A Study of Eloralintide (LY3841136) in Participants With Obstructive Sleep Apnea and Obesity or Overweight (ENLIGHTEN-3)

August 21, 2026 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

800

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • Australia
      • Adelaide, Australia, 5000
        • Recruiting
        • Nightingale Research
        • Principal Investigator:
          • Andrew Hamilton
      • Bedford Park, Australia, 5042
        • Recruiting
        • Flinders University
        • Principal Investigator:
          • Danny Eckert
        • Contact:
          • Phone Number: 61 8 74219780
      • Box Hill, Australia, 3128
        • Recruiting
        • Box Hill Hospital
        • Principal Investigator:
          • Ming Li Yee
      • Brisbane, Australia, 4064
        • Recruiting
        • Core Research Group
        • Contact:
          • Phone Number: 61738765688
        • Principal Investigator:
          • David Colquhoun
      • Heidelberg West, Australia, 3081
        • Recruiting
        • Austin Health - Repatriation Hospital
        • Contact:
          • Phone Number: 0394962160
        • Principal Investigator:
          • Elif Ekinci
      • Maroochydore, Australia, 4558
        • Recruiting
        • CDH Research Institute Pty Ltd
        • Principal Investigator:
          • Hansjoerg Seltenreich
        • Contact:
          • Phone Number: 07 5408 0900
      • Southport, Australia, 4215
        • Recruiting
        • Gold Coast University Hospital
        • Contact:
          • Phone Number: 0432143849
        • Principal Investigator:
          • George Tay
      • Spearwood, Australia, 6163
        • Recruiting
        • TrialsWest - Spearwood
        • Contact:
          • Phone Number: 61893121931
        • Principal Investigator:
          • Peter Bremner
  • Brazil
      • Campinas, Brazil, 13060-080
        • Suspended
        • Instituto de Pesquisa Clínica de Campinas
      • Marília, Brazil, 17504-072
        • Suspended
        • Centro de Pesquisa Clínica de Marília - CPCLIM
      • Porto Alegre, Brazil, 90430-001
        • Suspended
        • Nucleo de Pesquisa Clínica do Rio Grande do Sul
      • Recife, Brazil, 51110-160
        • Suspended
        • CEMER - Centro Médico do Recife
      • Rio de Janeiro, Brazil, 22270-060
        • Suspended
        • Ruschel Medicina e Pesquisa Clínica
      • Santo André, Brazil, 09040-010
        • Suspended
        • Prognosis Pesquisa Clínica
      • São Paulo, Brazil, 01228-000
        • Suspended
        • CPHosp Medicina, Ensino e Pesquisa (CPQuali)
      • São Paulo, Brazil, 01236030
        • Suspended
        • BR Trials - Ensaios Clinicos e Consultoria
      • São Paulo, Brazil, 04266-010
        • Suspended
        • CEPIC - Centro Paulista de Investigacao Clinica
      • São Paulo, Brazil, 05403-900
        • Suspended
        • Incor - Instituto do Coracao
  • Canada
      • Calgary, Canada, T2Z 3R6
        • Recruiting
        • MyCliniResearch, Inc.
        • Contact:
          • Phone Number: 5873320600
        • Principal Investigator:
          • Wilfred Alonso
      • Lévis, Canada, G6V 0C9
        • Recruiting
        • Alpha Recherche Clinique - Lévis
        • Contact:
          • Phone Number: 418-380-1112
        • Principal Investigator:
          • Dominique Deschênes
      • Québec, Canada, G2J 0C4
        • Recruiting
        • ALPHA Recherche Clinique
        • Principal Investigator:
          • Nancy Labrecque
      • Saint-Laurent, Canada, H4R 3C8
        • Recruiting
        • C.I.C. Saint-Laurent
        • Contact:
          • Phone Number: 8193731128
        • Principal Investigator:
          • Emilie Millaire
      • Toronto, Canada, M5G 1K2
        • Recruiting
        • Maple Leaf Research
        • Principal Investigator:
          • Graham Smith
        • Contact:
          • Phone Number: 4164657936
      • Trois-Rivières, Canada, G8T 7A1
        • Recruiting
        • C.I.C. Mauricie inc.
        • Principal Investigator:
          • Pierre-Alexandre Menard
  • China
      • Beijing, China, 100029
        • Not yet recruiting
        • China-Japan Friendship Hospital
        • Principal Investigator:
          • Xiaolei Zhang
      • Changchun, China, 130021
        • Not yet recruiting
        • The First Hospital of Jilin University
        • Contact:
          • Phone Number: 15843081103
        • Principal Investigator:
          • Guixia Wang
      • Changchun, China, 130041
        • Not yet recruiting
        • The Second Hospital of Jilin University
        • Principal Investigator:
          • Hanqing Cai
      • Changsha, China, 410013
        • Not yet recruiting
        • The Third Xiangya Hospital of Central South University
        • Principal Investigator:
          • Ping Jin
      • Chengdu, China, 610072
        • Not yet recruiting
        • Sichuan Provincial People's Hospital
        • Principal Investigator:
          • Yan Yang
      • Chongqing, China, 400016
        • Not yet recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Principal Investigator:
          • Tao Chen
      • Guangzhou, China, 510360
        • Not yet recruiting
        • The First Affiliated Hospital of Guangzhou Medical University
        • Principal Investigator:
          • Nuofu Zhang
      • Hefei, China, 230011
        • Not yet recruiting
        • The Second People's Hospital of Hefei
        • Principal Investigator:
          • Jun Ye
        • Contact:
          • Phone Number: 86-13956099720
      • Kunming, China, 650034
        • Not yet recruiting
        • The First People's Hospital of Yunnan Province
        • Contact:
          • Phone Number: 18908710522
        • Principal Investigator:
          • Yikun Zhou
      • Lanzhou, China, 730000
        • Not yet recruiting
        • Gansu Provincial Hospital
        • Principal Investigator:
          • Peilin Hui
      • Luoyang Shi, China, 471003
        • Not yet recruiting
        • The First Affiliated Hospital of Henan University of Science &Technology
        • Principal Investigator:
          • Hongwei Jiang
        • Contact:
          • Phone Number: 13653880139
      • Nanchang, China, 330038
        • Not yet recruiting
        • Jiangxi Provincial People's Hospital
        • Principal Investigator:
          • Zongyou Cheng
        • Contact:
          • Phone Number: 13767035719
      • Nanjing, China, 210006
        • Not yet recruiting
        • Nanjing First Hospital
        • Principal Investigator:
          • Qian Li
      • Nanning, China, 053007
        • Not yet recruiting
        • The Second Affiliated Hospital of Guangxi Medical University
        • Principal Investigator:
          • xiaoyu Tan
      • Ningbo, China, 315010
        • Not yet recruiting
        • Ningbo First Hospital
        • Contact:
          • Phone Number: 13757426626
        • Principal Investigator:
          • Li Li
      • Shanghai, China, 200120
        • Not yet recruiting
        • Shanghai East Hospital
        • Principal Investigator:
          • You Yin
      • Shanghai, China, 200030
        • Not yet recruiting
        • Shanghai Sixth People's Hospital
        • Principal Investigator:
          • Shankai Yin
      • Shenzhen, China, 518020
        • Not yet recruiting
        • Shenzhen People's Hospital
        • Contact:
          • Phone Number: +8613510099301
        • Principal Investigator:
          • Hanrong Cheng
      • Shenzhen, China, 518110
        • Not yet recruiting
        • Shenzhen Hospital of Southern Medical University
        • Principal Investigator:
          • Lingling Xu
      • Suzhou, China, 215004
        • Not yet recruiting
        • The Second Affiliated Hospital of Soochow University
        • Principal Investigator:
          • Rui Chen
      • Wuxi, China, 214023
        • Not yet recruiting
        • Wuxi People's Hospital
        • Principal Investigator:
          • Xiaowei ZHU
        • Contact:
          • Phone Number: 86-13812050092
      • Xianyang, China, 712000
        • Not yet recruiting
        • Xianyang Hospital of Yan'an University
        • Principal Investigator:
          • Wei Zhang
  • Germany
      • Bamberg, Germany, 96049
        • Recruiting
        • CIMS Studienzentrum Bamberg
        • Principal Investigator:
          • Johannes Haas
        • Contact:
          • Phone Number: 0049951 51099580
      • Berlin, Germany, 10117
        • Recruiting
        • Advanced Sleep Research
        • Contact:
          • Phone Number: 493028886770
        • Principal Investigator:
          • Katharina Lederer
      • Essen, Germany, 45136
        • Recruiting
        • InnoDiab Forschung GmbH
        • Principal Investigator:
          • Thomas Schürholz
        • Contact:
          • Phone Number: 49 201 89942100
      • Hanover, Germany, 30449
        • Recruiting
        • Siteworks GmbH - Hannover
        • Contact:
          • Phone Number: +4951151524747
        • Principal Investigator:
          • Ulrike Lengler
      • Karlsruhe, Germany, 76137
        • Recruiting
        • Siteworks - Karlsruhe
        • Contact:
          • Phone Number: 0049 721 619004 90
        • Principal Investigator:
          • Julia Chevts
      • Marburg, Germany, 35033
        • Recruiting
        • Universitätsklinikum Marburg
        • Contact:
          • Phone Number: 004964215862777
        • Principal Investigator:
          • Christian Viniol
      • Oldenburg, Germany, 23758
        • Recruiting
        • RED-Institut GmbH
        • Principal Investigator:
          • Thomas Schaum
        • Contact:
          • Phone Number: 0049436150630128
      • Schwerin, Germany, 19053
        • Recruiting
        • Somni bene
        • Contact:
          • Phone Number: 0049 385207980
        • Principal Investigator:
          • Heike Benes
  • India
      • Bengaluru, India, 560029
        • Not yet recruiting
        • SDS Tuberculosis Research Center & Rajiv Gandhi Institute of Chest Diseases
        • Principal Investigator:
          • Akshata S
        • Contact:
          • Phone Number: 9113030135
      • Bengaluru, India, 560034
        • Not yet recruiting
        • St. Johns Medical College Hospital
        • Principal Investigator:
          • UMA MAHESWARI KRISHNASWAMY
        • Contact:
          • Phone Number: +91 9483702412
      • Bhubaneswar, India, 751021
        • Recruiting
        • Utkal Institute of Medical Sciences and Hospital
        • Principal Investigator:
          • Satyajeet Sahoo
      • Guntur, India, 522001
        • Not yet recruiting
        • Endolife Speciality Hospitals
        • Principal Investigator:
          • GADDIPATI BABU
        • Contact:
          • Phone Number: 9849945577
      • Nagpur, India, 440010
        • Recruiting
        • KRIMS Hospital
        • Principal Investigator:
          • Ashok Arbat
      • New Delhi, India, 110060
        • Not yet recruiting
        • Sir Ganga Ram Hospital
        • Contact:
          • Phone Number: +919811051841
        • Principal Investigator:
          • Sanjay Manchanda
      • New Delhi, India, 110029
        • Recruiting
        • All India Institute of Medical Sciences
        • Principal Investigator:
          • Saurabh Mittal
      • Pune, India, 411004
        • Recruiting
        • Deenanath Mangeshkar Hospital & Research Centre
        • Principal Investigator:
          • Balasaheb Pawar
      • Raipur, India, 492099
        • Not yet recruiting
        • All India Institute of Medical Sciences
        • Principal Investigator:
          • Dibakar Sahu
      • Rishikesh, India, 249203
        • Not yet recruiting
        • All India Institute of Medical Sciences - Rishikesh
        • Contact:
          • Phone Number: +91-8890293424
        • Principal Investigator:
          • Lokesh Saini
      • Thane, India, 401107
        • Recruiting
        • Bhakti Vedanta Hospital and Research Institute
        • Principal Investigator:
          • Ajay Godse
        • Contact:
          • Phone Number: 079 6900 2222
      • Vadodara, India, 390022
        • Not yet recruiting
        • Rhythm Heart Institute - A Unit of SLPL
        • Contact:
          • Phone Number: 9925207953
        • Principal Investigator:
          • Tejas Kakkad
  • Japan
      • Bunkyō City, Japan, 113-8431
        • Recruiting
        • Juntendo University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Takatoshi Kasai
      • Fukuoka, Japan, 814-0180
        • Recruiting
        • Fukuoka University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Masaki Fujita
      • Kitahiroshima, Japan, 061-1121
        • Recruiting
        • Social Medical Corporation Sokujinkai Sleep and Mental Health Clinic - Kitahiroshima
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Jun Miura
      • Kitakyushu, Japan, 802-0052
        • Recruiting
        • Kirigaokatsuda Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Tetsuya Kawano
      • Minatoku, Japan, 105-8470
        • Recruiting
        • Toranomon Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Satoshi Kasagi
      • Osaka, Japan, 532-0003
        • Recruiting
        • Osaka Kaisei Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Saeko Osawa
      • Sapporo, Japan, 062-0931
        • Recruiting
        • KKR Sapporo Medical Center
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Hiroshi Saito
      • Shibuya-ku, Japan, 151-0053
        • Recruiting
        • Yoyogi Sleep Disorder Center
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Hideaki Nakayama
      • Urasoe, Japan, 901-2132
        • Recruiting
