- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07369011
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
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
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
- Name: Physicians interested in becoming principal investigators please contact
- Email: clinical_inquiry_hub@lilly.com
Study Locations
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Buenos Aires, Argentina, C1426ABP
- Not yet recruiting
- Fundación Respirar
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Principal Investigator:
- Pablo Doreski
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Contact:
- Phone Number: +549115 800 5058
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Buenos Aires, Argentina, C1056ABI
- Not yet recruiting
- Centro de Investigaciones Metabólicas (CINME)
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Contact:
- Phone Number: 08003450697
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Principal Investigator:
- Maria Grossman
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Buenos Aires, Argentina, C1120AAC
- Not yet recruiting
- Centro Médico Viamonte
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Principal Investigator:
- Diego Aizenberg
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Contact:
- Phone Number: 54 1149635650
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Buenos Aires, Argentina, C1023AAB
- Not yet recruiting
- Stat Research S.A.
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Principal Investigator:
- Lucas Gutnisky
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Contact:
- Phone Number: (54 11) 48166733
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Buenos Aires, Argentina, C1425AGC
- Not yet recruiting
- Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
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Contact:
- Phone Number: 01148019001
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Principal Investigator:
- Maria Garro
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Buenos Aires, Argentina, 1424
- Not yet recruiting
- Cicemo Srl
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Contact:
- Phone Number: 541160410129
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Principal Investigator:
- Alejandro de Dios
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Granadero Baigorria, Argentina, 2152
- Not yet recruiting
- Centro de Investigaciones Clínicas Baigorria
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Principal Investigator:
- Juan Dominguez
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Contact:
- Phone Number: 5493412106243
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Rosario, Argentina, 2000
- Not yet recruiting
- INECO Neurociencias Orono
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Principal Investigator:
- Dana Miralles
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Contact:
- Phone Number: 543415004351
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Rosario, Argentina, 2000
- Not yet recruiting
- Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica
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Contact:
- Phone Number: 54 3416912080
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Principal Investigator:
- FERNANDO MASSOLA
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Río Cuarto, Argentina, X5800AEV
- Not yet recruiting
- Instituto Medico Rio Cuarto
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Contact:
- Phone Number: 541131077237
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Principal Investigator:
- Carolina Cappelletti
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San Miguel de Tucumán, Argentina, 4000
- Not yet recruiting
- CIMER Centro Integral de Medicina Respiratoria
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Principal Investigator:
- Hector Altieri
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Contact:
- Phone Number: 54-9-381-2060742
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Santa Rosa, Argentina, L6300
- Not yet recruiting
- Centro de Salud e Investigaciones Médicas
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Contact:
- Phone Number: 542954244444
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Principal Investigator:
- Marcos Mayer
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Adelaide, Australia, 5000
- Not yet recruiting
- Nightingale Research
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Principal Investigator:
- Andrew Hamilton
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Bedford Park, Australia, 5042
- Not yet recruiting
- Flinders University
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Principal Investigator:
- Danny Eckert
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Contact:
- Phone Number: 61 8 74219780
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Box Hill, Australia, 3128
- Not yet recruiting
- Box Hill Hospital
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Principal Investigator:
- Ming Li Yee
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Brisbane, Australia, 4064
- Not yet recruiting
- Core Research Group
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Contact:
- Phone Number: 61738765688
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Principal Investigator:
- David Colquhoun
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Heidelberg West, Australia, 3081
- Not yet recruiting
- Austin Health - Repatriation Hospital
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Contact:
- Phone Number: 0394962160
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Principal Investigator:
- Elif Ekinci
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Maroochydore, Australia, 4558
