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

Korábbi kezelés

• Had any previous or planned upper airway surgery for sleep apnea or major ear, nose or throat surgery
• Active device treatment of OSA other than PAP therapy
• 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 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.

Más betegség

• Have Type 1 diabetes (T1D) or Type 2 diabetes (T2D), history of ketoacidosis, or hyperosmolar state/coma
• Diagnosis of Obesity Hypoventilation Syndrome or daytime hypercapnia.
• Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator.
• Have obesity induced by other endocrinologic disorders or diagnosed monogenetic or syndromic forms of obesity.
  • Study 2 GZ02 exclusion criteria

Laborértékek

• Have HbA1c ≥6.5% (≥ 48 mmol/mol), as determined by the central laboratory at Visit 1.

Egyéb

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

• Master GZRA inclusion criteria
• have AHI ≥15 on PSG as part of the trial at screening (V1).
• have body mass index (BMI) ≥27 kg/m²
  • Study 1 GZ01 inclusion criteria
• Participants who are unable or unwilling to use PAP therapy.
• Participants must not have used PAP for at least 4 weeks prior to screening.
  • Study 2 GZ02 inclusion criteria
• 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.