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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Eli Lilly and Company • ClinicalTrials.gov ID: NCT07369011

Registry updated: 2026-10-08
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Description

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.

Interventions

  • Eloralintide (Drug)
    Administered SC
  • Placebo (Drug)
    Administered SC

Eligibility 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

Conditions

Sleep Apnea, Obstructive Obesity Overweight

Locations

  • 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
  • Bogan Sleep Consultants — Columbia, South Carolina, United States
  • FutureSearch Trials of Neurology — Austin, Texas, United States
  • Sleep Therapy Research Center — San Antonio, Texas, United States
  • Consano Clinical Research, LLC — Shavano Park, Texas, United States
  • Nightingale Research — Adelaide, Australia
  • Flinders University — Bedford Park, Australia
  • Box Hill Hospital — Box Hill, Australia
  • Core Research Group — Brisbane, Australia
  • Austin Health - Repatriation Hospital — Heidelberg West, Australia
  • CDH Research Institute Pty Ltd — Maroochydore, Australia
  • Gold Coast University Hospital — Southport, Australia
  • TrialsWest - Spearwood — Spearwood, Australia
  • Instituto de Pesquisa clinica de Campinas — Campinas, Brazil
  • Centro de Pesquisa Clínica de Marília - CPCLIM — Marília, Brazil
  • Núcleo de Pesquisa Clínica do Rio Grande do Sul — Porto Alegre, Brazil
  • CEMER - Centro Médico do Recife — Recife, Brazil
  • Ruschel Medicina e Pesquisa Clínica — Rio de Janeiro, Brazil
  • Prognosis Pesquisa Clínica — Santo André, Brazil
  • CPHosp Medicina, Ensino e Pesquisa (CPQuali) — São Paulo, Brazil
  • BR Trials - Ensaios Clinicos e Consultoria — São Paulo, Brazil
  • CEPIC - Centro Paulista de Investigação Clínica — São Paulo, Brazil
  • Incor - Instituto do Coracao — São Paulo, Brazil
  • MyCliniResearch, Inc. — Calgary, Canada
  • Alpha Recherche Clinique - Lévis — Lévis, Canada
  • Alpha Recherche Clinique — Québec, Canada
  • C.I.C. Saint-Laurent — Saint-Laurent, Canada
  • Maple Leaf Research — Toronto, Canada
  • C.I.C. Mauricie inc. — Trois-Rivières, Canada
  • China-Japan Friendship Hospital — Beijing, China
  • The First Hospital of Jilin University — Changchun, China
  • The Second Hospital of Jilin University — Changchun, China
  • The Third Xiangya Hospital of Central South University — Changsha, China
  • Sichuan Provincial People's Hospital — Chengdu, China
  • The First Affiliated Hospital of Chongqing Medical University — Chongqing, China
  • The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, China
  • The Second People's Hospital of Hefei — Hefei, China
  • The First People's Hospital of Yunnan Province — Kunming, China
  • Gansu Provincial Hospital — Lanzhou, China
  • The First Affiliated Hospital of Henan University of Science &Technology — Luoyang Shi, China
  • Jiangxi Provincial People's Hospital — Nanchang, China
  • Nanjing First Hospital — Nanjing, China
  • The Second Affiliated Hospital of Guangxi Medical University — Nanning, China
  • Ningbo First Hospital — Ningbo, China
  • Shanghai Sixth People's Hospital — Shanghai, China
  • Shanghai East Hospital — Shanghai, China
  • ShenZhen People's Hospital — Shenzhen, China
  • Shenzhen Hospital of Southern Medical University — Shenzhen, China
  • The Second Affiliated Hospital of Soochow University — Suzhou, China
  • Wuxi People's Hospital — Wuxi, China
  • Xianyang Hospital of Yan'an University — Xianyang, China
  • CIMS Studienzentrum Bamberg — Bamberg, Germany
  • Advanced Sleep Research — Berlin, Germany
  • InnoDiab Forschung Gmbh — Essen, Germany
  • Siteworks GmbH - Hannover — Hanover, Germany
  • Siteworks GmbH - Zentrum für klinische Studien Karlsruhe — Karlsruhe, Germany
  • Universitätsklinikum Marburg — Marburg, Germany
  • RED-Institut GmbH — Oldenburg, Germany
  • Somni bene — Schwerin, Germany
  • SDS Tuberculosis Research Center & Rajiv Gandhi Institute of Chest Diseases — Bengaluru, India
  • St. Johns Medical College Hospital — Bengaluru, India
  • Utkal Institute of Medical Sciences and Hospital — Bhubaneswar, India
  • Endolife Speciality Hospitals — Guntur, India
  • KRIMS Hospital — Nagpur, India
  • All India Institute of Medical Sciences — New Delhi, India
  • Sir Ganga Ram Hospital — New Delhi, India
  • Deenanath Mangeshkar Hospital & Research Centre — Pune, India
  • All India Institute of Medical Sciences — Raipur, India
  • All India Institute of Medical Sciences - Rishikesh — Rishikesh, India
  • Bhakti Vedanta Hospital and Research Institute — Thane, India
  • Rhythm Heart Institute - A Unit of SLPL — Vadodara, India
  • Juntendo University Hospital — Bunkyō City, Japan
  • Fukuoka University Hospital — Fukuoka, Japan
  • Social Medical Corporation Sokujinkai Sleep and Mental Health Clinic - Kitahiroshima — Kitahiroshima, Japan
  • Kirigaokatsuda Hospital — Kitakyushu, Japan
  • Toranomon Hospital — Minatoku, Japan
  • Osaka Kaisei Hospital — Osaka, Japan
  • KKR Sapporo Medical Center — Sapporo, Japan
  • Yoyogi Sleep Disorder Center — Shibuya-ku, Japan
  • Nakamura Clinic — Urasoe, Japan
  • RESM Respiratory and Sleep Medical Care Clinic — Yokohama, Japan
  • Korea University Ansan Hospital — Ansan-si, South Korea
  • Severance Hospital, Yonsei University Health System — Seoul, South Korea
  • Asan Medical Center — Seoul, South Korea
  • Korea University Guro Hospital — Seoul, South Korea
  • Hospital Universitario de Guadalajara — Guadalajara, Spain
  • Hospital Universitari de Santa Maria — Lleida, Spain
  • Hospital San Pedro — Logroño, Spain
  • Hospital Universitario Ramón y Cajal — Madrid, Spain
  • Instituto de Investigaciones del Sueño — Madrid, Spain
  • Hospital Universitario La Paz — Madrid, Spain
  • Hospital Universitario Virgen de la Victoria — Málaga, Spain
  • Hospital Quiron Infanta Luisa — Seville, Spain
  • Hospital Universitario Virgen Del Rocio — Seville, Spain
  • China Medical University Hospital — Taichung, Taiwan
  • National Cheng-Kung Uni. Hosp. — Tainan, Taiwan
  • Chang Gung Medical Foundation-Linkou Branch — Taoyuan, Taiwan
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record