A Study of Eloralintide (LY3841136) in Participants With Obstructive Sleep Apnea and Obesity or Overweight
Recruiting · NCT07369011 · Interventional (participants receive a specific treatment) · Lead sponsor: Eli Lilly and Company
View the official record on ClinicalTrials.gov →Interventions studied
EloralintidePlacebo
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 16 US states.
- Cullman Clinical Trials - Cullman, Alabama, United States
- Ark Clinical Research - Long Beach, California, United States
- Collaborative Neuroscience Research, LLC - Los Alamitos, California, United States
- Artemis Institute for Clinical Research - Riverside, California, United States
- Care Access - Aurora - Aurora, Colorado, United States
- Flourish Research - Miami, LLC - Miami, Florida, United States
- PharmaDev Clinical Research Institute, LLC - Miami, Florida, United States
- Emerald Coast Neurology - Airport Boulevard - Pensacola, Florida, United States
- Teak Research Consults - Lawrenceville, Georgia, United States
- EBGS Clinical Research Center - Snellville, Georgia, United States
- Care Access - Shreveport 2 - Shreveport, Louisiana, United States
- Flourish Research - Bowie - Bowie, Maryland, United States
- Revive Research Institute, Inc. - Southfield, Michigan, United States
- Headlands Research-Twin Cities - Maplewood, Minnesota, United States
- Clayton Sleep Institute - St. Louis - Tesson Ferry Road - St Louis, Missouri, United States
- Palm Research Center Tenaya - Las Vegas, Nevada, United States
- The Sleep Spot - Maimonides - Albuquerque, New Mexico, United States
- Rochester Clinical Research - Buffalo - Buffalo, New York, United States
- CTI Clinical Research Center - Cincinnati, Ohio, United States
- Bogan Sleep Consultants - Columbia, South Carolina, United States
- FutureSearch Trials of Neurology - Austin, Texas, United States
- Sleep Therapy Research Center - San Antonio, Texas, United States
- Consano Clinical Research, LLC - Shavano Park, Texas, United States
- Nightingale Research - Adelaide, Australia
- Korea University Ansan Hospital - Ansan-si, South Korea
- CIMS Studienzentrum Bamberg - Bamberg, Germany
- Flinders University - Bedford Park, Australia
- China-Japan Friendship Hospital - Beijing, China
- SDS Tuberculosis Research Center & Rajiv Gandhi Institute of Chest Diseases - Bengaluru, India
- St. Johns Medical College Hospital - Bengaluru, India
- Advanced Sleep Research - Berlin, Germany
- Utkal Institute of Medical Sciences and Hospital - Bhubaneswar, India
- Box Hill Hospital - Box Hill, Australia
- Core Research Group - Brisbane, Australia
- Juntendo University Hospital - Bunkyō City, Japan
- MyCliniResearch, Inc. - Calgary, Canada
- Instituto de Pesquisa clinica de Campinas - Campinas, Brazil
- The First Hospital of Jilin University - Changchun, China
- The Second Hospital of Jilin University - Changchun, China
- The Third Xiangya Hospital of Central South University - Changsha, China
- Sichuan Provincial People's Hospital - Chengdu, China
- The First Affiliated Hospital of Chongqing Medical University - Chongqing, China
- InnoDiab Forschung Gmbh - Essen, Germany
- Fukuoka University Hospital - Fukuoka, Japan
- Hospital Universitario de Guadalajara - Guadalajara, Spain
- The First Affiliated Hospital of Guangzhou Medical University - Guangzhou, China
- Endolife Speciality Hospitals - Guntur, India
- Siteworks GmbH - Hannover - Hanover, Germany
- The Second People's Hospital of Hefei - Hefei, China
- Austin Health - Repatriation Hospital - Heidelberg West, Australia
- Siteworks - Karlsruhe - Karlsruhe, Germany
- Social Medical Corporation Sokujinkai Sleep and Mental Health Clinic - Kitahiroshima - Kitahiroshima, Japan
- Kirigaokatsuda Hospital - Kitakyushu, Japan
- The First People's Hospital of Yunnan Province - Kunming, China
- Gansu Provincial Hospital - Lanzhou, China
- Hospital Universitari de Santa Maria - Lleida, Spain
- Hospital San Pedro - Logroño, Spain
- The First Affiliated Hospital of Henan University of Science &Technology - Luoyang Shi, China
- Alpha Recherche Clinique - Lévis - Lévis, Canada
- Hospital Universitario Ramón y Cajal - Madrid, Spain
Showing 60 of 115 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →