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
Status: Recruiting
Location: See all (115) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Alabama
Cullman Clinical Trials
RECRUITING
Cullman
California
Ark Clinical Research
RECRUITING
Long Beach
Collaborative Neuroscience Research, LLC
RECRUITING
Los Alamitos
Artemis Institute for Clinical Research
RECRUITING
Riverside
Colorado
Care Access - Aurora
RECRUITING
Aurora
Florida
Flourish Research - Miami, LLC
RECRUITING
Miami
PharmaDev Clinical Research Institute, LLC
RECRUITING
Miami
Emerald Coast Neurology - Airport Boulevard
RECRUITING
Pensacola
Georgia
Teak Research Consults
RECRUITING
Lawrenceville
EBGS Clinical Research Center
RECRUITING
Snellville
Louisiana
Care Access - Shreveport 2
RECRUITING
Shreveport
Maryland
Flourish Research - Bowie
RECRUITING
Bowie
Michigan
Revive Research Institute, Inc.
RECRUITING
Southfield
Minnesota
Headlands Research-Twin Cities
RECRUITING
Maplewood
Missouri
Clayton Sleep Institute - St. Louis - Tesson Ferry Road
RECRUITING
St Louis
New Mexico
The Sleep Spot - Maimonides
RECRUITING
Albuquerque
Nevada
Palm Research Center Tenaya
RECRUITING
Las Vegas
New York
Rochester Clinical Research - Buffalo
RECRUITING
Buffalo
Ohio
CTI Clinical Research Center
RECRUITING
Cincinnati
South Carolina
Bogan Sleep Consultants
RECRUITING
Columbia
Texas
FutureSearch Trials of Neurology
RECRUITING
Austin
Sleep Therapy Research Center
RECRUITING
San Antonio
Consano Clinical Research, LLC
RECRUITING
Shavano Park
Other Locations
Australia
Nightingale Research
RECRUITING
Adelaide
Flinders University
RECRUITING
Bedford Park
Box Hill Hospital
RECRUITING
Box Hill
Core Research Group
RECRUITING
Brisbane
Austin Health - Repatriation Hospital
RECRUITING
Heidelberg West
CDH Research Institute Pty Ltd
RECRUITING
Maroochydore
Gold Coast University Hospital
RECRUITING
Southport
TrialsWest - Spearwood
RECRUITING
Spearwood
Brazil
Instituto de Pesquisa clinica de Campinas
SUSPENDED
Campinas
Centro de Pesquisa Clínica de Marília - CPCLIM
SUSPENDED
Marília
Núcleo de Pesquisa Clínica do Rio Grande do Sul
SUSPENDED
Porto Alegre
CEMER - Centro Médico do Recife
SUSPENDED
Recife
Ruschel Medicina e Pesquisa Clínica
SUSPENDED
Rio De Janeiro
Prognosis Pesquisa Clínica
SUSPENDED
Santo André
BR Trials - Ensaios Clinicos e Consultoria
SUSPENDED
São Paulo
CEPIC - Centro Paulista de Investigação Clínica
SUSPENDED
São Paulo
CPHosp Medicina, Ensino e Pesquisa (CPQuali)
SUSPENDED
São Paulo
Incor - Instituto do Coracao
SUSPENDED
São Paulo
Canada
MyCliniResearch, Inc.
RECRUITING
Calgary
Alpha Recherche Clinique - Lévis
RECRUITING
Lévis
Alpha Recherche Clinique
RECRUITING
Québec
C.I.C. Saint-Laurent
RECRUITING
Saint-laurent
Maple Leaf Research
RECRUITING
Toronto
C.I.C. Mauricie inc.
