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Recruiting Phase 3 NCT07369011

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

Phase 3 – large-scale trial before approval
Conditions: Sleep Apnea, Obstructive Obesity Overweight

Sponsor: Eli Lilly and Company

trial.available_in: БГ
Overview
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 participate
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
Locations 12
Argentina (1)
Cicemo Srl
Buenos Aires
NOT_YET_RECRUITING
Australia (1)
Nightingale Research
Adelaide
NOT_YET_RECRUITING
Brazil (1)
Instituto de Pesquisa clinica de Campinas
Campinas
NOT_YET_RECRUITING
Canada (1)
MyCliniResearch, Inc.
Calgary
NOT_YET_RECRUITING
China (1)
China-Japan Friendship Hospital
Beijing
NOT_YET_RECRUITING
Germany (1)
CIMS Studienzentrum Bamberg
Bamberg
NOT_YET_RECRUITING
India (1)
SDS Tuberculosis Research Center & Rajiv Gandhi Institute of Chest Diseases
Bengaluru
NOT_YET_RECRUITING
Japan (1)
Juntendo University Hospital
Bunkyō City
NOT_YET_RECRUITING
South Korea (1)
Korea University Ansan Hospital
Ansan-si
NOT_YET_RECRUITING
Spain (1)
Hospital Universitario de Guadalajara
Guadalajara
NOT_YET_RECRUITING
Taiwan (1)
China Medical University Hospital
Taichung
NOT_YET_RECRUITING
United States (1)
Cullman Clinical Trials
Cullman , Alabama
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
10.02.2026
Completion date
01.04.2028
Registry ID
NCT07369011
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.