A Master Protocol for Orforglipron in Participants With Obstructive Sleep Apnea and Obesity or Overweight

Exclusion Criteria

• •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.