Status:
RECRUITING
A Study of Eloralintide (LY3841136) in Participants With Obstructive Sleep Apnea and Obesity or Overweight
Lead Sponsor:
Eli Lilly and Company
Conditions:
Sleep Apnea, Obstructive
Obesity
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 d...
Eligibility Criteria
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 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 heart failure
- Have taken medications or alternative remedies intended for weight loss within 90 days of screening
Key Trial Info
Start Date :
February 10 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT07369011
Start Date
February 10 2026
End Date
April 1 2028
Last Update
March 6 2026
Active Locations (122)
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1
Cullman Clinical Trials
Cullman, Alabama, United States, 35055
2
Ark Clinical Research
Long Beach, California, United States, 90815
3
Collaborative Neuroscience Research, LLC
Los Alamitos, California, United States, 90720
4
Artemis Institute for Clinical Research
Riverside, California, United States, 92503