Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy (MARITIME-OSA-1)

June 10, 2026 updated by: Amgen

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Macquarie Park, New South Wales, Australia, 2113
        • Recruiting
        • Woolcock Institute of Medical Research
    • Queensland
      • Herston, Queensland, Australia, 4006
        • Recruiting
        • Royal Brisbane and Womens Hospital
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Recruiting
        • Monash Medical Centre
  • Brazil
      • São Paulo, Brazil, 04266-010
        • Recruiting
        • Centro Paulista de Investigacao Clinica Cepic
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-170
        • Recruiting
        • Nucleo de Pesquisa do Rio Grande do Sul
    • São Paulo
      • Campinas, São Paulo, Brazil, 13060-080
        • Recruiting
        • Instituto de Pesquisa Clinica de Campinas - Ipecc
      • São Paulo, São Paulo, Brazil, 01228-000
        • Recruiting
        • CPQuali Pesquisa Clínica Ltda
      • São Paulo, São Paulo, Brazil, 05403-900
        • Recruiting
        • Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo Hcfmusp
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4L7
        • Recruiting
        • CaRe Clinic
    • Ontario
      • Brampton, Ontario, Canada, L6T 0G1
        • Recruiting
        • Aggarwal and Associates Ltd
      • Hamilton, Ontario, Canada, L8L 5G8
        • Recruiting
        • Wharton Medical Clinic
    • Quebec
      • Trois-Rivières, Quebec, Canada, G9A 4P3
        • Recruiting
        • Diex Recherche Trois Rivieres
  • Czechia
      • Benesov U Prahy, Czechia, 256 01
        • Recruiting
        • Nemocnice Rudolfa a Stefanie Benesov as
      • Brno, Czechia, 625 00
        • Recruiting
        • Fakultní nemocnice Brno
      • Ostrava - Poruba, Czechia, 708 00
        • Recruiting
        • Cerebrovaskularni poradna sro
  • France
      • Angers, France, 49933
        • Recruiting
        • Centre Hospitalier Universitaire d'Angers
      • Bordeaux, France, 33000
        • Recruiting
        • Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin
      • Grenoble, France, 38043
        • Recruiting
        • Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon
      • Montpellier, France, 34090
        • Recruiting
        • Centre Hospitalier Universitaire de Montpellier - Hôpital Arnaud de Villeneuve
      • Pierre-Bénite, France, 69495
        • Recruiting
        • Hospices Civils de Lyon - Centre Hospitalier Lyon Sud
  • Germany
      • Berlin, Germany, 10117
        • Recruiting
        • Advanced Sleep Research
      • Essen, Germany, 45136
        • Recruiting
        • InnoDiab Forschung
      • Hamburg, Germany, 22607
        • Recruiting
        • Diabeteszentrum Hamburg West
      • Hanover, Germany, 30449
        • Recruiting
        • Siteworks - Zentrum fuer klinische Studien Hannover
      • Karlsruhe, Germany, 76137
        • Recruiting
        • Siteworks - Zentrum fuer klinische Studien Karlsruhe
      • Oldenburg, Germany, 23758
        • Recruiting
        • Red-Institut GmbH
  • Hungary
      • Budapest, Hungary, 1012
        • Recruiting
        • SomnoCenter Budapest Alvaszavar Kozpont
      • Debrecen, Hungary, 4032
        • Recruiting
        • Debreceni Egyetem Klinikai Kozpont
      • Gödöllő, Hungary, 2100
        • Recruiting
        • Erzsebet Gondozohaz
      • Szeged, Hungary, 6720
        • Recruiting
        • SomnoCenter Szeged Alvaszavar Kozpont
      • Törökbálint, Hungary, 2045
        • Recruiting
        • Reformatus Pulmonologiai Centrum
  • Japan
    • Fukuoka
      • Chikushino-shi, Fukuoka, Japan, 818-8516
        • Recruiting
        • Saiseikai Futsukaichi Hospital
      • Fukuoka, Fukuoka, Japan, 814-0180
        • Recruiting
        • Fukuoka University Hospital
    • Hiroshima
      • Aki-gun, Hiroshima, Japan, 735-8585
        • Recruiting
        • Mazda Hospital of Mazda Motor Corporation
    • Hokkaido
      • Kitahiroshima-shi, Hokkaido, Japan, 061-1121
        • Recruiting
        • Sleep and Mental Clinic-Kitahiroshima
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 222-0033
        • Recruiting
        • RESM ShinYokohama Sleep and Respiratory Medical Care Clinic
    • Kumamoto
      • Kumamoto, Kumamoto, Japan, 862-0954
        • Recruiting
        • Kuwamizu Hospital
    • Okinawa
      • Urasoe-shi, Okinawa, Japan, 901-2132
        • Recruiting
        • Nakamura Clinic
    • Osaka
      • Osaka, Osaka, Japan, 532-0003
        • Recruiting
        • Gokeikai Osaka Kaisei Hospital
    • Tokyo
      • Minato-ku, Tokyo, Japan, 105-0012
        • Recruiting
        • Goodsleep Clinic
  • Poland
      • Bialystok, Poland, 15-276
        • Recruiting
        • Uniwersytecki Szpital Kliniczny w Bialymstoku
      • Warsaw, Poland, 04-635
        • Recruiting
        • Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
  • Spain
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
    • Catalonia
      • Barcelona, Catalonia, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d Hebron
      • Barcelona, Catalonia, Spain, 08022
        • Recruiting
        • Centro Medico Teknon
    • Galicia
      • A Coruña, Galicia, Spain, 15006
        • Recruiting
        • Hospital Medico Quirurgico San Rafael
    • Madrid
      • Pozuelo de Alarcón, Madrid, Spain, 28223
        • Recruiting
        • Hospital Quiron Madrid
  • United States
    • California
      • Northridge, California, United States, 91325
        • Recruiting
        • Valley Clinical Trials
      • Rolling Hills Estates, California, United States, 90274
        • Recruiting
        • Peninsula Research Associates
    • Florida
      • Brandon, Florida, United States, 33511
        • Recruiting
        • Teradan Clinical Trials
      • Palmetto Bay, Florida, United States, 33157
        • Recruiting
        • Destiny Research Center
      • Pompano Beach, Florida, United States, 33060
        • Recruiting
        • Clinical Research Center Of Florida
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Recruiting
        • NeuroTrials Research
    • New York
      • Laurelton, New York, United States, 11413
        • Recruiting
        • Basil Clinical
    • North Carolina
      • Monroe, North Carolina, United States, 28112
        • Recruiting
        • Monroe Biomedical Research
    • Ohio
      • Cincinnati, Ohio, United States, 45212
        • Recruiting
        • CTI Clinical Research Center
    • Texas
      • Austin, Texas, United States, 78731
        • Recruiting
        • FutureSearch Trials of Neurology
      • DeSoto, Texas, United States, 75115
        • Recruiting
        • Epic Medical Research - DeSoto
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Sleep Therapy & Research Center
    • Washington
      • Bellevue, Washington, United States, 98007
        • Recruiting
        • Northwest Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 for sleep apnea or major ear, nose, or throat surgery.
  • Significant craniofacial abnormalities that may affect breathing at screening.
  • Diagnosis of Central Apnea with % of central apneas/hypopneas ≥ 50%, and/or diagnosis of Cheyne Stokes Respiration.
  • Active device treatment of obstructive sleep apnea other than PAP therapy (eg, oral appliances), or other treatments, that in the opinion of the investigator, may interfere with trial outcomes, unless willing to stop treatment at screening and throughout the trial.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants will receive placebo SC.
Drug: Placebo
Participants will receive placebo SC.
Experimental: Maridebart Cafraglutide
Participants will receive maridebart cafraglutide subcutaneously (SC).
Drug: Maridebart cafraglutide
Participants will receive maridebart cafraglutide as SC injections.
Other Names:
  • AMG 133

