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New treatment option for OSA - Obstructive Sleep Apnea
Official title A Study of XW003 in Obese Participants With Obstructive Sleep Apnea But Not Receive Positive Airway Pressure Therapy
ClinicalTrials.gov ID: NCT07387094
What this study is testing
What is XW003 injection?
XW003 injection is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for osa - obstructive sleep apnea.
Also referred to as Ecnoglutide injection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The aim of the study is to assess the efficacy and safety of XW003 injections in obese participants with OSA but not receiving PAP
- Phase 3: a large, late-stage study
- Time commitment: about 48 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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;
See the full eligibility criteria
- 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.
- 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;
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 48 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.