- Not yet recruiting
- CDH Research Institute Pty Ltd
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Principal Investigator:
- Hansjoerg Seltenreich
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Contact:
- Phone Number: 07 5408 0900
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Southport, Australia, 4215
- Not yet recruiting
- Gold Coast University Hospital
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Contact:
- Phone Number: 0432143849
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Principal Investigator:
- George Tay
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Spearwood, Australia, 6163
- Not yet recruiting
- TrialsWest - Spearwood
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Contact:
- Phone Number: 61893121931
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Principal Investigator:
- Peter Bremner
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Campinas, Brazil, 13060-080
- Not yet recruiting
- Instituto de Pesquisa Clinica de Campinas
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Principal Investigator:
- Flavia Guimarães
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Marília, Brazil, 17504-072
- Not yet recruiting
- Centro de Pesquisa Clínica de Marília - CPCLIM
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Principal Investigator:
- José Sgarbi
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Contact:
- Phone Number: 55 14 21051477
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Porto Alegre, Brazil, 90430-001
- Not yet recruiting
- Núcleo de Pesquisa Clínica do Rio Grande do Sul
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Contact:
- Phone Number: 555137796400
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Principal Investigator:
- Luis Henrique Canani
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Recife, Brazil, 51110-160
- Not yet recruiting
- CEMER - Centro Médico do Recife
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Principal Investigator:
- RODRIGO PEDROSA
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Rio de Janeiro, Brazil, 22270-060
- Not yet recruiting
- Ruschel Medicina e Pesquisa Clínica
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Contact:
- Phone Number: 552135979708
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Principal Investigator:
- Luiza Siffert
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Santo André, Brazil, 09040-010
- Not yet recruiting
- Prognosis Pesquisa Clínica
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Contact:
- Phone Number: +5511932661993
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Principal Investigator:
- Mayara da Costa
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São Paulo, Brazil, 04266-010
- Not yet recruiting
- CEPIC - Centro Paulista de Investigação Clínica
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Contact:
- Phone Number: 551122713450
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Principal Investigator:
- Breno Balabem Alves
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São Paulo, Brazil, 05403-900
- Not yet recruiting
- Incor - Instituto do Coracao
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Contact:
- Phone Number: +5511988027887
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Principal Investigator:
- Luciano Drager
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São Paulo, Brazil, 01228-000
- Not yet recruiting
- CPHosp Medicina, Ensino e Pesquisa (CPQuali)
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Principal Investigator:
- Gustavo Augusto
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Contact:
- Phone Number: 55 11 2776-6801
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São Paulo, Brazil, 01236030
- Not yet recruiting
- BR Trials - Ensaios Clinicos e Consultoria
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Contact:
- Phone Number: 551130630063
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Principal Investigator:
- Bruno Halpern
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Calgary, Canada, T2Z 3R6
- Recruiting
- MyCliniResearch, Inc.
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Contact:
- Phone Number: 5873320600
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Principal Investigator:
- Wilfred Alonso
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Lévis, Canada, G6V 0C9
- Recruiting
- Alpha Recherche Clinique - Lévis
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Contact:
- Phone Number: 418-380-1112
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Principal Investigator:
- Dominique Deschênes
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Québec, Canada, G2J 0C4
- Recruiting
- Alpha Recherche Clinique
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Principal Investigator:
- Nancy Labrecque
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Saint-Charles-Borromée, Canada, J6E 2B4
- Not yet recruiting
- C.I.C. Joliette
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Principal Investigator:
- Eve Melancon
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Saint-Laurent, Canada, H4R 3C8
- Not yet recruiting
- C.I.C. Saint-Laurent
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Contact:
- Phone Number: 8193731128
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Principal Investigator:
- Emilie Millaire
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Toronto, Canada, M5G 1K2
- Recruiting
- Maple Leaf Research
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Principal Investigator:
- Graham Smith
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Contact:
- Phone Number: 4164657936
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Trois-Rivières, Canada, G8T 7A1
- Recruiting
- C.I.C. Mauricie inc.
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Principal Investigator:
- Pierre-Alexandre Menard
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Beijing, China, 100029
- Not yet recruiting
- China-Japan Friendship Hospital
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Principal Investigator:
- Xiaolei Zhang
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Changchun, China, 130021
- Not yet recruiting
- The First Hospital of Jilin University
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Contact:
- Phone Number: 15843081103
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Principal Investigator:
- Guixia Wang
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Changchun, China, 130041
- Not yet recruiting
- The Second Hospital of Jilin University
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Principal Investigator:
- Hanqing Cai
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Changsha, China, 410013
- Not yet recruiting
- The Third Xiangya Hospital of Central South University
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Principal Investigator:
- Ping Jin
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Chengdu, China, 610072
- Not yet recruiting
- Sichuan Provincial People's Hospital
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Principal Investigator:
- Yan Yang
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Chongqing, China, 400016
- Not yet recruiting
- The First Affiliated Hospital of Chongqing Medical University
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Principal Investigator:
- Tao Chen
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Guangzhou, China, 510360
- Not yet recruiting
- The First Affiliated Hospital of Guangzhou Medical University
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Principal Investigator:
- Nuofu Zhang
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Hefei, China, 230011
- Not yet recruiting
- The Second People's Hospital of Hefei
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Principal Investigator:
- Jun Ye
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Contact:
- Phone Number: 86-13956099720
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Kunming, China, 650034
- Not yet recruiting
- The First People's Hospital of Yunnan Province
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Contact:
- Phone Number: 18908710522
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Principal Investigator:
- Yikun Zhou
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Lanzhou, China, 730000
- Not yet recruiting
- Gansu Provincial Hospital
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Principal Investigator:
- Peilin Hui
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Luoyang Shi, China, 471003
- Not yet recruiting
- The First Affiliated Hospital of Henan University of Science &Technology
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Principal Investigator:
- Hongwei Jiang
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Contact:
- Phone Number: 13653880139
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Nanchang, China, 330006
- Not yet recruiting
- The Second Affiliated Hospital of Nanchang University
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Principal Investigator:
- Xiaoqun Ye
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Nanchang, China, 330038
- Not yet recruiting
- Jiangxi Provincial People's Hospital
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Principal Investigator:
- Zongyou Cheng
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Contact:
- Phone Number: 13767035719
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Nanjing, China, 210006
- Not yet recruiting
- Nanjing First Hospital
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Principal Investigator:
- Qian Li
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Nanning, China, 053007
- Not yet recruiting
- The Second Affiliated Hospital of Guangxi Medical University
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Principal Investigator:
- xiaoyu Tan
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Ningbo, China, 315010
- Not yet recruiting
- Ningbo First Hospital
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Contact:
- Phone Number: 13757426626
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Principal Investigator:
- Li Li
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Shanghai, China, 200120
- Not yet recruiting
- Shanghai East Hospital
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Principal Investigator:
- You Yin
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Shanghai, China, 200030
- Not yet recruiting
- Shanghai Sixth People's Hospital
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Principal Investigator:
- Shankai Yin
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Shenzhen, China, 518020
- Not yet recruiting
- ShenZhen People's Hospital
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Contact:
- Phone Number: +8613510099301
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Principal Investigator:
- Hanrong Cheng
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Shenzhen, China, 518110
- Not yet recruiting
- Shenzhen Hospital of Southern Medical University
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Principal Investigator:
- Lingling Xu
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Suzhou, China, 215004
- Not yet recruiting
- The Second Affiliated Hospital of Soochow University
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Principal Investigator:
- Rui Chen
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Wuxi, China, 214023
- Not yet recruiting
- Wuxi People's Hospital
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Principal Investigator:
- Xiaowei ZHU
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Contact:
- Phone Number: 86-13812050092
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Xianyang, China, 712000
- Not yet recruiting
- Xianyang Hospital of Yan'an University
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Principal Investigator:
- Wei Zhang
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Bamberg, Germany, 96049
- Not yet recruiting
- CIMS Studienzentrum Bamberg
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Principal Investigator:
- Johannes Haas
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Contact:
