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RecruitingNCT07434050Updated Aug 28, 2026

A Study of XW003 in Obese Participants With Obstructive Sleep Apnea Receiving Positive Airway Pressure Therapy

A Phase 3 interventional study of XW003 injection and placebo with matching volume in OSA - Obstructive Sleep Apnea and Obesity, sponsored by Hangzhou Sciwind Biosciences Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-28.

Sponsored by Hangzhou Sciwind Biosciences Co., Ltd. · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2026; still recruiting 8 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • OSA - Obstructive Sleep Apnea
  • Obesity

Keywords

  • XW003
  • Ecnoglutide
  • OSA
  • Obesity
  • GLP-1
03

In context

Sleep Apnea, Obstructive

2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.

This study's planned enrollment of 140 is above the median of 52 across 1,472 interventional studies indexed under Sleep Apnea, Obstructive.

Browse Sleep Apnea, Obstructive studies →

Lead sponsor

Hangzhou Sciwind Biosciences Co., Ltd. is the lead sponsor of 14 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. (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

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. ≥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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
140 participants (estimated)

Study arms

  • Experimental
    XW003 Injection

    once weekly

    Drug: XW003 injection

  • Placebo comparator
    Placebo

    once weekly

    Drug: placebo with matching volume

Interventions

  • subcutaneous injection

  • Drugplacebo with matching volume

    subcutaneous injection

06

What researchers measure

Primary outcomes

  1. Change from baseline in Apnea-Hypopnea Index (AHI)

    Time frame: at week 48

Secondary outcomes

  1. Percent Change From Baseline in AHI

    Time frame: at week 48

  2. Percentage of Participants With ≥50% AHI Reduction From Baseline

    Time frame: at week 48

  3. Percentage of Participants With AHI <5 or With AHI 5-14 With Epworth Sleepiness Scale (ESS) ≤10

    Time frame: at week 48

  4. Percent Change From Baseline in body weight

    Time frame: at week 48

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07434050
Lead sponsor
Hangzhou Sciwind Biosciences Co., Ltd.
Responsible party
Sponsor
First posted
Feb 25, 2026
Start date
Mar 2, 2026
Primary completion
Jun 19, 2028 (estimated)
Completion
Jun 19, 2028 (estimated)
Last update
Aug 28, 2026

Study contacts

Qingyun Li, Dr
principal investigator · Ruijin Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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Studies of the drug tested here: Ecnoglutide

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