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Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy
Sponsor: Amgen
Summary
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.
Official title: 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 on Positive Airway Pressure Therapy and Living With Overweight or Obesity
Key Details
Gender
All
Age Range
18 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
250
Start Date
2025-12-19
Completion Date
2028-09-13
Last Updated
2026-04-09
Healthy Volunteers
No
Conditions
Interventions
Maridebart cafraglutide
Participants will receive maridebart cafraglutide as SC injections.
Placebo
Participants will receive placebo SC.
Locations (43)
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
Woolcock Institute of Medical Research
Macquarie Park, New South Wales, Australia
Royal Brisbane and Womens Hospital
Herston, Queensland, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Nucleo de Pesquisa do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil
CaRe Clinic
Calgary, Alberta, Canada
Aggarwal and Associates Ltd
Brampton, Ontario, Canada
Wharton Medical Clinic
Hamilton, Ontario, Canada
Nemocnice Rudolfa a Stefanie Benesov as
Benesov U Prahy, 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
Hospices Civils de Lyon - Centre Hospitalier Lyon Sud
Pierre-Bénite, 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
Erzsebet Gondozohaz
Gödöllő, Hungary
SomnoCenter Szeged Alvaszavar Kozpont
Szeged, Hungary
Reformatus Pulmonologiai Centrum
Törökbálint, Hungary
Saiseikai Futsukaichi Hospital
Chikushino-shi, Fukuoka, Japan
Fukuoka University Hospital
Fukuoka, Fukuoka, Japan
Social Medical Corporation Sokujinkai Sleep and Mental Clinic Kitahiroshima
Kitahiroshima-shi, Hokkaido, Japan
Kuwamizu Hospital
Kumamoto, Kumamoto, Japan
Nakamura Clinic
Urasoe-shi, Okinawa, Japan
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
Warsaw, Poland
Centro Medico Teknon
Barcelona, Catalonia, Spain