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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Cullman Clinical Trials
  Cullman, Alabama, United States Recruiting
• Ark Clinical Research
  Long Beach, California, United States Recruiting
• Collaborative Neuroscience Research, LLC
  Los Alamitos, California, United States Recruiting
• Artemis Institute for Clinical Research
  Riverside, California, United States Recruiting
• Care Access - Aurora
  Aurora, Colorado, United States Recruiting
• Flourish Research - Miami, LLC
  Miami, Florida, United States Recruiting

+65 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.