        • Nakamura Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Kei Nakamura
      • Yokohama, Japan, 222-0033
        • Recruiting
        • RESM Respiratory and Sleep Medical Care Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Ryutaro Shirahama
  • South Korea
      • Ansan-si, South Korea, 15355
        • Recruiting
        • Korea University Ansan Hospital
        • Principal Investigator:
          • Seung Hoon LEE
      • Seoul, South Korea, 03722
        • Not yet recruiting
        • Severance Hospital, Yonsei University Health System
        • Principal Investigator:
          • HYUNG-JU CHO
      • Seoul, South Korea, 05505
        • Recruiting
        • Asan Medical Center
        • Principal Investigator:
          • Yoo-Sam Chung
      • Seoul, South Korea, 08308
        • Not yet recruiting
        • Korea University Guro Hospital
        • Principal Investigator:
          • IL-HO PARK
  • Spain
      • Guadalajara, Spain, 19002
        • Recruiting
        • Hospital Universitario de Guadalajara
        • Contact:
          • Phone Number: 0034949209200
        • Principal Investigator:
          • Olga Mediano
      • Lleida, Spain, 25198
        • Recruiting
        • Hospital Universitari de Santa Maria
        • Principal Investigator:
          • Ferran Barbé Illa
        • Contact:
          • Phone Number: +34 (973) 70 53 72
      • Logroño, Spain, 26006
        • Recruiting
        • Hospital San Pedro
        • Contact:
          • Phone Number: 677151261
        • Principal Investigator:
          • Alejandra Roncero Lázaro
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramon Y Cajal
        • Principal Investigator:
          • Irene Cano Pumarega
      • Madrid, Spain, 28046
        • Not yet recruiting
        • Hospital Universitario La Paz
        • Contact:
          • Phone Number: +34917277011
        • Principal Investigator:
          • Francisco Fran
      • Madrid, Spain, 28036
        • Recruiting
        • Instituto de Investigaciones del Sueno
        • Contact:
          • Phone Number: 913454129
        • Principal Investigator:
          • Diego Garcia Borreguero
      • Málaga, Spain, 29010
        • Recruiting
        • Hospital Universitario Virgen de la Victoria
        • Principal Investigator:
          • Francisco Tinahones Madueno
        • Contact:
          • Phone Number: 951032734
      • Seville, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocío
        • Principal Investigator:
          • Candelaria Caballero Eraso
      • Seville, Spain, 41010
        • Not yet recruiting
        • Hospital Quiron Infanta Luisa
        • Contact:
          • Phone Number: 670502836
        • Principal Investigator:
          • MARGARITA RIVAS FERNANDEZ
  • Taiwan
      • Taichung, Taiwan, 40447
        • Recruiting
        • China Medical University Hospital
        • Contact:
          • Phone Number: +886975681003
        • Principal Investigator:
          • Liang-Wen Hang
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng-Kung Uni. Hosp.
        • Principal Investigator:
          • Yi-Ching Yang
        • Contact:
          • Phone Number: 886 62353535 ext 3985
      • Taoyuan, Taiwan, 333
        • Recruiting
        • Chang Gung Medical Foundation-Linkou Branch
        • Contact:
          • Phone Number: 033281200 ext.3966
        • Principal Investigator:
          • Hsueh-Yu Li
  • United States
    • Alabama
      • Cullman, Alabama, United States, 35055
        • Recruiting
        • Cullman Clinical Trials
        • Principal Investigator:
          • Randall Quinn
        • Contact:
          • Phone Number: 256-708-2826
    • California
      • Long Beach, California, United States, 90815
        • Recruiting
        • Ark Clinical Research
        • Principal Investigator:
          • Apinya Vutikullird
        • Contact:
          • Phone Number: 562-997-1000
      • Los Alamitos, California, United States, 90720
        • Recruiting
        • Collaborative Neuroscience Research, LLC
        • Contact:
          • Phone Number: 714-799-7799
        • Principal Investigator:
          • Steven Reynolds
      • Riverside, California, United States, 92503
        • Recruiting
        • Artemis Institute for Clinical Research
        • Contact:
          • Phone Number: 951-374-1190
        • Principal Investigator:
          • Jack Vu
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Recruiting
        • Care Access - Aurora
        • Principal Investigator:
          • Mauricio Waintrub
        • Contact:
          • Phone Number: 720-368-4865