- Phone Number: 0049951 51099580
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Berlin, Germany, 10117
- Not yet recruiting
- Advanced Sleep Research
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Contact:
- Phone Number: 493028886770
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Principal Investigator:
- Katharina Lederer
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Essen, Germany, 45136
- Not yet recruiting
- InnoDiab Forschung GmbH
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Principal Investigator:
- Thomas Schürholz
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Contact:
- Phone Number: 49 201 89942100
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Hanover, Germany, 30449
- Not yet recruiting
- Siteworks GmbH - Hannover
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Contact:
- Phone Number: +4951151524747
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Principal Investigator:
- Ulrike Lengler
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Karlsruhe, Germany, 76137
- Not yet recruiting
- Siteworks - Karlsruhe
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Contact:
- Phone Number: 0049 721 619004 90
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Principal Investigator:
- Julia Chevts
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Marburg, Germany, 35033
- Not yet recruiting
- Universitätsklinikum Marburg
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Contact:
- Phone Number: 004964215862777
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Principal Investigator:
- Christian Viniol
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Oldenburg, Germany, 23758
- Not yet recruiting
- RED-Institut GmbH
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Principal Investigator:
- Thomas Schaum
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Contact:
- Phone Number: 0049436150630128
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Schwerin, Germany, 19053
- Not yet recruiting
- Somni bene
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Contact:
- Phone Number: 0049 385207980
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Principal Investigator:
- Heike Benes
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Bengaluru, India, 560029
- Not yet recruiting
- SDS Tuberculosis Research Center & Rajiv Gandhi Institute of Chest Diseases
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Principal Investigator:
- Akshata S
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Contact:
- Phone Number: 9113030135
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Bengaluru, India, 560034
- Not yet recruiting
- St. Johns Medical College Hospital
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Principal Investigator:
- UMA MAHESWARI KRISHNASWAMY
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Contact:
- Phone Number: +91 9483702412
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Bhubaneswar, India, 751021
- Not yet recruiting
- Utkal Institute of Medical Sciences and Hospital
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Principal Investigator:
- Satyajeet Sahoo
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Guntur, India, 522001
- Not yet recruiting
- Endolife Speciality Hospitals
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Principal Investigator:
- GADDIPATI BABU
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Contact:
- Phone Number: 9849945577
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Nagpur, India, 440010
- Not yet recruiting
- KRIMS Hospital
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Principal Investigator:
- Ashok Arbat
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New Delhi, India, 110029
- Not yet recruiting
- All India Institute of Medical Sciences
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Principal Investigator:
- Saurabh Mittal
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New Delhi, India, 110060
- Not yet recruiting
- Sir Ganga Ram Hospital
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Contact:
- Phone Number: +919811051841
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Principal Investigator:
- Sanjay Manchanda
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Pune, India, 411004
- Not yet recruiting
- Deenanath Mangeshkar Hospital & Research Centre
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Principal Investigator:
- Balasaheb Pawar
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Raipur, India, 492099
- Not yet recruiting
- All India Institute of Medical Sciences
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Principal Investigator:
- Dibakar Sahu
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Rishikesh, India, 249203
- Not yet recruiting
- All India Institute of Medical Sciences - Rishikesh
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Contact:
- Phone Number: +91-8890293424
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Principal Investigator:
- Lokesh Saini
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Thane, India, 401107
- Not yet recruiting
- Bhakti Vedanta Hospital and Research Institute
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Principal Investigator:
- Ajay Godse
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Contact:
- Phone Number: 079 6900 2222
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Vadodara, India, 390022
- Not yet recruiting
- Rhythm Heart Institute - A Unit of SLPL
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Contact:
- Phone Number: 9925207953
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Principal Investigator:
- Tejas Kakkad
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Bunkyō City, Japan, 113-8431
- Recruiting
- Juntendo University Hospital
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Contact:
- Phone Number: 81120023812
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Principal Investigator:
- Takatoshi Kasai
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Fukuoka, Japan, 814-0180
- Recruiting
- Fukuoka University Hospital
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Contact:
- Phone Number: 81120023812
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Principal Investigator:
- Masaki Fujita
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Kitahiroshima, Japan, 061-1121
- Recruiting
