Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) Therapy
Phase 3 – large-scale trial before approval
Conditions:
Obstructive Sleep Apnea
Sponsor: Amgen
trial.available_in:
БГ
Overview
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.
Who can participate
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Interventions
Maridebart cafraglutide
DRUG
Placebo
DRUG
Locations
38
Australia (3)
Monash Medical Centre
Clayton , Victoria
Royal Brisbane and Womens Hospital
Herston , Queensland
Woolcock Institute of Medical Research
Macquarie Park , New South Wales
Brazil (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
Canada (3)
Aggarwal and Associates Ltd
Brampton , Ontario
CaRe Clinic
Calgary , Alberta
Wharton Medical Clinic
Hamilton , Ontario
Czech Republic (2)
Nemocnice Rudolfa a Stefanie Benesov as
Benesov U Prahy
Cerebrovaskularni poradna sro
Ostrava - Poruba
Germany (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
Japan (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
Poland (1)
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy