Once-weekly XW003 injections for people with obesity and obstructive sleep apnea on PAP therapy

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

This Phase III, randomized, placebo-controlled study will assign eligible participants 1:1 to receive once-weekly subcutaneous XW003 or matching placebo, including a dose-escalation period, for up to 48 weeks. Participants must have BMI ≥28 kg/m2, an AHI ≥15 on diagnostic PSG, and have used PAP therapy for at least three consecutive months prior to screening while planning to continue PAP during the study. The trial will monitor efficacy outcomes related to OSA severity and weight, along with safety and tolerability measures. Study visits and assessments will be conducted at the single investigational site in Shanghai.

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. Have been on PAP therapy for at least 3 consecutive months prior to screening and plan to continue PAP therapy 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 (selfreported);
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

• Rui Jin Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Qingyun Li, Dr — Ruijin 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.