- Social Medical Corporation Sokujinkai Sleep and Mental Health Clinic - Kitahiroshima
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Contact:
- Phone Number: 81120023812
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Principal Investigator:
- Jun Miura
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Kitakyushu, Japan, 802-0052
- Recruiting
- Kirigaokatsuda Hospital
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Contact:
- Phone Number: 81120023812
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Principal Investigator:
- Tetsuya Kawano
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Minatoku, Japan, 105-8470
- Recruiting
- Toranomon Hospital
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Contact:
- Phone Number: 81120023812
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Principal Investigator:
- Satoshi Kasagi
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Osaka, Japan, 532-0003
- Recruiting
- Osaka Kaisei Hospital
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Contact:
- Phone Number: 81120023812
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Principal Investigator:
- Saeko Osawa
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Sapporo, Japan, 062-0931
- Not yet recruiting
- KKR Sapporo Medical Center
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Contact:
- Phone Number: 81120023812
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Principal Investigator:
- Hiroshi Saito
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Shibuya-ku, Japan, 151-0053
- Recruiting
- Yoyogi Sleep Disorder Center
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Contact:
- Phone Number: 81120023812
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Principal Investigator:
- Hideaki Nakayama
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Urasoe, Japan, 901-2132
- Recruiting
- Nakamura Clinic
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Contact:
- Phone Number: 81120023812
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Principal Investigator:
- Kei Nakamura
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Yokohama, Japan, 222-0033
- Recruiting
- RESM Respiratory and Sleep Medical Care Clinic
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Contact:
- Phone Number: 81120023812
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Principal Investigator:
- Ryutaro Shirahama
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Ansan-si, South Korea, 15355
- Not yet recruiting
- Korea University Ansan Hospital
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Principal Investigator:
- Seung Hoon LEE
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Seoul, South Korea, 03722
- Not yet recruiting
- Severance Hospital, Yonsei University Health System
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Principal Investigator:
- HYUNG-JU CHO
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Seoul, South Korea, 08308
- Not yet recruiting
- Korea University Guro Hospital
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Principal Investigator:
- IL-HO PARK
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Seoul, South Korea, 05505
- Not yet recruiting
- Asan Medical Center
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Principal Investigator:
- Yoo-Sam Chung
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Guadalajara, Spain, 19002
- Recruiting
- Hospital Universitario de Guadalajara
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Contact:
- Phone Number: 0034949209200
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Principal Investigator:
- Olga Mediano
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Lleida, Spain, 25198
- Recruiting
- Hospital Universitari de Santa Maria
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Principal Investigator:
- Ferran Barbé Illa
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Contact:
- Phone Number: +34 (973) 70 53 72
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Logroño, Spain, 26006
- Not yet recruiting
- Hospital San Pedro
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Contact:
- Phone Number: 677151261
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Principal Investigator:
- Alejandra Roncero Lázaro
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Madrid, Spain, 28034
- Recruiting
- Hospital Universitario Ramon y Cajal
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Principal Investigator:
- Irene Cano Pumarega
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Madrid, Spain, 28046
- Not yet recruiting
- Hospital Universitario La Paz
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Contact:
- Phone Number: +34917277011
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Principal Investigator:
- Francisco Fran
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Madrid, Spain, 28036
- Recruiting
- Instituto de Investigaciones del Sueno
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Contact:
- Phone Number: 913454129
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Principal Investigator:
- Diego Garcia Borreguero
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Málaga, Spain, 29010
- Not yet recruiting
- Hospital Universitario Virgen de la Victoria
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Principal Investigator:
- Francisco Tinahones Madueno
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Contact:
- Phone Number: 951032734
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Seville, Spain, 41013
- Recruiting
- Hospital Universitario Virgen del Rocio
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Principal Investigator:
- Candelaria Caballero Eraso
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Seville, Spain, 41010
- Not yet recruiting
- Hospital Quiron Infanta Luisa
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Contact:
- Phone Number: 670502836
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Principal Investigator:
- MARGARITA RIVAS FERNANDEZ
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Taichung, Taiwan, 40447
- Not yet recruiting
- China Medical University Hospital
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Contact:
- Phone Number: +886975681003
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Principal Investigator:
- Liang-Wen Hang
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Tainan, Taiwan, 704
- Not yet recruiting
- National Cheng-Kung Uni. Hosp.
