Eloralintide for Obstructive Sleep Apnea in Adults With Obesity or Overweight
Tests eloralintide in adults with obstructive sleep apnea and excess weight.
Plain-language title generated from the registry record
Registry title: A Study of Eloralintide (LY3841136) in Participants With Obstructive Sleep Apnea and Obesity or Overweight
Key facts
- Where
- Calgary, Lévis, Québec, Saint-Laurent, Toronto, and Trois-Rivières, CanadaSee the 6 sites
- Phase
- Phase 3
Where in Canada
- MyCliniResearch, Inc.Calgary, CanadaTaking people
- Alpha Recherche Clinique - LévisLévis, CanadaTaking people
- Alpha Recherche CliniqueQuébec, CanadaTaking people
- C.I.C. Saint-LaurentSaint-Laurent, CanadaTaking people
- Maple Leaf ResearchToronto, CanadaTaking people
- C.I.C. Mauricie inc.Trois-Rivières, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT07369011EU 2025-523769-11-00
- Record updated
- 4 November 2026
- Original description
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.Read full original descriptionShow less
A Master Protocol for Phase 3 Randomized, Double-Blind, Placebo-Controlled Studies to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Moderate to Severe Obstructive Sleep Apnea, and Obesity or Overweight
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.
Inclusion: 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:; Have been on PAP therapy for at least three consecutive months prior to screening and plan to continue PAP therapy during the study.
Exclusion: 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 had within 90 days prior to screening:; acute myocardial infarction; cerebrovascular accident (stroke); coronary artery revascularization; unstable angina, or; hospitalization due to congestive heart failure; Have taken medications or alternative remedies intended for weight loss within 90 days of screening; Have type 1 diabetes, type 2 diabetes, or any other type of diabetes; Have a history or diagnosis of New York Heart Association Functional Classification Class IV congestive heart failure.