    • Florida
      • Miami, Florida, United States, 33176
        • Recruiting
        • PharmaDev Clinical Research Institute, LLC
        • Contact:
          • Phone Number: 305-420-5636
        • Principal Investigator:
          • Edward Mezerhane
      • Miami, Florida, United States, 33135
        • Recruiting
        • Flourish Research - Miami, LLC
        • Contact:
          • Phone Number: 305-631-6704
        • Principal Investigator:
          • Mark Rosenthal
      • Pensacola, Florida, United States, 32504
        • Recruiting
        • Emerald Coast Neurology - Airport Boulevard
        • Contact:
          • Phone Number: 850-438-1136
        • Principal Investigator:
          • David Bear
    • Georgia
      • Lawrenceville, Georgia, United States, 30043
        • Recruiting
        • Teak Research Consults
        • Principal Investigator:
          • Kamar Alabi
      • Snellville, Georgia, United States, 30078
        • Recruiting
        • EBGS Clinical Research Center
        • Principal Investigator:
          • Aliu Sanni
        • Contact:
          • Phone Number: 770-729-4517
    • Louisiana
      • Shreveport, Louisiana, United States, 71105
        • Recruiting
        • Care Access - Shreveport 2
        • Principal Investigator:
          • David Green
        • Contact:
          • Phone Number: 318-209-3290
    • Maryland
      • Bowie, Maryland, United States, 20715
        • Recruiting
        • Flourish Research - Bowie
        • Principal Investigator:
          • BARBARA HUTCHINSON
        • Contact:
          • Phone Number: 410-824-1342
    • Michigan
      • Southfield, Michigan, United States, 48075
        • Recruiting
        • Revive Research Institute, Inc.
        • Principal Investigator:
          • Syed Raza
        • Contact:
          • Phone Number: 248-829-3103
    • Minnesota
      • Maplewood, Minnesota, United States, 55109
        • Recruiting
        • Headlands Research-Twin Cities
        • Principal Investigator:
          • Charlene McEvoy
    • Missouri
      • St Louis, Missouri, United States, 63123
        • Recruiting
        • Clayton Sleep Institute - St. Louis - Tesson Ferry Road
        • Contact:
          • Phone Number: 314-645-6005
        • Principal Investigator:
          • Joseph Ojile
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • Palm Research Center Tenaya
        • Contact:
          • Phone Number: 702-736-5161
        • Principal Investigator:
          • Samer Nakhle
    • New Mexico
      • Albuquerque, New Mexico, United States, 87107
        • Recruiting
        • The Sleep Spot - Maimonides
        • Contact:
          • Phone Number: 505-998-7200
        • Principal Investigator:
          • Kisria Rechul
    • New York
      • Buffalo, New York, United States, 14127
        • Recruiting
        • Rochester Clinical Research - Buffalo
        • Principal Investigator:
          • Rajiv Jain
    • Ohio
      • Cincinnati, Ohio, United States, 45212
        • Recruiting
        • CTI Clinical Research Center
        • Principal Investigator:
          • James Maynard
        • Contact:
          • Phone Number: 513-721-3868
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • Recruiting
        • Bogan Sleep Consultants
        • Contact:
          • Phone Number: 803-251-3093
        • Principal Investigator:
          • Laura Herpel
    • Texas
      • Austin, Texas, United States, 78731
        • Recruiting
        • FutureSearch Trials of Neurology
        • Contact:
          • Phone Number: 512-380-9925
        • Principal Investigator:
          • Gregory Tempest
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Sleep Therapy Research Center
        • Principal Investigator:
          • Nagwa Lamaie
      • Shavano Park, Texas, United States, 78231
        • Recruiting
        • Consano Clinical Research, LLC
        • Contact:
          • Phone Number: 210-545-4900
        • Principal Investigator:
          • Michelle Welch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Eloralintide (YSA1)
Participants will receive eloralintide subcutaneously (SC)
Drug: Eloralintide
Administered SC
Other Names:
  • LY3841136
Placebo Comparator: Placebo (YSA1)
Participants will receive placebo SC
Drug: Placebo
Administered SC
Experimental: Eloralintide (YSA2)
Participants will receive eloralintide SC
Drug: Eloralintide
Administered SC
Other Names:
  • LY3841136
Placebo Comparator: Placebo (YSA2)
Participants will receive placebo SC
Drug: Placebo
Administered SC

