OSA - Obstructive Sleep ApneaPhase 3NCT07387094
A Study of XW003 in Obese Participants With Obstructive Sleep Apnea But Not Receive 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 but not 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
- 9 Feb 2026to 16 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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;
- 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.
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;
Show all 10Show fewer
- Diagnosis of Obesity Hypoventilation Syndrome or daytime hypercapnia;
- Change of body weight >5% within 3 months prior to screening (self-reported);
- 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
Peking University People's Hospital
Beijing, Beijing Municipality
Linong Ji, Dr, (86)010-88324516, 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 But Not Receive Positive Airway Pressure Therapy
The aim of the study is to assess the efficacy and safety of XW003 injections in obese participants with OSA but not 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, Obesity, OSA, 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
Also called Ecnoglutide injection
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 posted4 Feb 2026
- Study start9 Feb 2026
- Primary completion16 Dec 2027 (estimated)
- Study completion16 Dec 2027 (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
- Linong Ji, Dr, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07387094
- Sponsor's protocol ID
- SCW0502-5031
- 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
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 But Not Receive Positive Airway Pressure Therapy
- ClinicalTrials.gov ID
- NCT07387094
- Acronym / sponsor ID
- SCW0502-5031
- Conditions
- OSA - Obstructive Sleep Apnea, Obesity
- Keywords
- XW003, Ecnoglutide, Obesity, OSA, GLP-1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Hangzhou Sciwind Biosciences Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Feb 2026 (actual)
- Primary completion
- 16 Dec 2027 (estimated)
- Study completion
- 16 Dec 2027 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to assess the efficacy and safety of XW003 injections in obese participants with OSA but not receiving PAP
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XW003 Injection | Experimental | Drug: XW003 injectiononce weekly |
| Placebo | Placebo comparator | Drug: placebo with matching volumeonce weekly |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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%;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XW003 injectionAlso: Ecnoglutide injectionsubcutaneous injection | Drug | XW003 Injection |
| placebo with matching volumesubcutaneous injection | Drug | Placebo |
Primary outcome
Change from baseline in Apnea-Hypopnea Index (AHI)
Time frame: at week 48
4 secondary outcomes
Percent Change From Baseline in AHI
Time frame: at week 48
Percentage of Participants With ≥50% AHI Reduction From Baseline
Time frame: at week 48
Percentage of Participants With AHI <5 or With AHI 5-14 With Epworth Sleepiness Scale (ESS) ≤10
Time frame: at week 48
Percent Change From Baseline in Body Weight
Time frame: at week 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for OSA - Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Linong Ji, Dr principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Apnea-Hypopnea Index (AHI) (time frame: at week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.