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

Официальное название

A Master Protocol for Phase 3 Randomized, Double-Blind, Placebo-Controlled Studies to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Moderate to Severe Obstructive Sleep Apnea, and Obesity or Overweight

Обзор

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.

Вмешательства

• Препарат Eloralintide
  Administered SC
• Препарат Placebo
  Administered SC

Первичные конечные точки

• Percent Change from Baseline in Body Weight [Срок оценки: Baseline, Week 64]
• Change from Baseline in Apnea-Hypopnea Index (AHI) [Срок оценки: Baseline, Week 64]

Вторичные конечные точки (12)

• Change from Baseline in Systolic Blood Pressure (SBP) [Срок оценки: Baseline, Week 64]
• Percent Change from Baseline in Triglycerides [Срок оценки: Baseline, Week 64]
• Percent Change from Baseline in High Sensitivity C-Reactive Protein (hsCRP) [Срок оценки: Baseline, Week 64]
• Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Sleep-Related Impairment 8a T-Score [Срок оценки: Baseline, Week 64]
• Achievement of AHI <5 or AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤ 10 [Срок оценки: Baseline, Week 64]
• Percent Change from Baseline in Sleep Apnea Specific Hypoxic Burden (SASHB) [Срок оценки: Baseline, Week 64]
• Number of Participants who Achieve ≥50% decrease in AHI [Срок оценки: Baseline, Week 64]
• Change from Baseline in Body Mass Index (BMI) [Срок оценки: Baseline, Week 64]
• Change from Baseline in Fasting Glucose [Срок оценки: Baseline, Week 64]
• Change from Baseline in ESS Score [Срок оценки: Baseline, Week 64]
• Change from Baseline in Short Form-36 (SF-36 v2) Scores [Срок оценки: Baseline, Week 64]
• Change from Baseline in EQ-5D-5L Scores [Срок оценки: Baseline, Week 64]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 23 центра

• Cullman Clinical Trials — Cullman
• Ark Clinical Research — Long Beach
• Collaborative Neuroscience Research, LLC — Los Alamitos
• Artemis Institute for Clinical Research — Riverside
• Care Access - Aurora — Aurora
• Flourish Research - Miami, LLC — Miami
• PharmaDev Clinical Research Institute, LLC — Miami
• Emerald Coast Neurology - Airport Boulevard — Pensacola
• … и ещё 15 центров

Китай · 22 центра

• China-Japan Friendship Hospital — Пекин
• The First Hospital of Jilin University — Changchun
• The Second Hospital of Jilin University — Changchun
• The Third Xiangya Hospital of Central South University — Чанша
• Sichuan Provincial People's Hospital — Чэнду
• The First Affiliated Hospital of Chongqing Medical University — Чунцин
• The First Affiliated Hospital of Guangzhou Medical University — Гуанчжоу
• The Second People's Hospital of Hefei — Хэфэй
• … и ещё 14 центров

Индия · 12 центров

• SDS Tuberculosis Research Center & Rajiv Gandhi Institute of Chest Diseases — Bengaluru
• St. Johns Medical College Hospital — Bengaluru
• Utkal Institute of Medical Sciences and Hospital — Bhubaneswar
• … и ещё 9 центров

Бразилия · 10 центров

• Instituto de Pesquisa clinica de Campinas — Campinas
• Centro de Pesquisa Clínica de Marília - CPCLIM — Marília
• Núcleo de Pesquisa Clínica do Rio Grande do Sul — Porto Alegre
• CEMER - Centro Médico do Recife — Recife
• Ruschel Medicina e Pesquisa Clínica — Rio de Janeiro
• Prognosis Pesquisa Clínica — Santo André
• CPHosp Medicina, Ensino e Pesquisa (CPQuali) — São Paulo
• BR Trials - Ensaios Clinicos e Consultoria — São Paulo
• … и ещё 2 центра

Япония · 10 центров

Список центров уточняется — проверьте первичный протокол.

Испания · 9 центров

Список центров уточняется — проверьте первичный протокол.

Австралия · 8 центров

• Nightingale Research — Adelaide
• Flinders University — Bedford Park
• Box Hill Hospital — Box Hill
• Core Research Group — Brisbane
• Austin Health - Repatriation Hospital — Heidelberg West
• CDH Research Institute Pty Ltd — Maroochydore
• Gold Coast University Hospital — Southport
• TrialsWest - Spearwood — Spearwood

Германия · 8 центров

• CIMS Studienzentrum Bamberg — Bamberg
• Advanced Sleep Research — Berlin
• InnoDiab Forschung Gmbh — Essen
• Siteworks GmbH - Hannover — Hanover
• Siteworks - Karlsruhe — Karlsruhe
• Universitätsklinikum Marburg — Marburg
• RED-Institut GmbH — Oldenburg
• Somni bene — Schwerin

Канада · 6 центров

• MyCliniResearch, Inc. — Calgary
• Alpha Recherche Clinique - Lévis — Lévis
• Alpha Recherche Clinique — Québec
• C.I.C. Saint-Laurent — Saint-Laurent
• Maple Leaf Research — Toronto
• C.I.C. Mauricie inc. — Trois-Rivières

South Korea · 4 центра

Список центров уточняется — проверьте первичный протокол.

Тайвань · 3 центра

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07369011 · 27764 · J3R-MC-YDAO · J3R-MC-YSA1 · J3R-MC-YSA2 · 2025-523769-11-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