuscular disorders. The study collects safety data and measures efficacy outcomes such as changes in apnea-hypopnea index and body weight.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Body mass index (BMI) ≥ 28.0 kg/m2;
2. The results of PSG meet the diagnosis criteria of OSA and with an AHI ≥15 at screening;
3. Participants must not have used PAP for at least 4 weeks prior to screening and not use PAP during the study;
4. Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.

Exclusion Criteria:

1. History of endocrine disorders which have significant impact on body weight;
2. Diagnosis of diabetes (except gestational diabetes), ketoacidosis or hypertonic state/coma;
3. HbA1c ≥6.5% at screening;
4. 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;
5. Have diagnosis of Cheyne Stokes Respiration, or diagnosis of Central or Mixed Sleep Apnea with % of mixed or central apneas/hypopneas ≥50%;
6. Respiratory and neuromuscular diseases that could interfere with the results of the trial;
7. Diagnosis of Obesity Hypoventilation Syndrome or daytime hypercapnia;
8. Change of body weight \>5% within 3 months prior to screening (self-reported);
9. Have a prior or planned surgical treatment for obesity (except liposuction or abdominoplasty if performed more than 1 year prior to screening);
10. 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.

Where it's running

• Peking University People's Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Linong Ji, Dr — Peking University People's Hospital

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.