NCT07434050 A Study of XW003 in Obese Participants With Obstructive Sleep Apnea Receiving Positive Airway Pressure Therapy
| NCT ID | NCT07434050 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Hangzhou Sciwind Biosciences Co., Ltd. |
| Condition | OSA - Obstructive Sleep Apnea |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2026-03-02 |
| Primary Completion | 2028-06-19 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 140 participants in total. It began in 2026-03-02 with a primary completion date of 2028-06-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of the study is to assess the efficacy and safety of XW003 injections in obese participants with OSA receiving PAP
Eligibility Criteria
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.
Contact & Investigator
Qingyun Li, Dr
PRINCIPAL INVESTIGATOR
Ruijin Hospital
Frequently Asked Questions
Who can join the NCT07434050 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying OSA - Obstructive Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07434050 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 140 participants.
Is NCT07434050 currently recruiting?
Yes, NCT07434050 is actively recruiting participants. Visit ClinicalTrials.gov or contact Hangzhou Sciwind Biosciences Co., Ltd. to inquire about joining.
Where is the NCT07434050 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07434050 clinical trial?
NCT07434050 is sponsored by Hangzhou Sciwind Biosciences Co., Ltd.. The principal investigator is Qingyun Li, Dr at Ruijin Hospital. The trial plans to enroll 140 participants.