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Набира участници Фаза 3 NCT07369011

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

Фаза 3 – широко изпитване преди одобрение
Заболявания: Sleep Apnea, Obstructive Obesity Overweight

Спонсор: Eli Lilly and Company

Налично на: БГ
Обобщение
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.
Кой може да участва
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
Места на провеждане 12
Argentina (1)
Cicemo Srl
Buenos Aires
NOT_YET_RECRUITING
Австралия (1)
Nightingale Research
Adelaide
NOT_YET_RECRUITING
Бразилия (1)
Instituto de Pesquisa clinica de Campinas
Campinas
NOT_YET_RECRUITING
Канада (1)
MyCliniResearch, Inc.
Calgary
NOT_YET_RECRUITING
Китай (1)
China-Japan Friendship Hospital
Beijing
NOT_YET_RECRUITING
Германия (1)
CIMS Studienzentrum Bamberg
Bamberg
NOT_YET_RECRUITING
Индия (1)
SDS Tuberculosis Research Center & Rajiv Gandhi Institute of Chest Diseases
Bengaluru
NOT_YET_RECRUITING
Япония (1)
Juntendo University Hospital
Bunkyō City
NOT_YET_RECRUITING
Южна Корея (1)
Korea University Ansan Hospital
Ansan-si
NOT_YET_RECRUITING
Испания (1)
Hospital Universitario de Guadalajara
Guadalajara
NOT_YET_RECRUITING
Taiwan (1)
China Medical University Hospital
Taichung
NOT_YET_RECRUITING
САЩ (1)
Cullman Clinical Trials
Cullman , Alabama
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
10.02.2026
Крайна дата
01.04.2028
Регистрационен номер
NCT07369011
Източник
anzctr
Запитване за медицински туризъм

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