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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Sleep Apnea, Obstructive, Obesity, Overweight

In brief

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.

Key facts

Study ID

NCT07369011

Run by

Eli Lilly and Company

People needed

800

Starts

2026-02-10

Expected to finish

2028-04-01

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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:
• Have been on PAP therapy for at least three consecutive months prior to screening and plan to continue PAP therapy during the study

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
• 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

Where it is running

• Ark Clinical Research — Long Beach, California, United States (enrolling)
• Collaborative Neuroscience Research, LLC — Los Alamitos, California, United States (enrolling)
• Artemis Institute for Clinical Research — Riverside, California, United States (enrolling)
• Care Access - Aurora — Aurora, Colorado, United States (enrolling)
• Flourish Research - Miami, LLC — Miami, Florida, United States (enrolling)
• PharmaDev Clinical Research Institute, LLC — Miami, Florida, United States (enrolling)
• Emerald Coast Neurology - Airport Boulevard — Pensacola, Florida, United States (enrolling)
• Teak Research Consults — Lawrenceville, Georgia, United States (enrolling)
• EBGS Clinical Research Center — Snellville, Georgia, United States (enrolling)
• Care Access - Shreveport 2 — Shreveport, Louisiana, United States (enrolling)
• Flourish Research - Bowie — Bowie, Maryland, United States (enrolling)
• Revive Research Institute, Inc. — Southfield, Michigan, United States (enrolling)
• Headlands Research-Twin Cities — Maplewood, Minnesota, United States (enrolling)
• Clayton Sleep Institute - St. Louis - Tesson Ferry Road — St Louis, Missouri, United States (enrolling)
• Palm Research Center Tenaya — Las Vegas, Nevada, United States (enrolling)
• The Sleep Spot - Maimonides — Albuquerque, New Mexico, United States (enrolling)
• Rochester Clinical Research - Buffalo — Buffalo, New York, United States (enrolling)
• CTI Clinical Research Center — Cincinnati, Ohio, United States (enrolling)
• Bogan Sleep Consultants — Columbia, South Carolina, United States (enrolling)
• FutureSearch Trials of Neurology — Austin, Texas, United States (enrolling)
• Sleep Therapy Research Center — San Antonio, Texas, United States (enrolling)
• Consano Clinical Research, LLC — Shavano Park, Texas, United States (enrolling)
• Nightingale Research — Adelaide, Australia (enrolling)
• Flinders University — Bedford Park, Australia (enrolling)
• Cullman Clinical Trials — Cullman, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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