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NCT07369011PHASE3Recruiting

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

Eli Lilly and Company

Start Date

2/10/2026

Completion Date

4/1/2028

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Eloralintide

DRUG

Placebo

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Conditions

Sleep Apnea, ObstructiveObesityOverweight

Locations

Cullman Clinical Trials

Cullman, Alabama 35055

United States

Ark Clinical Research

Long Beach, California 90815

United States

Collaborative Neuroscience Research, LLC

Los Alamitos, California 90720

United States

Artemis Institute for Clinical Research

Riverside, California 92503

United States

Care Access - Aurora

Aurora, Colorado 80012

United States

Flourish Research - Miami, LLC

Miami, Florida 33135

United States

PharmaDev Clinical Research Institute, LLC

Miami, Florida 33176

United States

Emerald Coast Neurology - Airport Boulevard

Pensacola, Florida 32504

United States

Teak Research Consults

Lawrenceville, Georgia 30043

United States

EBGS Clinical Research Center

Snellville, Georgia 30078

United States

Care Access - Shreveport 2

Shreveport, Louisiana 71105

United States

Flourish Research - Bowie

Bowie, Maryland 20715

United States

Revive Research Institute, Inc.

Southfield, Michigan 48075

United States

Headlands Research-Twin Cities

Maplewood, Minnesota 55109

United States

Clayton Sleep Institute - St. Louis - Tesson Ferry Road

St Louis, Missouri 63123

United States

Palm Research Center Tenaya

Las Vegas, Nevada 89128

United States

The Sleep Spot - Maimonides

Albuquerque, New Mexico 87107

United States

Rochester Clinical Research - Buffalo

Buffalo, New York 14127

United States

CTI Clinical Research Center

Cincinnati, Ohio 45212

United States

Bogan Sleep Consultants

Columbia, South Carolina 29201

United States

FutureSearch Trials of Neurology

Austin, Texas 78731

United States

Sleep Therapy Research Center

San Antonio, Texas 78229

United States

Consano Clinical Research, LLC

Shavano Park, Texas 78231

United States

Cicemo Srl

Buenos Aires, 1424

Argentina

Stat Research S.A.

Buenos Aires, C1023AAB

Argentina

Centro de Investigaciones Metabólicas (CINME)

Buenos Aires, C1056ABI

Argentina

Centro Médico Viamonte

Buenos Aires, C1120AAC

Argentina

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

Buenos Aires, C1425AGC

Argentina

Fundación Respirar

Buenos Aires, C1426ABP

Argentina

Centro de Investigaciones Clínicas Baigorria

Granadero Baigorria, 2152

Argentina

Instituto Médico Río Cuarto

Río Cuarto, X5800AEV

Argentina

INECO Neurociencias Oroño

Rosario, 2000

Argentina

Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica

Rosario, 2000

Argentina

CIMER Centro Integral de Medicina Respiratoria

San Miguel de Tucumán, 4000

Argentina

Centro de Salud e Investigaciones Médicas

Santa Rosa, L6300

Argentina

Nightingale Research

Adelaide, 5000

Australia

Flinders University

Bedford Park, 5042

Australia

Box Hill Hospital

Box Hill, 3128

Australia

Core Research Group

Brisbane, 4064

Australia

Austin Health - Repatriation Hospital

Heidelberg West, 3081

Australia

CDH Research Institute Pty Ltd

Maroochydore, 4558

Australia

Gold Coast University Hospital

Southport, 4215

Australia

TrialsWest - Spearwood

Spearwood, 6163

Australia

Instituto de Pesquisa clinica de Campinas

Campinas, 13060-080

Brazil

Centro de Pesquisa Clínica de Marília - CPCLIM

Marília, 17504-072

Brazil

Núcleo de Pesquisa Clínica do Rio Grande do Sul

Porto Alegre, 90430-001

Brazil

CEMER - Centro Médico do Recife

Recife, 51110-160

Brazil

Ruschel Medicina e Pesquisa Clínica

Rio de Janeiro, 22270-060

Brazil

Prognosis Pesquisa Clínica

Santo André, 09040-010

Brazil

CPHosp Medicina, Ensino e Pesquisa (CPQuali)

São Paulo, 01228-000

Brazil

BR Trials - Ensaios Clinicos e Consultoria

São Paulo, 01236030

Brazil

CEPIC - Centro Paulista de Investigação Clínica

São Paulo, 04266-010

Brazil

Incor - Instituto do Coracao

São Paulo, 05403-900

Brazil

MyCliniResearch, Inc.

Calgary, T2Z 3R6

Canada

Alpha Recherche Clinique - Lévis

Lévis, G6V 0C9

Canada

Alpha Recherche Clinique

Québec, G2J 0C4

Canada

C.I.C. Joliette

Saint-Charles-Borromée, J6E 2B4

Canada

C.I.C. Saint-Laurent

Saint-Laurent, H4R 3C8

Canada

Maple Leaf Research

Toronto, M5G 1K2

Canada

C.I.C. Mauricie inc.

Trois-Rivières, G8T 7A1

Canada

China-Japan Friendship Hospital

Beijing, 100029

China

The First Hospital of Jilin University

Changchun, 130021

China

The Second Hospital of Jilin University

Changchun, 130041

China

The Third Xiangya Hospital of Central South University

Changsha, 410013

China

Sichuan Provincial People's Hospital

Chengdu, 610072

China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, 400016

China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, 510360

China

The Second People's Hospital of Hefei

Hefei, 230011

China

The First People's Hospital of Yunnan Province

Kunming, 650034

China

Gansu Provincial Hospital

Lanzhou, 730000

China

The First Affiliated Hospital of Henan University of Science &Technology

Luoyang Shi, 471003

China

The Second Affiliated Hospital of Nanchang University

Nanchang, 330006

China

Jiangxi Provincial People's Hospital

Nanchang, 330038

China

Nanjing First Hospital

Nanjing, 210006

China

The Second Affiliated Hospital of Guangxi Medical University

Nanning, 053007

China

Ningbo First Hospital

Ningbo, 315010

China

Shanghai Sixth People's Hospital

Shanghai, 200030

China

Shanghai East Hospital

Shanghai, 200120

China

ShenZhen People's Hospital

Shenzhen, 518020

China

Shenzhen Hospital of Southern Medical University

Shenzhen, 518110

China

The Second Affiliated Hospital of Soochow University

Suzhou, 215004

China

Wuxi People's Hospital

Wuxi, 214023

China

Xianyang Hospital of Yan'an University

Xianyang, 712000

China

CIMS Studienzentrum Bamberg

Bamberg, 96049

Germany

Advanced Sleep Research

Berlin, 10117

Germany

InnoDiab Forschung Gmbh

Essen, 45136

Germany

Siteworks GmbH - Hannover

Hanover, 30449

Germany

Siteworks - Karlsruhe

Karlsruhe, 76137

Germany

Universitätsklinikum Marburg

Marburg, 35033

Germany

RED-Institut GmbH

Oldenburg, 23758

Germany

Somni bene

Schwerin, 19053

Germany

SDS Tuberculosis Research Center & Rajiv Gandhi Institute of Chest Diseases

Bengaluru, 560029

India

St. Johns Medical College Hospital

Bengaluru, 560034

India

Utkal Institute of Medical Sciences and Hospital

Bhubaneswar, 751021

India

Endolife Speciality Hospitals

Guntur, 522001

India

KRIMS Hospital

Nagpur, 440010

India

All India Institute of Medical Sciences

New Delhi, 110029

India

Sir Ganga Ram Hospital

New Delhi, 110060

India

Deenanath Mangeshkar Hospital & Research Centre

Pune, 411004

India

All India Institute of Medical Sciences

Raipur, 492099

India

All India Institute of Medical Sciences - Rishikesh

Rishikesh, 249203

India

Bhakti Vedanta Hospital and Research Institute

Thane, 401107

India

Rhythm Heart Institute - A Unit of SLPL

Vadodara, 390022

India

Juntendo University Hospital

Bunkyō City, 113-8431

Japan

Fukuoka University Hospital

Fukuoka, 814-0180

Japan

Social Medical Corporation Sokujinkai Sleep and Mental Health Clinic - Kitahiroshima

Kitahiroshima, 061-1121

Japan

Kirigaokatsuda Hospital

Kitakyushu, 802-0052

Japan

Toranomon Hospital

Minatoku, 105-8470

Japan

Osaka Kaisei Hospital

Osaka, 532-0003

Japan

KKR Sapporo Medical Center

Sapporo, 062-0931

Japan

Yoyogi Sleep Disorder Center

Shibuya-ku, 151-0053

Japan

Nakamura Clinic

Urasoe, 901-2132

Japan

RESM Respiratory and Sleep Medical Care Clinic

Yokohama, 222-0033

Japan

Korea University Ansan Hospital

Ansan-si, 15355

South Korea

Severance Hospital, Yonsei University Health System

Seoul, 03722

South Korea

Asan Medical Center

Seoul, 05505

South Korea

Korea University Guro Hospital

Seoul, 08308

South Korea

Hospital Universitario de Guadalajara

Guadalajara, 19002

Spain

Hospital Universitari de Santa Maria

Lleida, 25198

Spain

Hospital San Pedro

Logroño, 26006

Spain

Hospital Universitario Ramón y Cajal

Madrid, 28034

Spain

Instituto de Investigaciones del Sueño

Madrid, 28036

Spain

Hospital Universitario La Paz

Madrid, 28046

Spain

Hospital Universitario Virgen de la Victoria

Málaga, 29010

Spain

Hospital Quiron Infanta Luisa

Seville, 41010

Spain

Hospital Universitario Virgen Del Rocio

Seville, 41013

Spain

China Medical University Hospital

Taichung, 40447

Taiwan

National Cheng-Kung Uni. Hosp.

Tainan, 704

Taiwan

Chang Gung Medical Foundation-Linkou Branch

Taoyuan, 333

Taiwan