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Eloralintide for people with obstructive sleep apnea who are overweight or obese

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

PHASE3 · Eli Lilly and Company · NCT07369011

This study will test whether the drug eloralintide helps adults with moderate-to-severe obstructive sleep apnea who are overweight or obese, whether they use PAP therapy or not.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment800 (estimated)
Ages18 Years and up
SexAll
SponsorEli Lilly and Company (industry)
Locations123 sites (Cullman, Alabama and 122 other locations)
Trial IDNCT07369011 on ClinicalTrials.gov

What this trial studies

This phase 3 master protocol (YDAO) enrolls adults with moderate-to-severe obstructive sleep apnea and a BMI of at least 27 kg/m2 and assigns them to an intervention-specific appendix based on their current PAP use (YSA1 for those not using PAP and YSA2 for those on PAP). Participants are randomized to receive eloralintide or placebo and are followed with regular visits and monitoring over about 76 weeks. Key entry requirements include an AHI ≥15 on study polysomnography and stable weight for the prior 90 days. Safety and treatment effects on sleep apnea and related outcomes are monitored throughout the treatment period.

Who should consider this trial

Good fit: Adults with confirmed moderate-to-severe OSA (AHI ≥15), a BMI ≥27 kg/m2, stable recent weight, and either unable or unwilling to use PAP or currently using PAP for at least three months are the intended participants.

Not a fit: People with mild OSA (AHI <15), recent major weight change, prior or planned bariatric or certain device-based obesity procedures, or prior/planned surgery for sleep apnea are unlikely to qualify or benefit.

Why it matters

Potential benefit: If successful, eloralintide could reduce sleep apnea severity and support weight loss in adults with moderate-to-severe OSA who are overweight or obese.

How similar studies have performed: Prior studies of weight-loss medications have shown improvements in OSA, but eloralintide as a specific agent is newer and large phase 3 evidence for this drug is limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Cullman, Alabama and 122 other locations

+73 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Sleep Apnea, Obstructive, Obesity, Overweight

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.