Actively Recruiting
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
Led by Eli Lilly and Company · Updated on 2026-06-04
800
Participants Needed
129
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of eloralintide in adults with moderate-to-severe obstructive sleep apnea who are also overweight or obese. This study uses a master protocol called YDAO, which includes two separate studies: YSA1 for participants who cannot or choose not to use Positive Airway Pressure (PAP) therapy, and YSA2 for those who have been on PAP therapy for at least three months and plan to continue it during the study. The study is sponsored by Eli Lilly and Company and aims to assess changes in body weight and sleep apnea severity among other health measures. Participants will be randomly assigned to receive either eloralintide or a placebo, both administered by subcutaneous injection once weekly. The study includes two groups based on PAP therapy use, with each group receiving either the active drug or placebo. The treatment period lasts approximately 64 weeks, followed by assessments. The study is designed as a double-blind, placebo-controlled phase 3 trial to compare the effects of eloralintide on various outcomes. During the study, participants will undergo regular evaluations including body weight measurements, sleep studies to assess apnea-hypopnea index (AHI), blood pressure checks, blood tests for metabolic markers, and patient-reported outcome questionnaires related to sleep and quality of life. These assessments occur at baseline and week 64. The total participation time is about 76 weeks, during which safety and drug levels in the body will also be monitored. The goal is to understand how eloralintide affects weight, sleep apnea severity, and related health factors.
CONDITIONS
Brief Title
A Study of Eloralintide (LY3841136) in Participants With Obstructive Sleep Apnea and Obesity or Overweight
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Confirmed history of moderate-to-severe obstructive sleep apnea
- Apnea-Hypopnea Index (AHI) of 15 or higher on study polysomnography at screening
- Body Mass Index (BMI) of 27 kg/m2 or higher at screening
- Stable body weight with less than 5% change for 90 days prior to screening
- History of at least one unsuccessful dietary effort to reduce body weight
- For YSA1 participants: unable or unwilling to use PAP therapy
- For YSA2 participants: on PAP therapy for at least 3 consecutive months prior to screening and planning to continue during the study
You will not qualify if you...
- Prior or planned surgical treatment for obesity (liposuction, cryolipolysis, or abdominoplasty allowed if done more than 1 year before screening)
- Prior or planned endoscopic procedure or device-based therapy for obesity (device removal must be more than 6 months before screening)
- Previous or planned surgery for sleep apnea or major ear, nose, or throat surgery that may affect breathing at screening
- Diagnosis of type 1 diabetes, type 2 diabetes, or any other diabetes
- Within 90 days before screening, any of the following: acute myocardial infarction, stroke, coronary artery revascularization, unstable angina, or hospitalization due to congestive heart failure
- History or diagnosis of New York Heart Association Functional Class IV congestive heart failure
- Use of medications or alternative remedies for weight loss within 90 days before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 64 weeks
Participants receive weekly subcutaneous injections of eloralintide or placebo while their health and response to treatment are monitored.
Weekly visits for treatment and assessments
Trial Site Locations
Total: 129 locations
1
Cullman Clinical Trials
Cullman, Alabama, United States, 35055
Actively Recruiting
2
Ark Clinical Research
Long Beach, California, United States, 90815
Actively Recruiting
3
Collaborative Neuroscience Research, LLC
Los Alamitos, California, United States, 90720
Actively Recruiting
4
Artemis Institute for Clinical Research
Riverside, California, United States, 92503
Actively Recruiting
5
Care Access - Aurora
Aurora, Colorado, United States, 80012
Actively Recruiting
6
Flourish Research - Miami, LLC
Miami, Florida, United States, 33135
Actively Recruiting
7
PharmaDev Clinical Research Institute, LLC
Miami, Florida, United States, 33176
Actively Recruiting
8
Emerald Coast Neurology - Airport Boulevard
Pensacola, Florida, United States, 32504
Actively Recruiting
9
Teak Research Consults
Lawrenceville, Georgia, United States, 30043
Actively Recruiting
10
EBGS Clinical Research Center
Snellville, Georgia, United States, 30078
Actively Recruiting
11
Care Access - Shreveport 2
Shreveport, Louisiana, United States, 71105
Actively Recruiting
12
Flourish Research - Bowie
Bowie, Maryland, United States, 20715
Actively Recruiting
13
Revive Research Institute, Inc.
Southfield, Michigan, United States, 48075
Actively Recruiting
14
Headlands Research-Twin Cities
Maplewood, Minnesota, United States, 55109
Actively Recruiting
15
Clayton Sleep Institute - St. Louis - Tesson Ferry Road
St Louis, Missouri, United States, 63123
Actively Recruiting
16
Palm Research Center Tenaya
Las Vegas, Nevada, United States, 89128
Actively Recruiting
17
The Sleep Spot - Maimonides
Albuquerque, New Mexico, United States, 87107
Actively Recruiting
18
Rochester Clinical Research - Buffalo
Buffalo, New York, United States, 14127
Actively Recruiting
19
CTI Clinical Research Center
Cincinnati, Ohio, United States, 45212
Actively Recruiting
20
Bogan Sleep Consultants
Columbia, South Carolina, United States, 29201
Actively Recruiting
21
FutureSearch Trials of Neurology
Austin, Texas, United States, 78731
Actively Recruiting
22
Sleep Therapy Research Center
San Antonio, Texas, United States, 78229
Actively Recruiting
23
Consano Clinical Research, LLC
Shavano Park, Texas, United States, 78231
Actively Recruiting
24
Cicemo Srl
Buenos Aires, Argentina, 1424
Not Yet Recruiting
25
Stat Research S.A.
Buenos Aires, Argentina, C1023AAB
Not Yet Recruiting
26
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires, Argentina, C1056ABI
Not Yet Recruiting
27
Centro Médico Viamonte
Buenos Aires, Argentina, C1120AAC
Not Yet Recruiting
28
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires, Argentina, C1425AGC
Not Yet Recruiting
29
Fundación Respirar
Buenos Aires, Argentina, C1426ABP
Not Yet Recruiting
30
Centro de Investigaciones Clínicas Baigorria
Granadero Baigorria, Argentina, 2152
Not Yet Recruiting
31
Instituto Médico Río Cuarto
Río Cuarto, Argentina, X5800AEV
Not Yet Recruiting
32
INECO Neurociencias Oroño
Rosario, Argentina, 2000
Not Yet Recruiting
33
Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica
Rosario, Argentina, 2000
Not Yet Recruiting
34
CIMER Centro Integral de Medicina Respiratoria
San Miguel de Tucumán, Argentina, 4000
Not Yet Recruiting
35
Centro de Salud e Investigaciones Médicas
Santa Rosa, Argentina, L6300
Not Yet Recruiting
36
Nightingale Research
Adelaide, Australia, 5000
Not Yet Recruiting
37
Flinders University
Bedford Park, Australia, 5042
Not Yet Recruiting
38
Box Hill Hospital
Box Hill, Australia, 3128
Not Yet Recruiting
39
Core Research Group
Brisbane, Australia, 4064
Not Yet Recruiting
40
Austin Health - Repatriation Hospital
Heidelberg West, Australia, 3081
Not Yet Recruiting
41
CDH Research Institute Pty Ltd
Maroochydore, Australia, 4558
Not Yet Recruiting
42
Gold Coast University Hospital
Southport, Australia, 4215
Not Yet Recruiting
43
TrialsWest - Spearwood
Spearwood, Australia, 6163
Not Yet Recruiting
44
Instituto de Pesquisa clinica de Campinas
Campinas, Brazil, 13060-080
Not Yet Recruiting
45
Centro de Pesquisa Clínica de Marília - CPCLIM
Marília, Brazil, 17504-072
Not Yet Recruiting
46
Núcleo de Pesquisa Clínica do Rio Grande do Sul
Porto Alegre, Brazil, 90430-001
Not Yet Recruiting
47
CEMER - Centro Médico do Recife
Recife, Brazil, 51110-160
Not Yet Recruiting
48
Ruschel Medicina e Pesquisa Clínica
Rio de Janeiro, Brazil, 22270-060
Not Yet Recruiting
49
Prognosis Pesquisa Clínica
Santo André, Brazil, 09040-010
Not Yet Recruiting
50
CPHosp Medicina, Ensino e Pesquisa (CPQuali)
São Paulo, Brazil, 01228-000
Not Yet Recruiting
51
BR Trials - Ensaios Clinicos e Consultoria
São Paulo, Brazil, 01236030
Not Yet Recruiting
52
CEPIC - Centro Paulista de Investigação Clínica
São Paulo, Brazil, 04266-010
Not Yet Recruiting
53
Incor - Instituto do Coracao
São Paulo, Brazil, 05403-900
Not Yet Recruiting
54
MyCliniResearch, Inc.
