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

Last updated: May 13, 2026
Sponsor: Amgen
Overall Status: Active - Recruiting

Phase

3

Condition

Sleep Apnea Syndromes

Obesity

Diabetes Prevention

Treatment

Placebo

Maridebart cafraglutide

Clinical Study ID

NCT07226765
20250002
  • Ages 18-99
  • All Genders

Study 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

Inclusion

Inclusion Criteria:

  • Participants must have an AHI of 15 or higher on polysomnography (PSG) at Day 1before 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 andexercise.

  • 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 thestudy.

Exclusion

Exclusion Criteria:

  • Individuals who have had any previous or planned upper airway surgery for sleepapnea or major ear, nose, or throat surgery.

  • Those with significant craniofacial abnormalities that may affect breathing atscreening.

  • Participants diagnosed with Central Apnea with a percentage of centralapneas/hypopneas of 50% or more, or those diagnosed with Cheyne Stokes Respiration.

  • Active device treatment of OSA (eg, PAP, oral appliances), or other treatments, thatin the opinion of the investigator, may interfere with study outcomes, unlesswilling to stop treatment at screening and throughout the study.

  • Individuals with respiratory diseases like obesity hypoventilation syndrome ordaytime hypercapnia, neuromuscular diseases or other conditions that could interferewith the trial results, according to the investigator's opinion.

Study Design

Total Participants: 250
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
November 25, 2025
Estimated Completion Date:
September 13, 2028

Connect with a study center

  • Woolcock Institute of Medical Research

    Macquarie Park, New South Wales 2113
    Australia

    Active - Recruiting

  • Woolcock Institute of Medical Research

    Macquarie Park 8347858, New South Wales 2155400 2113
    Australia

    Site Not Available

  • Royal Brisbane and Womens Hospital

    Herston, Queensland 4006
    Australia

    Active - Recruiting

  • Royal Brisbane and Womens Hospital

    Herston 6931014, Queensland 2152274 4006
    Australia

    Site Not Available

  • Monash Medical Centre

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Nucleo de Pesquisa do Rio Grande do Sul

