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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

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

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

A Study of Eloralintide (LY3841136) in Participants With Obstructive Sleep Apnea and Obesity or Overweight (NCT07369011) is a Phase 3 interventional studying Sleep Apnea, Obstructive and Obesity, sponsored by Eli Lilly and Company. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Sleep Apnea, Obstructive, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 800 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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 heart failure * Have taken medications or alternative remedies intended for weight loss within 90 days of screening

Treatments Being Tested

DRUG

Eloralintide

Administered SC

DRUG

Placebo

Administered SC

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Cullman Clinical Trials
Cullman, Alabama, United States
Ark Clinical Research
Long Beach, California, United States
Collaborative Neuroscience Research, LLC
Los Alamitos, California, United States
Artemis Institute for Clinical Research
Riverside, California, United States
Care Access - Aurora
Aurora, Colorado, United States
Flourish Research - Miami, LLC
Miami, Florida, United States
PharmaDev Clinical Research Institute, LLC
Miami, Florida, United States
Emerald Coast Neurology - Airport Boulevard
Pensacola, Florida, United States
Teak Research Consults
Lawrenceville, Georgia, United States
EBGS Clinical Research Center
Snellville, Georgia, United States
Care Access - Shreveport 2
Shreveport, Louisiana, United States
Flourish Research - Bowie
Bowie, Maryland, United States
Revive Research Institute, Inc.
Southfield, Michigan, United States
Headlands Research-Twin Cities
Maplewood, Minnesota, United States
Clayton Sleep Institute - St. Louis - Tesson Ferry Road
St Louis, Missouri, United States
Palm Research Center Tenaya
Las Vegas, Nevada, United States
The Sleep Spot - Maimonides
Albuquerque, New Mexico, United States
Rochester Clinical Research - Buffalo
Buffalo, New York, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
Heritage Valley Multispecialty Group, Inc
Beaver, Pennsylvania, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07369011), the sponsor (Eli Lilly and Company), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07369011 clinical trial studying?

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 (IS… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07369011?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07369011?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07369011. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07369011. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.