Clinical trial
Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) Therapy
Recruiting now · Phase 3 · 10 countries · Registry ID NCT07226765
Recruiting nowPhase 3Interventional
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 99 Years
SexAll
Healthy volunteersNot accepted
ConditionObstructive Sleep Apnea
Full registry criteria
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 or major ear, nose or throat surgery for OSA. * Those with significant craniofacial abnormalities that may affect breathing at screening. * Participants diagnosed with Central or Mixed Sleep Apnea with proportion of mixed or central apneas/hypopneas ≥ 50%, and/or diagnosis of Cheyne Stokes Respiration. * Active device treatment of OSA or other treatments, that in the opinion of the investigator, may interfere with study outcomes. * 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.
Treatments and study arms
Maridebart cafraglutide
Drug
Participants will receive maridebart cafraglutide SC.
Placebo
Drug
Participants will receive placebo SC.
Primary outcomes
Change in Apnea-hypopnea Index (AHI) from baseline at Week 52At Week 52
Study locations
57 locations were listed when this page was built. The first 40 are shown.
Monash Medical Centre🇦🇺 Clayton, Victoria, Australia
Royal Brisbane and Womens Hospital🇦🇺 Herston, Queensland, Australia
Woolcock Institute of Medical Research🇦🇺 Macquarie Park, New South Wales, Australia
Instituto de Pesquisa Clinica de Campinas - Ipecc🇧🇷 Campinas, São Paulo, Brazil
Nucleo de Pesquisa do Rio Grande do Sul🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil
CPQuali Pesquisa Clinica Ltda🇧🇷 São Paulo, São Paulo, Brazil
Centro Paulista de Investigacao Clinica Cepic🇧🇷 São Paulo, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo Hcfmusp🇧🇷 São Paulo, São Paulo, Brazil
Aggarwal and Associates Ltd🇨🇦 Brampton, Ontario, Canada
CaRe Clinic🇨🇦 Calgary, Alberta, Canada
Wharton Medical Clinic🇨🇦 Hamilton, Ontario, Canada
Diex Recherche Trois Rivieres🇨🇦 Trois-Rivières, Quebec, Canada
Nemocnice Rudolfa a Stefanie Benesov as🇨🇿 Benesov U Prahy, Czechia
Fakultni nemocnice Brno🇨🇿 Brno, Czechia
Cerebrovaskularni poradna sro🇨🇿 Ostrava - Poruba, Czechia
Centre Hospitalier Universitaire d'Angers🇫🇷 Angers, France
Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin🇫🇷 Bordeaux, France
Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon🇫🇷 Grenoble, France
Advanced Sleep Research🇩🇪 Berlin, Germany
InnoDiab Forschung🇩🇪 Essen, Germany
Diabeteszentrum Hamburg West🇩🇪 Hamburg, Germany
Siteworks - Zentrum fuer klinische Studien Hannover🇩🇪 Hanover, Germany
Siteworks - Zentrum fuer klinische Studien Karlsruhe🇩🇪 Karlsruhe, Germany
Red-Institut GmbH🇩🇪 Oldenburg, Germany
SomnoCenter Budapest Alvaszavar Kozpont🇭🇺 Budapest, Hungary
Debreceni Egyetem Klinikai Kozpont🇭🇺 Debrecen, Hungary
Reformatus Pulmonologiai Centrum🇭🇺 Törökbálint, Hungary
Mazda Hospital of Mazda Motor Corporation🇯🇵 Aki-gun, Hiroshima, Japan
Saiseikai Futsukaichi Hospital🇯🇵 Chikushino-shi, Fukuoka, Japan
Fukuoka University Hospital🇯🇵 Fukuoka, Fukuoka, Japan
Sleep and Mental Clinic-Kitahiroshima🇯🇵 Kitahiroshima-shi, Hokkaido, Japan
Kuwamizu Hospital🇯🇵 Kumamoto, Kumamoto, Japan
Goodsleep Clinic🇯🇵 Minato-ku, Tokyo, Japan
Gokeikai Osaka Kaisei Hospital🇯🇵 Osaka, Osaka, Japan
Nakamura Clinic🇯🇵 Urasoe-shi, Okinawa, Japan
RESM ShinYokohama Sleep and Respiratory Medical Care Clinic🇯🇵 Yokohama, Kanagawa, Japan
Uniwersytecki Szpital Kliniczny w Bialymstoku🇵🇱 Bialystok, Poland
Uniwersytecki Szpital Kliniczny w Poznaniu🇵🇱 Poznan, Poland
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy🇵🇱 Warsaw, Poland
Hospital Medico Quirurgico San Rafael🇪🇸 A Coruña, Galicia, Spain