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NCT07226765PHASE3Recruiting

Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) Therapy

Amgen

Start Date

11/25/2025

Completion Date

9/13/2028

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 not on PAP therapy and are living with overweight or obesity.

Eligibility Criteria

Age Range: 18 years to 99 years

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 for sleep apnea or major ear, nose, or throat surgery. * Those with significant craniofacial abnormalities that may affect breathing at screening. * Participants diagnosed with Central Apnea with a percentage of central apneas/hypopneas of 50% or more, or those diagnosed with Cheyne Stokes Respiration. * Active device treatment of OSA (eg, PAP, oral appliances), or other treatments, that in the opinion of the investigator, may interfere with study outcomes, unless willing to stop treatment at screening and throughout the study. * 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.

Interventions

DRUG

Maridebart cafraglutide

DRUG

Placebo

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Conditions

Obstructive Sleep Apnea

Locations

Valley Clinical Trials

Northridge, California 91325

United States

Peninsula Research Associates

Rolling Hills Estates, California 90274

United States

Teradan Clinical Trials

Brandon, Florida 33511

United States

Destiny Research Center

Palmetto Bay, Florida 33157

United States

Clinical Research Center Of Florida

Pompano Beach, Florida 33060

United States

NeuroTrials Research

Atlanta, Georgia 30328

United States

Basil Clinical

Laurelton, New York 11413

United States

Monroe Biomedical Research

Monroe, North Carolina 28112

United States

CTI Clinical Research Center

Cincinnati, Ohio 45212

United States

FutureSearch Trials of Neurology

Austin, Texas 78731

United States

Epic Medical Research - DeSoto

DeSoto, Texas 75115

United States

Sleep Therapy & Research Center

San Antonio, Texas 78229

United States

Northwest Clinical Research Center

Bellevue, Washington 98007

United States

Woolcock Institute of Medical Research

Macquarie Park, New South Wales 2113

Australia

Royal Brisbane and Womens Hospital

Herston, Queensland 4006

Australia

Monash Medical Centre

Clayton, Victoria 3168

Australia

Nucleo de Pesquisa do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul 90430-001

Brazil

Instituto de Pesquisa Clinica de Campinas - Ipecc

Campinas, São Paulo 13060-080

Brazil

CPQuali Pesquisa Clinica Ltda

São Paulo, São Paulo 01228-000

Brazil

Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo Hcfmusp

São Paulo, São Paulo 05403-900

Brazil

CaRe Clinic

Calgary, Alberta T2N 4L7

Canada

Aggarwal and Associates Ltd

Brampton, Ontario L6T 0G1

Canada

Wharton Medical Clinic

Hamilton, Ontario L8L 5G8

Canada

Diex Recherche Trois Rivieres

Trois-Rivières, Quebec G9A 4P3

Canada

Nemocnice Rudolfa a Stefanie Benesov as

Benesov U Prahy, 256 01

Czechia

Fakultni nemocnice Brno

Brno, 625 00

Czechia

Cerebrovaskularni poradna sro

Ostrava - Poruba, 708 00

Czechia

Centre Hospitalier Universitaire d'Angers

Angers, 49933

France

Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin

Bordeaux, 33000

France

Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon

Grenoble, 38043

France

Advanced Sleep Research

Berlin, 10117

Germany

InnoDiab Forschung

Essen, 45136

Germany

Diabeteszentrum Hamburg West

Hamburg, 22607

Germany

Siteworks - Zentrum fuer klinische Studien Hannover

Hanover, 30449

Germany

Siteworks - Zentrum fuer klinische Studien Karlsruhe

Karlsruhe, 76137

Germany

Red-Institut GmbH

Oldenburg, 23758

Germany

SomnoCenter Budapest Alvaszavar Kozpont

Budapest, 1012

Hungary

Debreceni Egyetem Klinikai Kozpont

Debrecen, 4032

Hungary

Reformatus Pulmonologiai Centrum

Törökbálint, 2045

Hungary

Saiseikai Futsukaichi Hospital

Chikushino-shi, Fukuoka 818-8516

Japan

Fukuoka University Hospital

Fukuoka, Fukuoka 814-0180

Japan

Mazda Hospital of Mazda Motor Corporation

Aki-gun, Hiroshima 735-8585

Japan

Sleep and Mental Clinic-Kitahiroshima

Kitahiroshima-shi, Hokkaido 061-1121

Japan

RESM ShinYokohama Sleep and Respiratory Medical Care Clinic

Yokohama, Kanagawa 222-0033

Japan

Kuwamizu Hospital

Kumamoto, Kumamoto 862-0954

Japan

Nakamura Clinic

Urasoe-shi, Okinawa 901-2132

Japan

Gokeikai Osaka Kaisei Hospital

Osaka, Osaka 532-0003

Japan

Goodsleep Clinic

Minato-ku, Tokyo 105-0012

Japan

Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy

Warsaw, 04-635

Poland

Centro Medico Teknon

Barcelona, Catalonia 08022

Spain

Hospital Universitari Vall d Hebron

Barcelona, Catalonia 08035

Spain

Hospital Medico Quirurgico San Rafael

A Coruña, Galicia 15006

Spain

Hospital Quiron Madrid

Pozuelo de Alarcón, Madrid 28223

Spain

Hospital Universitario 12 de Octubre

Madrid, 28041

Spain