Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07434050
Eligibility Criteria:
Inclusion Criteria:
1. Body mass index (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:
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. HbA1c ≥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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07434050
Study Brief:
Protocol Section:
NCT07434050