Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy
Фаза 3 – широко изпитване преди одобрение
Заболявания:
Obesity
Obstructive Sleep Apnea
Спонсор: Amgen
Налично на:
БГ
Обобщение
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 receiving positive airway pressure (PAP) therapy and are living with overweight or obesity.
Кой може да участва
Inclusion Criteria:
* AHI ≥ 15 on polysomnography at day 1 before randomization.
* BMI ≥ 27 kg/m\^2 at screening.
* History of at least 1 unsuccessful attempt at weight loss by diet and exercise.
* On positive airway pressure (PAP) therapy for at least 3 consecutive months before screening and plan to continue PAP therapy during the trial.
Exclusion Criteria:
* Had any previous or planned upper airway surgery for sleep apnea or major ear, nose, or throat surgery.
* Significant craniofacial abnormalities that may affect breathing at screening.
* Diagnosis of Central Apnea with % of central apneas/hypopneas ≥ 50%, and/or diagnosis of Cheyne Stokes Respiration.
* Active device treatment of obstructive sleep apnea other than PAP therapy (eg, oral appliances), or other treatments, that in the opinion of the investigator, may interfere with trial outcomes, unless willing to stop treatment at screening and throughout the trial.
* Respiratory diseases such as obesity hypoventilation syndrome or daytime hypercapnia, or neuromuscular diseases such as myasthenia gravis or other conditions that could interfere with the results of the trial in the opinion of the investigator.
* Have personal circumstances or job-related responsibilities that prevent a 7-day PAP withdrawal before polysomnography testing during the course of the trial.
Интервенции
Maridebart cafraglutide
DRUG
Placebo
DRUG
Места на провеждане
47
Австралия (3)
Monash Medical Centre
Clayton , Victoria
Royal Brisbane and Womens Hospital
Herston , Queensland
Woolcock Institute of Medical Research
Macquarie Park , New South Wales
Бразилия (2)
Nucleo de Pesquisa do Rio Grande do Sul
Porto Alegre , Rio Grande do Sul
Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo Hcfmusp
São Paulo , São Paulo
Канада (3)
Aggarwal and Associates Ltd
Brampton , Ontario
CaRe Clinic
Calgary , Alberta
Wharton Medical Clinic
Hamilton , Ontario
Чехия (2)
Nemocnice Rudolfa a Stefanie Benesov as
Benesov U Prahy
Cerebrovaskularni poradna sro
Ostrava - Poruba
Франция (4)
Centre Hospitalier Universitaire d'Angers
Angers
Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin
Bordeaux
Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon
Grenoble
Hospices Civils de Lyon - Centre Hospitalier Lyon Sud
Pierre-Bénite
Германия (6)
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
Унгария (5)
SomnoCenter Budapest Alvaszavar Kozpont
Budapest
Debreceni Egyetem Klinikai Kozpont
Debrecen
Erzsebet Gondozohaz
Gödöllő
SomnoCenter Szeged Alvaszavar Kozpont
Szeged
Reformatus Pulmonologiai Centrum
Törökbálint
Япония (5)
Saiseikai Futsukaichi Hospital
Chikushino-shi , Fukuoka
Fukuoka University Hospital
Fukuoka , Fukuoka
Sleep and Mental Clinic-Kitahiroshima
Kitahiroshima-shi , Hokkaido
Kuwamizu Hospital
Kumamoto , Kumamoto
Nakamura Clinic
Urasoe-shi , Okinawa
Полша (1)
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy