Last updated 4 days ago
A Study of Eloralintide (LY3841136) in Participants With Obstructive Sleep Apnea and Obesity or Overweight
800 patients around the world
Available in Argentina, United States, Brazil
Eli Lilly and Company
20Research sites
800Patients around the world
This study is for people with
Sleep disorders
Sleep apnea
Obesity
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.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.
Sites
Centro de Investigaciones Clínicas Baigorria
Centro de Investigaciones Metabólicas (CINME) S.A. - CABA, Buenos Aires
Centro Médico Maffei - CABA, Buenos Aires
Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Médica - Rosario, Santa Fe
STAT Research - CABA
Centro Médico Viamonte SRL - CABA, Buenos Aires
Centro Integral de Medicina Respiratoria (CIMER) - Tucumán
Consultorio de Investigación Clínica EMO SRL
Fundación Respirar
Instituto Médico Río Cuarto
StudyENLIGHTEN-3
SponsorEli Lilly and Company
Study typeInterventional
Conditions
Sleep apneaObesity
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07369011