RECRUITING
Trois-rivières
China
China-Japan Friendship Hospital
NOT_YET_RECRUITING
Beijing
The First Hospital of Jilin University
NOT_YET_RECRUITING
Changchun
The Second Hospital of Jilin University
NOT_YET_RECRUITING
Changchun
The Third Xiangya Hospital of Central South University
NOT_YET_RECRUITING
Changsha
Sichuan Provincial People's Hospital
NOT_YET_RECRUITING
Chengdu
The First Affiliated Hospital of Chongqing Medical University
NOT_YET_RECRUITING
Chongqing
The First Affiliated Hospital of Guangzhou Medical University
NOT_YET_RECRUITING
Guangzhou
The Second People's Hospital of Hefei
NOT_YET_RECRUITING
Hefei
The First People's Hospital of Yunnan Province
NOT_YET_RECRUITING
Kunming
Gansu Provincial Hospital
NOT_YET_RECRUITING
Lanzhou
The First Affiliated Hospital of Henan University of Science &Technology
NOT_YET_RECRUITING
Luoyang Shi
Jiangxi Provincial People's Hospital
NOT_YET_RECRUITING
Nanchang
Nanjing First Hospital
NOT_YET_RECRUITING
Nanjing
The Second Affiliated Hospital of Guangxi Medical University
NOT_YET_RECRUITING
Nanning
Ningbo First Hospital
NOT_YET_RECRUITING
Ningbo
Shanghai East Hospital
NOT_YET_RECRUITING
Shanghai
Shanghai Sixth People's Hospital
NOT_YET_RECRUITING
Shanghai
Shenzhen Hospital of Southern Medical University
NOT_YET_RECRUITING
Shenzhen
ShenZhen People's Hospital
NOT_YET_RECRUITING
Shenzhen
The Second Affiliated Hospital of Soochow University
NOT_YET_RECRUITING
Suzhou
Wuxi People's Hospital
NOT_YET_RECRUITING
Wuxi
Xianyang Hospital of Yan'an University
NOT_YET_RECRUITING
Xianyang
Germany
CIMS Studienzentrum Bamberg
RECRUITING
Bamberg
Advanced Sleep Research
RECRUITING
Berlin
InnoDiab Forschung Gmbh
RECRUITING
Essen
Siteworks GmbH - Hannover
RECRUITING
Hanover
Siteworks - Karlsruhe
RECRUITING
Karlsruhe
Universitätsklinikum Marburg
RECRUITING
Marburg
RED-Institut GmbH
RECRUITING
Oldenburg
Somni bene
RECRUITING
Schwerin
India
SDS Tuberculosis Research Center & Rajiv Gandhi Institute of Chest Diseases
NOT_YET_RECRUITING
Bengaluru
St. Johns Medical College Hospital
NOT_YET_RECRUITING
Bengaluru
Utkal Institute of Medical Sciences and Hospital
RECRUITING
Bhubaneswar
Endolife Speciality Hospitals
RECRUITING
Guntur
KRIMS Hospital
RECRUITING
Nagpur
All India Institute of Medical Sciences
RECRUITING
New Delhi
Sir Ganga Ram Hospital
NOT_YET_RECRUITING
New Delhi
Deenanath Mangeshkar Hospital & Research Centre
RECRUITING
Pune
All India Institute of Medical Sciences
RECRUITING
Raipur
All India Institute of Medical Sciences - Rishikesh
RECRUITING
Rishikesh
Bhakti Vedanta Hospital and Research Institute
RECRUITING
Thane
Rhythm Heart Institute - A Unit of SLPL
NOT_YET_RECRUITING
Vadodara
Japan
Juntendo University Hospital
RECRUITING
Bunkyō City
Fukuoka University Hospital
RECRUITING
Fukuoka
Social Medical Corporation Sokujinkai Sleep and Mental Health Clinic - Kitahiroshima
RECRUITING
Kitahiroshima
Kirigaokatsuda Hospital
RECRUITING
Kitakyushu
Toranomon Hospital
RECRUITING
Minatoku
Osaka Kaisei Hospital
RECRUITING
Osaka
KKR Sapporo Medical Center
RECRUITING
Sapporo
Yoyogi Sleep Disorder Center
RECRUITING
Shibuya-ku
Nakamura Clinic
RECRUITING
Urasoe
RESM Respiratory and Sleep Medical Care Clinic
RECRUITING
Yokohama
Republic of Korea
Korea University Ansan Hospital
RECRUITING
Ansan-si
Asan Medical Center
RECRUITING
Seoul
Korea University Guro Hospital
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
Spain
Hospital Universitario de Guadalajara
RECRUITING
Guadalajara
Hospital Universitari de Santa Maria
RECRUITING
Lleida
Hospital San Pedro
RECRUITING
Logroño
Hospital Universitario La Paz
NOT_YET_RECRUITING
Madrid
Hospital Universitario Ramón y Cajal
RECRUITING
Madrid
Instituto de Investigaciones del Sueño
RECRUITING
Madrid
Hospital Universitario Virgen de la Victoria
RECRUITING
Málaga
Hospital Quiron Infanta Luisa
NOT_YET_RECRUITING
Seville
Hospital Universitario Virgen Del Rocio
RECRUITING
Seville
Taiwan
China Medical University Hospital
RECRUITING
Taichung
National Cheng-Kung Uni. Hosp.
RECRUITING
Tainan
Chang Gung Medical Foundation-Linkou Branch
RECRUITING
Taoyuan
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2026-02-10
Estimated Completion Date: 2028-04
Participants
Target number of participants: 800
Treatments
Experimental: Eloralintide (YSA1)
Participants will receive eloralintide subcutaneously (SC)
Placebo_comparator: Placebo (YSA1)
Participants will receive placebo SC
Experimental: Eloralintide (YSA2)
Participants will receive eloralintide SC
Placebo_comparator: Placebo (YSA2)
Participants will receive placebo SC
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company