Calgary, Canada, T2Z 3R6
Actively Recruiting
55
Alpha Recherche Clinique - Lévis
Lévis, Canada, G6V 0C9
Actively Recruiting
56
Alpha Recherche Clinique
Québec, Canada, G2J 0C4
Actively Recruiting
57
C.I.C. Joliette
Saint-Charles-Borromée, Canada, J6E 2B4
Not Yet Recruiting
58
C.I.C. Saint-Laurent
Saint-Laurent, Canada, H4R 3C8
Not Yet Recruiting
59
Maple Leaf Research
Toronto, Canada, M5G 1K2
Actively Recruiting
60
C.I.C. Mauricie inc.
Trois-Rivières, Canada, G8T 7A1
Actively Recruiting
61
China-Japan Friendship Hospital
Beijing, China, 100029
Not Yet Recruiting
62
The First Hospital of Jilin University
Changchun, China, 130021
Not Yet Recruiting
63
The Second Hospital of Jilin University
Changchun, China, 130041
Not Yet Recruiting
64
The Third Xiangya Hospital of Central South University
Changsha, China, 410013
Not Yet Recruiting
65
Sichuan Provincial People's Hospital
Chengdu, China, 610072
Not Yet Recruiting
66
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China, 400016
Not Yet Recruiting
67
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China, 510360
Not Yet Recruiting
68
The Second People's Hospital of Hefei
Hefei, China, 230011
Not Yet Recruiting
69
The First People's Hospital of Yunnan Province
Kunming, China, 650034
Not Yet Recruiting
70
Gansu Provincial Hospital
Lanzhou, China, 730000
Not Yet Recruiting
71
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang Shi, China, 471003
Not Yet Recruiting
72
The Second Affiliated Hospital of Nanchang University
Nanchang, China, 330006
Not Yet Recruiting
73
Jiangxi Provincial People's Hospital
Nanchang, China, 330038
Not Yet Recruiting
74
Nanjing First Hospital
Nanjing, China, 210006
Not Yet Recruiting
75
The Second Affiliated Hospital of Guangxi Medical University
Nanning, China, 053007
Not Yet Recruiting
76
Ningbo First Hospital
Ningbo, China, 315010
Not Yet Recruiting
77
Shanghai Sixth People's Hospital
Shanghai, China, 200030
Not Yet Recruiting
78
Shanghai East Hospital
Shanghai, China, 200120
Not Yet Recruiting
79
ShenZhen People's Hospital
Shenzhen, China, 518020
Not Yet Recruiting
80
Shenzhen Hospital of Southern Medical University
Shenzhen, China, 518110
Not Yet Recruiting
81
The Second Affiliated Hospital of Soochow University
Suzhou, China, 215004
Not Yet Recruiting
82
Wuxi People's Hospital
Wuxi, China, 214023
Not Yet Recruiting
83
Xianyang Hospital of Yan'an University
Xianyang, China, 712000
Not Yet Recruiting
84
CIMS Studienzentrum Bamberg
Bamberg, Germany, 96049
Not Yet Recruiting
85
Advanced Sleep Research
Berlin, Germany, 10117
Not Yet Recruiting
86
InnoDiab Forschung Gmbh
Essen, Germany, 45136
Not Yet Recruiting
87
Siteworks GmbH - Hannover
Hanover, Germany, 30449
Not Yet Recruiting
88
Siteworks - Karlsruhe
Karlsruhe, Germany, 76137
Not Yet Recruiting
89
Universitätsklinikum Marburg
Marburg, Germany, 35033
Not Yet Recruiting
90
RED-Institut GmbH
Oldenburg, Germany, 23758
Not Yet Recruiting
91
Somni bene
Schwerin, Germany, 19053
Not Yet Recruiting
92
SDS Tuberculosis Research Center & Rajiv Gandhi Institute of Chest Diseases
Bengaluru, India, 560029
Not Yet Recruiting
93
St. Johns Medical College Hospital
Bengaluru, India, 560034
Not Yet Recruiting
94
Utkal Institute of Medical Sciences and Hospital
Bhubaneswar, India, 751021
Not Yet Recruiting
95
Endolife Speciality Hospitals
Guntur, India, 522001
Not Yet Recruiting
96
KRIMS Hospital
Nagpur, India, 440010
Not Yet Recruiting
97
All India Institute of Medical Sciences
New Delhi, India, 110029
Not Yet Recruiting
98
Sir Ganga Ram Hospital
New Delhi, India, 110060
Not Yet Recruiting
99
Deenanath Mangeshkar Hospital & Research Centre
Pune, India, 411004
Not Yet Recruiting
100
All India Institute of Medical Sciences
Raipur, India, 492099
Not Yet Recruiting
101
All India Institute of Medical Sciences - Rishikesh
Rishikesh, India, 249203
Not Yet Recruiting
102
Bhakti Vedanta Hospital and Research Institute
Thane, India, 401107
Not Yet Recruiting
103
Rhythm Heart Institute - A Unit of SLPL
Vadodara, India, 390022
Not Yet Recruiting
104
Juntendo University Hospital
Bunkyō City, Japan, 113-8431
Actively Recruiting
105
Fukuoka University Hospital
Fukuoka, Japan, 814-0180
Actively Recruiting
106
Social Medical Corporation Sokujinkai Sleep and Mental Health Clinic - Kitahiroshima
Kitahiroshima, Japan, 061-1121
Actively Recruiting
107
Kirigaokatsuda Hospital
Kitakyushu, Japan, 802-0052
Actively Recruiting
108
Toranomon Hospital
Minatoku, Japan, 105-8470
Actively Recruiting
109
Osaka Kaisei Hospital
Osaka, Japan, 532-0003
Actively Recruiting
110
KKR Sapporo Medical Center
Sapporo, Japan, 062-0931
Not Yet Recruiting
111
Yoyogi Sleep Disorder Center
Shibuya-ku, Japan, 151-0053
Actively Recruiting
112
Nakamura Clinic
Urasoe, Japan, 901-2132
Actively Recruiting
113
RESM Respiratory and Sleep Medical Care Clinic
Yokohama, Japan, 222-0033
Actively Recruiting
114
Korea University Ansan Hospital
Ansan-si, South Korea, 15355
Not Yet Recruiting
115
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722
Not Yet Recruiting
116
Asan Medical Center
Seoul, South Korea, 05505
Not Yet Recruiting
117
Korea University Guro Hospital
Seoul, South Korea, 08308
Not Yet Recruiting
118
Hospital Universitario de Guadalajara
Guadalajara, Spain, 19002
Actively Recruiting
119
Hospital Universitari de Santa Maria
Lleida, Spain, 25198
Actively Recruiting
120
Hospital San Pedro
Logroño, Spain, 26006
Not Yet Recruiting
121
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Actively Recruiting
122
Instituto de Investigaciones del Sueño
Madrid, Spain, 28036
Actively Recruiting
123
Hospital Universitario La Paz
Madrid, Spain, 28046
Not Yet Recruiting
124
Hospital Universitario Virgen de la Victoria
Málaga, Spain, 29010
Not Yet Recruiting
125
Hospital Quiron Infanta Luisa
Seville, Spain, 41010
Not Yet Recruiting
126
Hospital Universitario Virgen Del Rocio
Seville, Spain, 41013
Actively Recruiting
127
China Medical University Hospital
Taichung, Taiwan, 40447
Not Yet Recruiting
128
National Cheng-Kung Uni. Hosp.
Tainan, Taiwan, 704
Not Yet Recruiting
129
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, Taiwan, 333
Not Yet Recruiting
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
P
Physicians interested in becoming principal investigators please contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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