Recruiting

Phase 3

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

Sponsor:

Eli Lilly and Company

Code:

NCT07369011

Conditions

Sleep Apnea, Obstructive

Obesity

Overweight

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Eloralintide

Placebo

Study Details

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 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.

Conditions

Sleep Apnea, Obstructive

Obesity

Overweight

Study ID

NCT07369011

Start date

Feb 10, 2026

Status verified date

Aug, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

800 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Eloralintide (YSA1)

Participants will receive eloralintide subcutaneously (SC)

placebo comparator: Placebo (YSA1)

Participants will receive placebo SC

experimental: Eloralintide (YSA2)

Participants will receive eloralintide SC

placebo comparator: Placebo (YSA2)

Participants will receive placebo SC

Interventions

Eloralintide

Administered SC

Placebo

Administered SC

Primary outcome measure

Percent Change from Baseline in Body Weight [ Time Frame: Baseline, Week 64 ]
Change from Baseline in Apnea-Hypopnea Index (AHI) [ Time Frame: Baseline, Week 64 ]

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559 LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Cullman Clinical Trials

Recruiting

Cullman, Alabama, United States, 35055

Contacts

256-708-2826

Principal Investigator:

Randall Quinn

Ark Clinical Research

Recruiting

Long Beach, California, United States, 90815

Contacts

562-997-1000

Principal Investigator:

Apinya Vutikullird

Collaborative Neuroscience Research, LLC

Recruiting

Los Alamitos, California, United States, 90720

Contacts

714-799-7799

Principal Investigator:

Steven Reynolds

Artemis Institute for Clinical Research

Recruiting

Riverside, California, United States, 92503

Contacts

951-374-1190

Principal Investigator:

Jack Vu

Care Access - Aurora

Recruiting

Aurora, Colorado, United States, 80012

Contacts

720-368-4865

Principal Investigator:

Mauricio Waintrub

Flourish Research - Miami, LLC

Recruiting

Miami, Florida, United States, 33135

Contacts

305-631-6704

Principal Investigator:

Mark Rosenthal

PharmaDev Clinical Research Institute, LLC

Recruiting

Miami, Florida, United States, 33176

Contacts

305-420-5636

Principal Investigator:

Edward Mezerhane

Emerald Coast Neurology - Airport Boulevard

Recruiting

Pensacola, Florida, United States, 32504

Contacts

850-438-1136

Principal Investigator:

David Bear

Teak Research Consults

Recruiting

Lawrenceville, Georgia, United States, 30043

Principal Investigator:

Kamar Alabi

EBGS Clinical Research Center

Recruiting

Snellville, Georgia, United States, 30078

Contacts

770-729-4517

Principal Investigator:

Aliu Sanni

Care Access - Shreveport 2

Recruiting

Shreveport, Louisiana, United States, 71105

Contacts

318-209-3290

Principal Investigator:

David Green

Flourish Research - Bowie

Recruiting

Bowie, Maryland, United States, 20715

Contacts

410-824-1342

Principal Investigator:

BARBARA HUTCHINSON

Revive Research Institute, Inc.

Recruiting

Southfield, Michigan, United States, 48075

Contacts

248-829-3103

Principal Investigator:

Syed Raza

Headlands Research-Twin Cities

Recruiting

Maplewood, Minnesota, United States, 55109

Principal Investigator:

Charlene McEvoy

Clayton Sleep Institute - St. Louis - Tesson Ferry Road

Recruiting

St Louis, Missouri, United States, 63123

Contacts

314-645-6005

Principal Investigator:

Joseph Ojile

Palm Research Center Tenaya

Recruiting

Las Vegas, Nevada, United States, 89128

Contacts

702-736-5161

Principal Investigator:

Samer Nakhle

The Sleep Spot - Maimonides

Recruiting

Albuquerque, New Mexico, United States, 87107

Contacts

505-998-7200

Principal Investigator:

Kisria Rechul

Rochester Clinical Research - Buffalo

Recruiting

Buffalo, New York, United States, 14127

Principal Investigator:

Rajiv Jain

CTI Clinical Research Center

Recruiting

Cincinnati, Ohio, United States, 45212

Contacts

513-721-3868

Principal Investigator:

James Maynard

Bogan Sleep Consultants

Recruiting

Columbia, South Carolina, United States, 29201

Contacts

803-251-3093

Principal Investigator:

Laura Herpel

FutureSearch Trials of Neurology

Recruiting

Austin, Texas, United States, 78731

Contacts

512-380-9925

Principal Investigator:

Gregory Tempest

Sleep Therapy Research Center

Recruiting

San Antonio, Texas, United States, 78229

Principal Investigator:

Nagwa Lamaie

Consano Clinical Research, LLC

Recruiting

Shavano Park, Texas, United States, 78231

Contacts

210-545-4900

Principal Investigator:

Michelle Welch

MyCliniResearch, Inc.

Recruiting

Calgary, Canada, T2Z 3R6

Contacts

5873320600

Principal Investigator:

Wilfred Alonso

Alpha Recherche Clinique - Lévis

Recruiting

Lévis, Canada, G6V 0C9

Contacts

418-380-1112

Principal Investigator:

Dominique Deschênes

Alpha Recherche Clinique

Recruiting

Québec, Canada, G2J 0C4

Principal Investigator:

Nancy Labrecque

C.I.C. Saint-Laurent

Recruiting

Saint-Laurent, Canada, H4R 3C8

Contacts

8193731128

Principal Investigator:

Emilie Millaire

Maple Leaf Research

Recruiting

Toronto, Canada, M5G 1K2

Contacts

4164657936

Principal Investigator:

Graham Smith

C.I.C. Mauricie inc.

Recruiting

Trois-Rivières, Canada, G8T 7A1

Principal Investigator:

Pierre-Alexandre Menard

More Information

Sponsor

Eli Lilly and Company

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-08-24.