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Clinical Trials in India / NCT07369011
Recruiting Phase 3

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

NCT07369011 · tracked via the Priya Life Science India tracker
Sponsor
Eli Lilly and Company
Phase
Phase 3
Started
2026-02-10
Last updated
2026-09-08

Condition(s) studied

Sleep Apnea, ObstructiveObesityOverweight

Investigational drug(s) / intervention(s)

EloralintidePlacebo

Eloralintide: Administered SC

Placebo: Administered SC

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (115)

FacilityCityRegionStatus
Cullman Clinical Trials Cullman Alabama Recruiting
Ark Clinical Research Long Beach California Recruiting
Collaborative Neuroscience Research, LLC Los Alamitos California Recruiting
Artemis Institute for Clinical Research Riverside California Recruiting
Care Access - Aurora Aurora Colorado Recruiting
Flourish Research - Miami, LLC Miami Florida Recruiting
PharmaDev Clinical Research Institute, LLC Miami Florida Recruiting
Emerald Coast Neurology - Airport Boulevard Pensacola Florida Recruiting
Teak Research Consults Lawrenceville Georgia Recruiting
EBGS Clinical Research Center Snellville Georgia Recruiting
Care Access - Shreveport 2 Shreveport Louisiana Recruiting
Flourish Research - Bowie Bowie Maryland Recruiting
Revive Research Institute, Inc. Southfield Michigan Recruiting
Headlands Research-Twin Cities Maplewood Minnesota Recruiting
Clayton Sleep Institute - St. Louis - Tesson Ferry Road St Louis Missouri Recruiting
Palm Research Center Tenaya Las Vegas Nevada Recruiting
The Sleep Spot - Maimonides Albuquerque New Mexico Recruiting
Rochester Clinical Research - Buffalo Buffalo New York Recruiting
CTI Clinical Research Center Cincinnati Ohio Recruiting
Bogan Sleep Consultants Columbia South Carolina Recruiting
FutureSearch Trials of Neurology Austin Texas Recruiting
Sleep Therapy Research Center San Antonio Texas Recruiting
Consano Clinical Research, LLC Shavano Park Texas Recruiting
Nightingale Research Adelaide Australia Recruiting
Flinders University Bedford Park Australia Recruiting
Box Hill Hospital Box Hill Australia Recruiting
Core Research Group Brisbane Australia Recruiting
Austin Health - Repatriation Hospital Heidelberg West Australia Recruiting
CDH Research Institute Pty Ltd Maroochydore Australia Recruiting
Gold Coast University Hospital Southport Australia Recruiting
TrialsWest - Spearwood Spearwood Australia Recruiting
Instituto de Pesquisa clinica de Campinas Campinas Brazil Suspended
Centro de Pesquisa Clínica de Marília - CPCLIM Marília Brazil Suspended
Núcleo de Pesquisa Clínica do Rio Grande do Sul Porto Alegre Brazil Suspended
CEMER - Centro Médico do Recife Recife Brazil Suspended
Ruschel Medicina e Pesquisa Clínica Rio de Janeiro Brazil Suspended
Prognosis Pesquisa Clínica Santo André Brazil Suspended
CPHosp Medicina, Ensino e Pesquisa (CPQuali) São Paulo Brazil Suspended
BR Trials - Ensaios Clinicos e Consultoria São Paulo Brazil Suspended
CEPIC - Centro Paulista de Investigação Clínica São Paulo Brazil Suspended

+ 75 more sites — see the full list on the official registry below.

More Eli Lilly and Company trials in India

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07369011 on ClinicalTrials.gov ↗ ← All trials in India