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

Launched by ELI LILLY AND COMPANY · Oct 17, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called orforglipron for people who have obstructive sleep apnea (OSA) and are overweight or obese. The trial includes two separate studies: one for participants who cannot or do not want to use a common treatment called PAP therapy, and another for those who have been using PAP therapy for at least three months and plan to continue using it during the study. The goal is to see how effective and safe orforglipron is for these individuals.

To participate, you need to be between 65-74 years old, have moderate to severe sleep apnea (as shown by a specific test), and have a body mass index (BMI) of 27 or higher. However, certain health conditions, such as diabetes or recent major surgeries, may prevent you from joining. If you are eligible, you can expect to be assigned to one of the two studies based on your current treatment for sleep apnea, and you’ll be monitored closely throughout the trial. This study is currently recruiting participants, and it's a great opportunity to contribute to research that could help improve treatments for OSA.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • Master GZRA 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.
• • Study 2 GZ02 exclusion criteria
• • 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.