    Porto Alegre, Rio Grande do Sul 90430-001
    Brazil

    Active - Recruiting

  • CPQuali Pesquisa Clinica Ltda

    São Paulo, São Paulo 01228-000
    Brazil

    Active - Recruiting

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

    São Paulo, São Paulo 05403-900
    Brazil

    Active - Recruiting

  • CaRe Clinic

    Calgary, Alberta T2N 4L7
    Canada

    Active - Recruiting

  • CaRe Clinic

    Calgary 5913490, Alberta 5883102 T2N 4L7
    Canada

    Site Not Available

  • Aggarwal and Associates Ltd

    Brampton, Ontario L6T 0G1
    Canada

    Active - Recruiting

  • Wharton Medical Clinic

    Hamilton, Ontario L8L 5G8
    Canada

    Active - Recruiting

  • Aggarwal and Associates Ltd

    Brampton 5907364, Ontario 6093943 L6T 0G1
    Canada

    Site Not Available

  • Wharton Medical Clinic

    Hamilton 5969782, Ontario 6093943 L8L 5G8
    Canada

    Site Not Available

  • Nemocnice Rudolfa a Stefanie Benesov as

    Benesov U Prahy, 256 01
    Czechia

    Active - Recruiting

  • Fakultni nemocnice Brno

    Brno, 625 00
    Czechia

    Active - Recruiting

  • Cerebrovaskularni poradna sro

    Ostrava - Poruba, 708 00
    Czechia

    Active - Recruiting

  • Advanced Sleep Research

    Berlin, 10117
    Germany

    Active - Recruiting

  • InnoDiab Forschung

    Essen, 45136
    Germany

    Active - Recruiting

  • Diabeteszentrum Hamburg West

    Hamburg, 22607
    Germany

    Active - Recruiting

  • Diabeteszentrum Hamburg West

    Hamburg 2911298, 22607
    Germany

    Site Not Available

  • Siteworks - Zentrum fuer klinische Studien Hannover

    Hanover, 30449
    Germany

    Active - Recruiting

  • Siteworks - Zentrum fuer klinische Studien Hannover

    Hanover 2910831, 30449
    Germany

    Site Not Available

  • Siteworks - Zentrum fuer klinische Studien Karlsruhe

    Karlsruhe, 76137
    Germany

    Active - Recruiting

  • Siteworks - Zentrum fuer klinische Studien Karlsruhe

    Karlsruhe 2892794, 76137
    Germany

    Site Not Available

  • Red-Institut GmbH

    Oldenburg, 23758
    Germany

    Active - Recruiting

  • Red-Institut GmbH

    Oldenburg 2857458, 23758
    Germany

    Site Not Available

  • SomnoCenter Budapest Alvaszavar Kozpont

    Budapest, 1012
    Hungary

    Active - Recruiting

  • Reformatus Pulmonologiai Centrum

    Törökbálint, 2045
    Hungary

    Active - Recruiting

  • Saiseikai Futsukaichi Hospital

    Chikushino-shi, Fukuoka 818-8516
    Japan

    Active - Recruiting

  • Fukuoka University Hospital

    Fukuoka, Fukuoka 814-0180
    Japan

    Active - Recruiting

  • Fukuoka University Hospital

    Fukuoka 1863967, Fukuoka 1863958 814-0180
    Japan

    Site Not Available

  • Sleep and Mental Clinic-Kitahiroshima

    Kitahiroshima-shi, Hokkaido 061-1121
    Japan

    Active - Recruiting

  • Social Medical Corporation Sokujinkai Sleep and Mental Clinic Kitahiroshima

    Kitahiroshima-shi, Hokkaido 061-1121
    Japan

    Active - Recruiting

  • RESM ShinYokohama Sleep and Respiratory Medical Care Clinic

    Yokohama, Kanagawa 222-0033
    Japan

    Active - Recruiting

  • Kuwamizu Hospital

    Kumamoto, Kumamoto 862-0954
    Japan

    Active - Recruiting

  • Nakamura Clinic

    Urasoe-shi, Okinawa 901-2132
    Japan

    Active - Recruiting

  • Gokeikai Osaka Kaisei Hospital

    Osaka, Osaka 532-0003
    Japan

    Active - Recruiting

  • Goodsleep Clinic

    Minato-ku, Tokyo 105-0012
    Japan

    Active - Recruiting

  • Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy

    Warsaw, 04-635
    Poland

    Active - Recruiting

  • Centro Medico Teknon

    Barcelona, Catalonia 08022
    Spain

    Active - Recruiting

  • Hospital Universitari Vall d Hebron

    Barcelona, Catalonia 08035
    Spain

    Active - Recruiting

  • Hospital Medico Quirurgico San Rafael

    A Coruña, Galicia 15006
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Valley Clinical Trials

    Northridge, California 91325
    United States

    Active - Recruiting

  • Peninsula Research Associates

    Rolling Hills Estates, California 90274
    United States

    Active - Recruiting

  • Peninsula Research Associates

    Rolling Hills Estates 5388601, California 5332921 90274
    United States

    Site Not Available

  • Teradan Clinical Trials

    Brandon, Florida 33511
    United States

    Active - Recruiting

  • Destiny Research Center

    Palmetto Bay, Florida 33157
    United States

    Active - Recruiting

  • Clinical Research Center Of Florida

    Pompano Beach, Florida 33060
    United States

    Active - Recruiting

  • Teradan Clinical Trials

    Brandon 4148757, Florida 4155751 33511
    United States

    Site Not Available

  • Destiny Research Center

    Palmetto Bay 4167634, Florida 4155751 33157
    United States

    Site Not Available

  • Clinical Research Center Of Florida

    Pompano Beach 4169014, Florida 4155751 33060
    United States

    Site Not Available

  • NeuroTrials Research

    Atlanta, Georgia 30328
    United States

    Active - Recruiting

  • Basil Clinical

    Laurelton, New York 11413
    United States

    Active - Recruiting

  • Basil Clinical

    Laurelton 5124078, New York 5128638 11413
    United States

    Site Not Available

  • Monroe Biomedical Research

    Monroe, North Carolina 28112
    United States

    Active - Recruiting

  • Monroe Biomedical Research

    Monroe 4479946, North Carolina 4482348 28112
    United States

    Site Not Available

  • CTI Clinical Research Center

    Cincinnati, Ohio 45212
    United States

    Active - Recruiting

  • CTI Clinical Research Center

    Cincinnati 4508722, Ohio 5165418 45212
    United States

    Site Not Available

  • FutureSearch Trials of Neurology

    Austin, Texas 78731
    United States

    Active - Recruiting

  • Epic Medical Research - DeSoto

    DeSoto, Texas 75115
    United States

    Active - Recruiting

  • Sleep Therapy & Research Center

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • FutureSearch Trials of Neurology

    Austin 4671654, Texas 4736286 78731
    United States

    Site Not Available

  • Epic Medical Research - DeSoto

    DeSoto 4685524, Texas 4736286 75115
    United States

    Site Not Available

  • Sleep Therapy & Research Center

    San Antonio 4726206, Texas 4736286 78229
    United States

    Site Not Available

  • Northwest Clinical Research Center

    Bellevue, Washington 98007
    United States

    Active - Recruiting

  • Northwest Clinical Research Center

    Bellevue 5786882, Washington 5815135 98007
    United States

    Site Not Available

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