A Study of Eloralintide (LY3841136) in Participants With Obstructive Sleep Apnea and Obesity or O… (NCT07369011) | Clinical Trial Compass
RecruitingPhase 3
A Study of Eloralintide (LY3841136) in Participants With Obstructive Sleep Apnea and Obesity or Overweight
United States, Argentina, Australia800 participantsStarted 2026-02-10
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
* unstable angina, or
* hospitalization due to congestive heart failure
* Have a history or diagnosis of New York Heart Association Functional Classification Class IV congestive…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent Change from Baseline in Body Weight
Timeframe: Baseline, Week 64
2
Change from Baseline in Apnea-Hypopnea Index (AHI)
Timeframe: Baseline, Week 64
Trial details
NCT IDNCT07369011
SponsorEli Lilly and Company
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2028-03
Contact for this trial
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or