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RecruitingNCT07387094Updated Aug 28, 2026

A Study of XW003 in Obese Participants With Obstructive Sleep Apnea But Not Receive 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 Feb 2026; still recruiting 9 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 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.

02

Conditions studied

  • OSA - Obstructive Sleep Apnea
  • Obesity

Keywords

  • XW003
  • Ecnoglutide
  • Obesity
  • OSA
  • 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. Participants must not have used PAP for at least 4 weeks prior to screening and not use PAP 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 (self-reported);
  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

    Also known as: Ecnoglutide 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

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2026 (actual). Primary completion is estimated for Dec 2027, 22 months after the start.

Of 25 phase 3 interventional studies under Sleep Apnea, Obstructive, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 32. This study's planned 22 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 28, 2026
First posted
Feb 4, 2026
StartActual
Feb 9, 2026
Primary completionEst.
Dec 16, 2027
CompletionEst.
Dec 16, 2027
Last update
Aug 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
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 ↗
10

Registry details

Key details

Study ID
NCT07387094
Lead sponsor
Hangzhou Sciwind Biosciences Co., Ltd.
Responsible party
Sponsor
First posted
Feb 4, 2026
Start date
Feb 9, 2026
Primary completion
Dec 16, 2027 (estimated)
Completion
Dec 16, 2027 (estimated)
Last update
Aug 28, 2026

Study contacts

Linong Ji, Dr
principal investigator · Peking University People's 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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