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Principal Investigator:
- Yi-Ching Yang
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Contact:
- Phone Number: 886 62353535 ext 3985
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Taoyuan, Taiwan, 333
- Not yet recruiting
- Chang Gung Medical Foundation-Linkou Branch
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Contact:
- Phone Number: 033281200 ext.3966
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Principal Investigator:
- Hsueh-Yu Li
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Alabama
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Cullman, Alabama, United States, 35055
- Recruiting
- Cullman Clinical Trials
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Principal Investigator:
- Randall Quinn
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Contact:
- Phone Number: 256-708-2826
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California
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Long Beach, California, United States, 90815
- Recruiting
- Ark Clinical Research
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Principal Investigator:
- Apinya Vutikullird
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Contact:
- Phone Number: 562-997-1000
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Los Alamitos, California, United States, 90720
- Recruiting
- Collaborative Neuroscience Research, LLC
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Contact:
- Phone Number: 714-799-7799
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Principal Investigator:
- Steven Reynolds
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Riverside, California, United States, 92503
- Recruiting
- Artemis Institute for Clinical Research
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Contact:
- Phone Number: 951-374-1190
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Principal Investigator:
- Jack Vu
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Colorado
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Aurora, Colorado, United States, 80012
- Recruiting
- Care Access - Aurora
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Principal Investigator:
- Mauricio Waintrub
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Contact:
- Phone Number: 720-368-4865
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Florida
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Miami, Florida, United States, 33176
- Recruiting
- PharmaDev Clinical Research Institute, LLC
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Contact:
- Phone Number: 305-420-5636
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Principal Investigator:
- Edward Mezerhane
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Miami, Florida, United States, 33135
- Recruiting
- Flourish Research - Miami, LLC
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Contact:
- Phone Number: 305-631-6704
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Principal Investigator:
- Mark Rosenthal
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Pensacola, Florida, United States, 32504
- Recruiting
- Emerald Coast Neurology - Airport Boulevard
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Contact:
- Phone Number: 850-438-1136
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Principal Investigator:
- David Bear
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Georgia
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Lawrenceville, Georgia, United States, 30043
- Recruiting
- Teak Research Consults
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Principal Investigator:
- Kamar Alabi
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Snellville, Georgia, United States, 30078
- Recruiting
- EBGS Clinical Research Center
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Principal Investigator:
- Aliu Sanni
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Contact:
- Phone Number: 770-729-4517
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Louisiana
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Shreveport, Louisiana, United States, 71105
- Recruiting
- Care Access - Shreveport 2
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Principal Investigator:
- David Green
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Contact:
- Phone Number: 318-209-3290
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Maryland
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Bowie, Maryland, United States, 20715
- Recruiting
- Flourish Research - Bowie
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Principal Investigator:
- BARBARA HUTCHINSON
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Contact:
- Phone Number: 410-824-1342
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Michigan
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Southfield, Michigan, United States, 48075
- Recruiting
- Revive Research Institute, Inc.
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Principal Investigator:
- Syed Raza
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Contact:
- Phone Number: 248-829-3103
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Minnesota
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Maplewood, Minnesota, United States, 55109
- Recruiting
- Headlands Research-Twin Cities
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Principal Investigator:
- Charlene McEvoy
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Missouri
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St Louis, Missouri, United States, 63123
- Recruiting
- Clayton Sleep Institute - St. Louis - Tesson Ferry Road
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Contact:
- Phone Number: 314-645-6005
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Principal Investigator:
- Joseph Ojile
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Nevada
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Las Vegas, Nevada, United States, 89128
- Recruiting
- Palm Research Center Tenaya
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Contact:
- Phone Number: 702-736-5161
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Principal Investigator:
- Samer Nakhle
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New Mexico
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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
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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)
|
Administered SC
Other Names:
|
|
Placebo Comparator: Placebo (YSA1)
Participants will receive placebo SC
|
Administered SC
|
|
Experimental: Eloralintide (YSA2)
Participants will receive eloralintide SC
|
Administered SC
Other Names:
|
|
Placebo Comparator: Placebo (YSA2)
Participants will receive placebo SC
|
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
Sponsor
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Nutrition Disorders
- Overnutrition
- Body Weight
- Respiratory Tract Diseases
- Respiration Disorders
- Sleep Wake Disorders
- Apnea
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Apnea Syndromes
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Overweight
- Obesity
- Sleep Apnea, Obstructive
Other Study ID Numbers
- 27764
- 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)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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