Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) Therapy

Официальное название

A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure Therapy and Living With Overweight or Obesity (MARITIME-OSA-2)

Обзор

This Phase 3 clinical trial is designed to evaluate the efficacy and safety of maridebart cafraglutide compared to placebo over a 52-week period in adults with obstructive sleep apnea (OSA) who are not on PAP therapy and are living with overweight or obesity.

Вмешательства

• Препарат Maridebart cafraglutide
  Participants will receive maridebart cafraglutide SC.
• Препарат Placebo
  Participants will receive placebo SC.

Первичные конечные точки

• Change in Apnea-hypopnea Index (AHI) from baseline at Week 52 [Срок оценки: At Week 52]

Вторичные конечные точки (8)

• Percent Change in AHI from baseline at Week 52 [Срок оценки: At Week 52]
• Participants Achieving ≥ 50% AHI Reduction from baseline at Week 52 [Срок оценки: At Week 52]
• Participants Achieving AHI < 5 or AHI 5 to 14 with Epworth Sleepiness Scale (ESS) ≤ 10 from baseline at Week 52 [Срок оценки: At Week 52]
• Percent Change in Body Weight from baseline at Week 52 [Срок оценки: At Week 52]
• Change in Sleep Apnea-specific Hypoxic Burden (SASHB) from baseline at Week 52 [Срок оценки: At Week 52]
• Change in High Sensitivity C-reactive Protein (hs-CRP) from baseline at Week 52 [Срок оценки: At Week 52]
• Change in Systolic Blood Pressure (SBP) from baseline at Week 48 [Срок оценки: At Week 48]
• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Sleep-related Impairment 8a Score from baseline at Week 52 [Срок оценки: At Week 52]

Критерии участия

Критерии включения

• Participants must have an AHI of 15 or higher on polysomnography (PSG) at Day 1 before randomization.
• Body Mass Index (BMI) of 27 kg/m\^2 or more at the time of screening.
• History of at least one unsuccessful attempt at weight loss through diet and exercise.
• Participants must not have used PAP therapy for at least 4 weeks before screening, are unwilling/unable to use PAP, and do not plan to use PAP therapy during the study.

Критерии исключения

• Individuals who have had any previous or planned upper airway surgery for sleep apnea or major ear, nose, or throat surgery.
• Those with significant craniofacial abnormalities that may affect breathing at screening.
• Participants diagnosed with Central Apnea with a percentage of central apneas/hypopneas of 50% or more, or those diagnosed with Cheyne Stokes Respiration.
• Active device treatment of OSA (eg, PAP, oral appliances), or other treatments, that in the opinion of the investigator, may interfere with study outcomes, unless willing to stop treatment at screening and throughout the study.
• Individuals with respiratory diseases like obesity hypoventilation syndrome or daytime hypercapnia, neuromuscular diseases or other conditions that could interfere with the trial results, according to the investigator's opinion.

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 · 13 центров

• Valley Clinical Trials — Northridge
• Peninsula Research Associates — Rolling Hills Estates
• Teradan Clinical Trials — Brandon
• Destiny Research Center — Palmetto Bay
• Clinical Research Center Of Florida — Pompano Beach
• NeuroTrials Research — Atlanta
• Basil Clinical — Laurelton
• Monroe Biomedical Research — Monroe
• … и ещё 5 центров

Япония · 9 центров

• Saiseikai Futsukaichi Hospital — Chikushino-shi
• Fukuoka University Hospital — Fukuoka
• Mazda Hospital of Mazda Motor Corporation — Aki-gun
• Sleep and Mental Clinic-Kitahiroshima — Kitahiroshima-shi
• RESM ShinYokohama Sleep and Respiratory Medical Care Clinic — Yokohama
• Kuwamizu Hospital — Kumamoto
• Nakamura Clinic — Urasoe-shi
• Gokeikai Osaka Kaisei Hospital — Osaka
• … и ещё 1 центр

Германия · 6 центров

• Advanced Sleep Research — Berlin
• InnoDiab Forschung — Essen
• Diabeteszentrum Hamburg West — Hamburg
• Siteworks - Zentrum fuer klinische Studien Hannover — Hanover
• Siteworks - Zentrum fuer klinische Studien Karlsruhe — Karlsruhe
• Red-Institut GmbH — Oldenburg

Испания · 5 центров

• Centro Medico Teknon — Barcelona
• Hospital Universitari Vall d Hebron — Barcelona
• Hospital Medico Quirurgico San Rafael — A Coruña
• Hospital Quiron Madrid — Pozuelo de Alarcón
• Hospital Universitario 12 de Octubre — Madrid

Бразилия · 4 центра

• Nucleo de Pesquisa do Rio Grande do Sul — Porto Alegre
• Instituto de Pesquisa Clinica de Campinas - Ipecc — Campinas
• CPQuali Pesquisa Clinica Ltda — São Paulo
• Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo Hcfmusp — São Paulo

Канада · 4 центра

• CaRe Clinic — Calgary
• Aggarwal and Associates Ltd — Brampton
• Wharton Medical Clinic — Hamilton
• Diex Recherche Trois Rivieres — Trois-Rivières

Австралия · 3 центра

• Woolcock Institute of Medical Research — Macquarie Park
• Royal Brisbane and Womens Hospital — Herston
• Monash Medical Centre — Clayton

Чехия · 3 центра

• Nemocnice Rudolfa a Stefanie Benesov as — Benesov U Prahy
• Fakultni nemocnice Brno — Brno
• Cerebrovaskularni poradna sro — Ostrava - Poruba

Франция · 3 центра

• Centre Hospitalier Universitaire d'Angers — Angers
• Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin — Bordeaux
• Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon — Grenoble

Венгрия · 3 центра

• SomnoCenter Budapest Alvaszavar Kozpont — Budapest
• Debreceni Egyetem Klinikai Kozpont — Debrecen
• Reformatus Pulmonologiai Centrum — Törökbálint

Польша · 1 центр

• Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy — Warsaw

Идентификаторы

NCT: NCT07226765 · 20250002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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