OSA - Obstructive Sleep ApneaPhase 3NCT07434050
A Study of XW003 in Obese Participants With Obstructive Sleep Apnea Receiving Positive Airway Pressure Therapy
A Phase 3 study testing XW003 injection in people with OSA - Obstructive Sleep Apnea and Obesity, run by Hangzhou Sciwind Biosciences Co., Ltd. at 1 site in China.
Trial summary
The aim of the study is to assess the efficacy and safety of XW003 injections in obese participants with OSA receiving PAP Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- OSA - Obstructive Sleep Apnea, Obesity
- What is being tested?
- XW003 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 2 Mar 2026to 19 Jun 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- Have been on PAP therapy for at least 3 consecutive months prior to screening and plan to continue PAP therapy during the study;
- Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
Who cannot join
- 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;
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- Diagnosis of Obesity Hypoventilation Syndrome or daytime hypercapnia;
- Change of body weight >5% within 3 months prior to screening (selfreported);
- Have a prior or planned surgical treatment for obesity (except liposuction or abdominoplasty if performed more than 1 year prior to screening);
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Rui Jin Hospital
Shanghai, Shanghai Municipality, 200025
Qingyun Li, Dr, (86)021-34186000, ra@sciwindbio.com
About this study
Official title: 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 Receiving Positive Airway Pressure Therapy
The aim of the study is to assess the efficacy and safety of XW003 injections in obese participants with OSA receiving PAP
Read the detailed description
In this Phase III study, eligible participants will be randomized into one of the two cohorts in a 1:1 ratio to receive once-weekly subcutaneous XW003 injection or placebo, including a dose-escalation period, for up to 48 weeks
- Conditions
- OSA - Obstructive Sleep Apnea, Obesity
- Being tested
- XW003 injection, placebo with matching volume
- Keywords
- XW003, Ecnoglutide, OSA, Obesity, GLP-1
- Medical subject headings
- Sleep Apnea, Obstructive, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XW003 injectionDrug
subcutaneous injection
placebo with matching volumeDrug
subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| XW003 Injection | Experimental | once weekly Receives: Drug: XW003 injection |
| Placebo | Placebo comparator | once weekly Receives: Drug: placebo with matching volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Apnea-Hypopnea Index (AHI)
Measured: at week 48
Secondary outcomes (4)
Percent Change From Baseline in AHI
Measured: at week 48
Percentage of Participants With ≥50% AHI Reduction From Baseline
Measured: at week 48
Percentage of Participants With AHI <5 or With AHI 5-14 With Epworth Sleepiness Scale (ESS) ≤10
Measured: at week 48
Percent Change From Baseline in body weight
Measured: at week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start2 Mar 2026
- Primary completion19 Jun 2028 (estimated)
- Study completion19 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OSA - Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Sciwind Biosciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qingyun Li, Dr, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07434050
- Sponsor's protocol ID
- SCW0502-5032
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No