Clinical trial

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

Recruiting now · Phase 3 · 8 countries · Registry ID NCT07225686

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 receiving positive airway pressure (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
ConditionObesity, Obstructive Sleep Apnea

Full registry criteria

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.

Treatments and study arms

Maridebart cafraglutide

Drug

Participants will receive maridebart cafraglutide as SC injections.

Placebo

Drug

Participants will receive placebo SC.

Primary outcomes

Change in Apnea-Hypopnea Index (AHI) from baseline at week 52At week 52

Study locations

61 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
Centre Hospitalier Universitaire de Montpellier - Hôpital Arnaud de Villeneuve🇫🇷 Montpellier, 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
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