Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Eli Lilly and Company
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
have AHI ≥15 on PSG as part of the trial at screening (V1).
have body mass index (BMI) ≥27 kg/m²
Participants who are unable or unwilling to use PAP therapy.
Participants must not have used PAP for at least 4 weeks prior to screening.
Participants who have been on PAP therapy for at least 3 consecutive months prior to study start and plan to continue PAP therapy during the study.
You may not be if
Have Type 1 diabetes (T1D) or Type 2 diabetes (T2D), history of ketoacidosis, or hyperosmolar state/coma
Have HbA1c ≥6.5% (≥ 48 mmol/mol), as determined by the central laboratory at Visit 1.
Had any previous or planned upper airway surgery for sleep apnea or major ear, nose or throat surgery
Have diagnosis of Central or Mixed Sleep Apnea with % of mixed or central apneas/hypopneas ≥50%, or diagnosis of Cheyne Stokes Respiration
Diagnosis of Obesity Hypoventilation Syndrome or daytime hypercapnia.
Active device treatment of OSA other than PAP therapy
Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator.
Have a self-reported change in body weight \>5 kg within 3 months prior to screening
Have a prior or planned surgical treatment for obesity (excluding liposuction, abdominoplasty or cryolipolysis if performed more than 1 year prior to screening)
Have a prior or planned endoscopic and/or present device-based therapy for obesity.
Have obesity induced by other endocrinologic disorders or diagnosed monogenetic or syndromic forms of obesity.
Have personal or job-related responsibilities, or in the opinion of the investigator have any situation that would make it unsafe to stop PAP therapy for 7 days prior to PSG testing during the study.
Are unwilling to temporary discontinue PAP therapy for 7 days prior to PSG testing during the study.
Clareo Health | A Master Protocol for Orforglipron in Participants With Obstructive Sleep Apnea and Obesity or Overweight
