RecruitingSleep Apnea, ObstructiveObesityOverweight

A Study of Eloralintide (LY3841136) in Participants With Obstructive Sleep Apnea and Obesity or Overweight

Eligible age

18+ yrs

Accepts

All genders

Locations

16 states

Healthy volunteers

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About this study

The purpose of the studies is to evaluate the efficacy and safety of eloralintide in participants with moderate-to-severe obstructive sleep apnea and obesity or overweight. YDAO is a master protocol designed to support two independent studies: YSA1 and YSA2. Study YSA1 will include participants who are unable or unwilling to use Positive Airway Pressure (PAP) therapy and study YSA2 will include participants who are on PAP therapy for at least 3 months at time of screening and plan to continue PAP therapy during the study. Participants will be assigned to the Intervention-Specific Appendix (ISA) that reflects their current PAP usage. Participation in the study will last about 76 weeks.

Sponsor: Eli Lilly and Company

You may qualify if…

✓ Confirmed history of moderate-to-severe OSA
✓ Have an AHI ≥ 15 on polysomnography (PSG) as part of the study at screening
✓ Have a BMI ≥27 kg/m2 at screening
✓ Have a stable body weight (\<5% body weight change) for 90 days prior to screening
✓ Have a history of at least one self-reported unsuccessful dietary effort to reduce body weight
✓ For YSA1 Participants:
✓ Are unable or unwilling to use PAP therapy
✓ For YSA2 Participants:

You may not qualify if…

✕ Have a prior or planned surgical treatment for obesity (liposuction, cryolipolysis, or abdominoplasty allowed if performed \>1 year before screening)
✕ Have a prior or planned endoscopic procedure and/or device-based therapy for obesity (prior device-based therapy acceptable if device removal was more than 6 months prior to screening)
✕ Any previous or planned surgery for sleep apnea or major ear, nose or throat surgery that still may affect breathing at time of screening
✕ Have type 1 diabetes, type 2 diabetes, or any other type of diabetes
✕ Have had within 90 days prior to screening:
✕ acute myocardial infarction
✕ cerebrovascular accident (stroke)
✕ coronary artery revascularization