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

Prior treatment

• Change of body weight \>5% within 3 months prior to screening (selfreported);
• Have a prior or planned surgical treatment for obesity (except liposuction or abdominoplasty if performed more than 1 year prior to screening);

Other illness

• History of endocrine disorders which have significant impact on body weight;
• Diagnosis of diabetes (except gestational diabetes), ketoacidosis or hypertonic state/coma;
• Respiratory and neuromuscular diseases that could interfere with the results of the trial;
• Diagnosis of Obesity Hypoventilation Syndrome or daytime hypercapnia;

Lab values

• 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 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.

Other

• Have diagnosis of Cheyne Stokes Respiration, or diagnosis of Central or Mixed Sleep Apnea with % of mixed or central apneas/hypopneas ≥50%;

• 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.