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in AHI from baseline at week 52
Time Frame: At Week 52
At Week 52

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Sleep Apnea-specific Hypoxic Burden (SASHB) from baseline at Week 52
Time Frame: At Week 52
At Week 52
Change in High Sensitivity C-reactive Protein (hs-CRP) from baseline at Week 52
Time Frame: At Week 52
At Week 52
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Sleep-related Impairment 8a Score from baseline at Week 52
Time Frame: At Week 52
At Week 52
Percentage Change in AHI from baseline at week 52
Time Frame: At Week 52
At Week 52
Participants Achieving ≥ 50% AHI Reduction from baseline at week 52
Time Frame: At Week 52
At Week 52
Participants Achieving AHI < 5 or AHI 5 to 14 with Epworth Sleepiness Scale (ESS) ≤ 10 from baseline at week 52
Time Frame: At Week 52
At Week 52
Percentage Change in Body Weight from baseline at Week 52
Time Frame: At Week 52
At Week 52
Change in Systolic Blood Pressure from baseline at Week 48
Time Frame: At Week 48
At Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Investigators

  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2025

Primary Completion (Estimated)

September 29, 2027

Study Completion (Estimated)

September 13, 2028

Study Registration Dates

First Submitted

November 5, 2025

First Submitted That Met QC Criteria

November 5, 2025

First Posted (Actual)

November 10, 2025

Study Record Updates

Last Update Posted (Actual)

June 12, 2026

Last Update Submitted That Met QC Criteria

June 10, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20230225

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

IPD Sharing Time Frame

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

IPD Sharing Access Criteria

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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