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NCT07369011RecruitingPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 4 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
800 (estimated)
First submitted
23 Jan 2026
Start date
10 Feb 2026
Primary completion date
Mar 2028
Lead sponsor
Eli Lilly and Company
Diseases
Obesity
NCT number
NCT07369011
EU CT number
2025-523769-11-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 800
  • From 10 Feb 2026 to the primary completion date, Mar 2028
  • 115 sites in 11 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 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 taken medications or alternative remedies intended for weight loss within 90 days of screening

Other illness

  • Have type 1 diabetes, type 2 diabetes, or any other type of diabetes
  • Have a history or diagnosis of New York Heart Association Functional Classification Class IV congestive heart failure

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (115)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Nightingale Research
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AdelaideAustraliaRecruiting
Flinders University
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Bedford ParkAustraliaRecruiting
Box Hill Hospital
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Box HillAustraliaRecruiting
Core Research Group
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BrisbaneAustraliaRecruiting
Austin Health - Repatriation Hospital
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Heidelberg WestAustraliaRecruiting
CDH Research Institute Pty Ltd
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MaroochydoreAustraliaRecruiting
Gold Coast University Hospital
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SouthportAustraliaRecruiting
TrialsWest - Spearwood
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SpearwoodAustraliaRecruiting
Instituto de Pesquisa Clínica de Campinas
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CampinasBrazilSuspended
Centro de Pesquisa Clínica de Marília - CPCLIM
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MaríliaBrazilSuspended
Nucleo de Pesquisa Clínica do Rio Grande do Sul
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Porto AlegreBrazilSuspended
CEMER - Centro Médico do Recife
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RecifeBrazilSuspended
Ruschel Medicina e Pesquisa Clínica
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Rio de JaneiroBrazilSuspended
Prognosis Pesquisa Clínica
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Santo AndréBrazilSuspended
BR Trials-Ensaios Clinicos e Consultoria
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São PauloBrazilSuspended
CPHosp Medicina, Ensino e Pesquisa (CPQuali)
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São PauloBrazilSuspended
Incor - Instituto do Coracao
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São PauloBrazilSuspended
CEPIC - Centro Paulista de Investigação Clínica
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São PauloBrazilSuspended
MyCliniResearch, Inc.
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CalgaryCanadaRecruiting
Alpha Recherche Clinique - Lévis
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LévisCanadaRecruiting
Alpha Recherche Clinique
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QuébecCanadaRecruiting
C.I.C. Saint-Laurent
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Saint-LaurentCanadaRecruiting
Maple Leaf Research
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TorontoCanadaRecruiting
C.I.C. Mauricie inc.
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Trois-RivièresCanadaRecruiting
China-Japan Friendship Hospital
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BeijingChinaRecruiting
The Second Hospital of Jilin University
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ChangchunChinaRecruiting
The First Hospital of Jilin University
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ChangchunChinaRecruiting
The Third Xiangya Hospital of Central South University
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ChangshaChinaRecruiting
Sichuan Provincial People's Hospital
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ChengduChinaRecruiting
The First Affiliated Hospital of Chongqing Medical University
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ChongqingChinaRecruiting
The First Affiliated Hospital of Guangzhou Medical University
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GuangzhouChinaRecruiting
The Second People's Hospital of Hefei
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HefeiChinaNot yet recruiting
The First People's Hospital of Yunnan Province
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KunmingChinaRecruiting
Gansu Provincial Hospital
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LanzhouChinaRecruiting
The First Affiliated Hospital of Henan University of Science &Technology
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Luoyang ShiChinaRecruiting
Jiangxi Provincial People's Hospital
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NanchangChinaRecruiting
Nanjing First Hospital
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NanjingChinaRecruiting
The Second Affiliated Hospital of Guangxi Medical University
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NanningChinaRecruiting
Ningbo First Hospital
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NingboChinaRecruiting
Shanghai Sixth People's Hospital
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ShanghaiChinaNot yet recruiting
Shanghai East Hospital
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ShanghaiChinaRecruiting
Shenzhen Hospital of Southern Medical University
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ShenzhenChinaRecruiting
Shenzhen People's Hospital
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ShenzhenChinaRecruiting
The Second Affiliated Hospital of Soochow University
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SuzhouChinaRecruiting
Wuxi People's Hospital
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WuxiChinaRecruiting
Xianyang Hospital of Yan'an University
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XianyangChinaRecruiting
CIMS Studienzentrum Bamberg
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BambergGermanyRecruiting
Advanced Sleep Research
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BerlinGermanyRecruiting
InnoDiab Forschung Gmbh
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EssenGermanyRecruiting
Siteworks GmbH Hannover
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HanoverGermanyRecruiting
Siteworks GmbH - Zentrum für klinische Studien Karlsruhe
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KarlsruheGermanyRecruiting
Universitätsklinikum Marburg
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MarburgGermanyRecruiting
RED-Institut GmbH
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OldenburgGermanyRecruiting
Somni bene
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SchwerinGermanyRecruiting
Hospital Universitario de Guadalajara
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GuadalajaraSpainRecruiting
Hospital Universitari de Santa Maria
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LleidaSpainRecruiting
Hospital San Pedro
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LogroñoSpainRecruiting
Instituto de Investigaciones del Sueno
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MadridSpainRecruiting
Hospital Universitario La Paz
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MadridSpainRecruiting
Hospital Universitario Ramón y Cajal
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MadridSpainRecruiting
Hospital Universitario Virgen de la Victoria
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MálagaSpainRecruiting
Hospital Quiron Infanta Luisa
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SevilleSpainRecruiting
Hospital Universitario Virgen del Rocio
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SevilleSpainRecruiting
SDS Tuberculosis Research Center & Rajiv Gandhi Institute of Chest Diseases
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BengaluruIndiaNot yet recruiting
St. Johns Medical College Hospital
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BengaluruIndiaNot yet recruiting
Utkal Institute of Medical Sciences and Hospital
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BhubaneswarIndiaRecruiting
Endolife Speciality Hospitals
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GunturIndiaRecruiting
KRIMS Hospital
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NagpurIndiaRecruiting
Sir Ganga Ram Hospital
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New DelhiIndiaRecruiting
All India Institute of Medical Sciences
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New DelhiIndiaRecruiting
Deenanath Mangeshkar Hospital & Research Centre
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PuneIndiaRecruiting
All India Institute of Medical Sciences
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RaipurIndiaRecruiting
All India Institute of Medical Sciences, Rishikesh
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RishikeshIndiaRecruiting
Bhakti Vedanta Hospital and Research Institute
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ThaneIndiaRecruiting
Rhythm Heart Institute - A Unit of SLPL
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VadodaraIndiaSuspended
Juntendo University Hospital
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Bunkyō CityJapanRecruiting
Fukuoka University Hospital
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FukuokaJapanRecruiting
Social Medical Corporation Sokujinkai Sleep and Mental Health Clinic - Kitahiroshima
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KitahiroshimaJapanRecruiting
Kirigaokatsuda Hospital
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KitakyushuJapanRecruiting
Toranomon Hospital
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MinatokuJapanRecruiting
Osaka Kaisei Hospital
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OsakaJapanRecruiting
KKR Sapporo Medical Center
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SapporoJapanRecruiting
Yoyogi Sleep Disorder Center
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Shibuya-kuJapanRecruiting
Nakamura Clinic
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UrasoeJapanRecruiting
RESM Respiratory and Sleep Medical Care Clinic
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YokohamaJapanRecruiting
Korea University Ansan Hospital
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Ansan-siSouth KoreaRecruiting
Asan Medical Center
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SeoulSouth KoreaRecruiting
Korea University Guro Hospital
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SeoulSouth KoreaRecruiting
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaRecruiting
China Medical University Hospital
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TaichungTaiwanRecruiting
National Cheng-Kung Uni. Hosp.
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TainanTaiwanRecruiting
Chang Gung Medical Foundation-Linkou Branch
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TaoyuanTaiwanRecruiting
The Sleep Spot - Maimonides
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AlbuquerqueUnited StatesRecruiting
Care Access - Aurora
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AuroraUnited StatesRecruiting
FutureSearch Trials of Neurology
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AustinUnited StatesRecruiting
Flourish Research - Bowie
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BowieUnited StatesRecruiting
Rochester Clinical Research - Buffalo
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BuffaloUnited StatesRecruiting
CTI Clinical Research Center
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CincinnatiUnited StatesRecruiting
Bogan Sleep Consultants
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ColumbiaUnited StatesRecruiting
Cullman Clinical Trials
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CullmanUnited StatesRecruiting
Palm Research Center Tenaya
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Las VegasUnited StatesRecruiting
Teak Research Consults
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LawrencevilleUnited StatesRecruiting
Ark Clinical Research
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Long BeachUnited StatesRecruiting
Collaborative Neuroscience Research, LLC
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Los AlamitosUnited StatesRecruiting
Headlands Research-Twin Cities
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MaplewoodUnited StatesRecruiting
PharmaDev Clinical Research Institute, LLC
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MiamiUnited StatesRecruiting
Flourish Research - Miami, LLC
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MiamiUnited StatesRecruiting
Emerald Coast Neurology - Airport Boulevard
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PensacolaUnited StatesRecruiting
Artemis Institute for Clinical Research
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RiversideUnited StatesRecruiting
Sleep Therapy Research Center
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San AntonioUnited StatesRecruiting
Consano Clinical Research, LLC
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Shavano ParkUnited StatesRecruiting
Care Access - Shreveport 2
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ShreveportUnited StatesRecruiting
EBGS Clinical Research Center
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SnellvilleUnited StatesRecruiting
Revive Research Institute, Inc
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SouthfieldUnited StatesRecruiting
Clayton Sleep Institute - St. Louis - Tesson Ferry Road
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St LouisUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.