A Study of Eloralintide (LY3841136) in Participants With Obstructive Sleep Apnea and Obesity or Overweight
ENLIGHTEN-3
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
5 other identifiers
interventional
800
12 countries
122
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2026
122 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2026
CompletedFirst Posted
Study publicly available on registry
January 27, 2026
CompletedStudy Start
First participant enrolled
February 10, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
March 20, 2026
March 1, 2026
2.1 years
January 23, 2026
March 19, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Percent Change from Baseline in Body Weight
Baseline, Week 64
Change from Baseline in Apnea-Hypopnea Index (AHI)
Baseline, Week 64
Secondary Outcomes (18)
Change from Baseline in Systolic Blood Pressure (SBP)
Baseline, Week 64
Percent Change from Baseline in Triglycerides
Baseline, Week 64
Percent Change from Baseline in High Sensitivity C-Reactive Protein (hsCRP)
Baseline, Week 64
Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Sleep-Related Impairment 8a T-Score
Baseline, Week 64
Achievement of AHI <5 or AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤ 10
Baseline, Week 64
- +13 more secondary outcomes
Study Arms (4)
Eloralintide (YSA1)
EXPERIMENTALParticipants will receive eloralintide subcutaneously (SC)
Placebo (YSA1)
PLACEBO COMPARATORParticipants will receive placebo SC
Eloralintide (YSA2)
EXPERIMENTALParticipants will receive eloralintide SC
Placebo (YSA2)
PLACEBO COMPARATORParticipants will receive placebo SC
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (122)
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
Heritage Valley Multispecialty Group, Inc
Beaver, Pennsylvania, 15009, 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
Woolcock Institute of Medical Research
Macquarie Park, 2113, 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
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
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
Gansu Provincial Hospital
Lanzhou, 730000, China
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang Shi, 471003, China
Jiangxi Provincial People's Hospital
Nanchang, 330006, China
The Second Affiliated Hospital of Nanchang University
Nanchang, 330006, China
The Second Affiliated Hospital of Guangxi Medical University
Nanning, 053007, China
Shanghai Sixth People's Hospital
Shanghai, 200030, China
ShenZhen People's Hospital
Shenzhen, 518020, China
The Third Hospital of Hebei Medical University
Shijiazhuang, 050051, China
The Second Affiliated Hospital of Soochow University
Suzhou, 215004, China
Wuxi People's Hospital
Wuxi, 214023, 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
Seoul National University Bundang Hospital
Seongnam, 13620, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, 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 District, 333, Taiwan
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2026
First Posted
January 27, 2026
Study Start
February 10, 2026
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
April 1, 2028
Last Updated
March 20, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.