Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy

Recruiting · NCT07225686 · Interventional (participants receive a specific treatment)

View the official record on ClinicalTrials.gov →

Interventions studied

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 receiving positive airway pressure (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

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 or major ear, nose, or throat surgery for OSA.
Significant craniofacial abnormalities that may affect breathing at screening.
Diagnosis of 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 other than PAP therapy (eg, oral appliances), or other treatments, that in the opinion of the investigator, may interfere with study outcomes.
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.

Where it is running

60 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
Erzsebet Gondozohaz - Gödöllő, Hungary
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
Centre Hospitalier Universitaire de Montpellier - Hôpital Arnaud de Villeneuve - Montpellier, France
Red-Institut GmbH - Oldenburg, Germany
Cerebrovaskularni poradna sro - Ostrava - Poruba, Czechia
Hospices Civils de Lyon - Centre Hospitalier Lyon Sud - Pierre-Bénite, France
Uniwersytecki Szpital Kliniczny w Poznaniu - Poznan, Poland
SomnoCenter Szeged Alvaszavar Kozpont - Szeged, Hungary
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

Showing 60 of 61 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →