RecruitingPhase 3NCT07225686

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

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

Sponsor

Amgen

Enrollment

250 participants

Start Date

Dec 19, 2025

Study Type

INTERVENTIONAL

Conditions

Obesity Obstructive Sleep Apnea

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.

Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Maridebart cafraglutide and a drug called Placebo for people with obesity and obstructive sleep apnea. The study is currently recruiting participants at 56 locations. People eligible for this study include aged 18 Years to 99 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMaridebart cafraglutide

Participants will receive maridebart cafraglutide as SC injections.

DRUGPlacebo

Participants will receive placebo SC.

Locations(60)

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

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

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

Centro Paulista de Investigacao Clinica Cepic

São Paulo, Brazil

CaRe Clinic

Calgary, Alberta, Canada

Aggarwal and Associates Ltd

Brampton, Ontario, 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

Saiseikai Futsukaichi Hospital

Chikushino-shi, Fukuoka, Japan

Fukuoka University Hospital

Fukuoka, Fukuoka, Japan

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

Nakamura Clinic

Urasoe-shi, Okinawa, Japan

Gokeikai Osaka Kaisei Hospital

Osaka, Osaka, Japan

Goodsleep Clinic

Minato-ku, Tokyo, Japan

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, Poland

Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy

Warsaw, Poland

Centro Medico Teknon

Barcelona, Catalonia, Spain

Hospital Universitari Vall d Hebron

Barcelona, Catalonia, Spain

Hospital Medico Quirurgico San Rafael

A Coruña, Galicia, Spain

Hospital Quiron Madrid

Pozuelo de Alarcón, Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

View Full Details on ClinicalTrials.gov

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NCT07225686

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