Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) Therapy
Recruiting · NCT07226765 · Interventional (participants receive a specific treatment) · Lead sponsor: Amgen
View the official record on ClinicalTrials.gov →Interventions studied
Maridebart cafraglutidePlacebo
What this trial 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.
Who can take part
Age range
18 Years to 99 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
57 locations listed across 8 US states.
- Valley Clinical Trials - Northridge, California, United States
- Peninsula Research Associates - Rolling Hills Estates, California, United States
- Teradan Clinical Trials - Brandon, Florida, United States
- Destiny Research Center - Palmetto Bay, Florida, United States
- Clinical Research Center Of Florida - Pompano Beach, Florida, United States
- NeuroTrials Research - Atlanta, Georgia, United States
- Basil Clinical - Laurelton, New York, United States
- Monroe Biomedical Research - Monroe, North Carolina, United States
- CTI Clinical Research Center - Cincinnati, Ohio, United States
- FutureSearch Trials of Neurology - Austin, Texas, United States
- Epic Medical Research - DeSoto - DeSoto, Texas, United States
- Sleep Therapy & Research Center - San Antonio, Texas, United States
- Northwest Clinical Research Center - Bellevue, Washington, United States
- Centre Hospitalier Universitaire d'Angers - Angers, France
- Nemocnice Rudolfa a Stefanie Benesov as - Benesov U Prahy, Czechia
- Advanced Sleep Research - Berlin, Germany
- Uniwersytecki Szpital Kliniczny w Bialymstoku - Bialystok, Poland
- Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin - Bordeaux, France
- Fakultni nemocnice Brno - Brno, Czechia
- SomnoCenter Budapest Alvaszavar Kozpont - Budapest, Hungary
- Debreceni Egyetem Klinikai Kozpont - Debrecen, Hungary
- InnoDiab Forschung - Essen, Germany
- Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon - Grenoble, France
- Diabeteszentrum Hamburg West - Hamburg, Germany
- Siteworks - Zentrum fuer klinische Studien Hannover - Hanover, Germany
- Siteworks - Zentrum fuer klinische Studien Karlsruhe - Karlsruhe, Germany
- Hospital Universitario 12 de Octubre - Madrid, Spain
- Red-Institut GmbH - Oldenburg, Germany
- Cerebrovaskularni poradna sro - Ostrava - Poruba, Czechia
- Uniwersytecki Szpital Kliniczny w Poznaniu - Poznan, Poland
- Centro Paulista de Investigacao Clinica Cepic - São Paulo, Brazil
- Reformatus Pulmonologiai Centrum - Törökbálint, Hungary
- Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy - Warsaw, Poland
- CaRe Clinic - Calgary, Alberta, Canada
- Centro Medico Teknon - Barcelona, Catalonia, Spain
- Hospital Universitari Vall d Hebron - Barcelona, Catalonia, Spain
- Saiseikai Futsukaichi Hospital - Chikushino-shi, Fukuoka, Japan
- Fukuoka University Hospital - Fukuoka, Fukuoka, Japan
- Hospital Medico Quirurgico San Rafael - A Coruña, Galicia, Spain
- Mazda Hospital of Mazda Motor Corporation - Aki-gun, Hiroshima, Japan
- Sleep and Mental Clinic-Kitahiroshima - Kitahiroshima-shi, Hokkaido, Japan
- RESM ShinYokohama Sleep and Respiratory Medical Care Clinic - Yokohama, Kanagawa, Japan
- Kuwamizu Hospital - Kumamoto, Kumamoto, Japan
- Hospital Quiron Madrid - Pozuelo de Alarcón, Madrid, Spain
- Woolcock Institute of Medical Research - Macquarie Park, New South Wales, Australia
- Nakamura Clinic - Urasoe-shi, Okinawa, Japan
- Aggarwal and Associates Ltd - Brampton, Ontario, Canada
- Wharton Medical Clinic - Hamilton, Ontario, Canada
- Gokeikai Osaka Kaisei Hospital - Osaka, Osaka, Japan
- Diex Recherche Trois Rivieres - Trois-Rivières, Quebec, Canada
- Royal Brisbane and Womens Hospital - Herston, Queensland, Australia
- Nucleo de Pesquisa do Rio Grande do Sul - Porto Alegre, Rio Grande do Sul, Brazil
- Instituto de Pesquisa Clinica de Campinas - Ipecc - Campinas, São Paulo, Brazil
- CPQuali Pesquisa Clinica Ltda - São Paulo, São Paulo, Brazil
- Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo Hcfmusp - São Paulo, São Paulo, Brazil
- Goodsleep Clinic - Minato-ku, Tokyo, Japan
- Monash Medical Centre - Clayton, Victoria, Australia