The aim of the study is to assess the efficacy and safety of XW003 injections in obese participants with OSA receiving PAP
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.
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;
Parallel
XW003 injection
Drugsubcutaneous injection
placebo with matching volume
Drugsubcutaneous injection
Change from baseline in Apnea-Hypopnea Index (AHI)
Percent Change From Baseline in AHI
Percentage of Participants With ≥50% AHI Reduction From Baseline
Percentage of Participants With AHI <5 or With AHI 5-14 With Epworth Sleepiness Scale (ESS) ≤10
Percent Change From Baseline in body weight
Click on the lead sponsor to view all of their trials.