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Waist Circumference
Time Frame: Baseline, Week 64
Baseline, Week 64
Change from Baseline in Body Mass Index (BMI)
Time Frame: Baseline, Week 64
Baseline, Week 64
Percent Change from Baseline in High Sensitivity C-Reactive Protein (hsCRP)
Time Frame: Baseline, Week 64
Baseline, Week 64
Percent Change from Baseline in Fasting Insulin
Time Frame: Baseline, Week 64
Baseline, Week 64
Pharmacokinetics (PK): Maximum Concentration at Steady State (Cmax,ss)
Time Frame: Baseline through Week 64
Baseline through Week 64
PK: Area Under the Concentration Versus Time Curve for One Dosing Interval at Steady State (AUC(0-ᴛ)ss)
Time Frame: Baseline through Week 64
Baseline through Week 64
Percent Change from Baseline in Triglycerides
Time Frame: Baseline, Week 64
Baseline, Week 64
Change from Baseline in Systolic Blood Pressure (SBP)
Time Frame: Baseline, Week 64
Baseline, Week 64
Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Sleep-Related Impairment 8a T-Score
Time Frame: Baseline, Week 64
Baseline, Week 64
Achievement of AHI <5 or AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤ 10
Time Frame: Baseline, Week 64
Baseline, Week 64
Percent Change from Baseline in Sleep Apnea Specific Hypoxic Burden (SASHB)
Time Frame: Baseline, Week 64
Baseline, Week 64
Number of Participants who Achieve ≥50% decrease in AHI
Time Frame: Baseline, Week 64
Baseline, Week 64
Change from Baseline in Fasting Glucose
Time Frame: Baseline, Week 64
Baseline, Week 64
Change from Baseline in ESS Score
Time Frame: Baseline, Week 64
Baseline, Week 64
Change from Baseline in Short Form-36 (SF-36 v2) Scores
Time Frame: Baseline, Week 64
Baseline, Week 64
Change from Baseline in EQ-5D-5L Scores
Time Frame: Baseline, Week 64
Baseline, Week 64
Change in Medication Use
Time Frame: Baseline, Week 64
Baseline, Week 64
Achievement of Improved Categorical Shift in Patient Global Impression of Severity-Obstructive Sleep Apnea (PGIS-OSA)
Time Frame: Baseline, Week 64
Baseline, Week 64

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

January 23, 2026

First Submitted That Met QC Criteria

January 23, 2026

First Posted (Actual)

January 27, 2026

Study Record Updates

Last Update Posted (Actual)

August 24, 2026

Last Update Submitted That Met QC Criteria

August 21, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27764
  • 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • J3R-MC-YDAO (Other Identifier: Eli Lilly and Company)
  • J3R-MC-YSA1 (Other Identifier: Eli Lilly and Company)
  • J3R-MC-YSA2 (Other Identifier: Eli Lilly and Company)
  • 2025-523769-11-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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