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

August 3, 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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
        • Fakultni 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
      • Poznan, Poland, 60-569
        • Recruiting
        • Uniwersytecki Szpital Kliniczny w Poznaniu
      • 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 Médico 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 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.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in Apnea-Hypopnea Index (AHI) from baseline at week 52
Time Frame: At week 52
At week 52

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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 Sleep Apnea-specific Hypoxic Burden (SASHB) from baseline at week 52
Time Frame: At week 52
At week 52
Percentage change in High Sensitivity C-reactive Protein (hs-CRP) 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
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
Change in AHI from baseline at week 24
Time Frame: At week 24
At week 24
Percentage change in AHI from baseline at week 24
Time Frame: At week 24
At week 24
Change in SASHB from baseline at week 24
Time Frame: At week 24
At week 24
Change in ESS score from baseline at week 52
Time Frame: At week 52
At week 52
Change in PROMIS Short Form v1.0 Sleep Disturbance 8b score from baseline at week 52
Time Frame: At week 52
At week 52
Change in Short Form-36 Health Survey Version 2 (SF-36v2) Acute domain and summary scores from baseline at week 52
Time Frame: At week 52
At week 52
Change from baseline at week 52 in Patient Global Impression of Severity (PGI-S) Sleep-related impairment, Sleep quality, and Sleepiness.
Time Frame: At week 52
At week 52
Percentage of participants achieving ≥ 10% reduction in body weight from baseline at week 52
Time Frame: At week 52
At week 52
Percentage of participants achieving ≥ 15% reduction in body weight from baseline at week 52
Time Frame: At week 52
At week 52
Percentage of participants achieving ≥ 20% reduction in body weight from baseline at week 52
Time Frame: At week 52
At week 52
Change in waist circumference from baseline at week 52
Time Frame: At week 52
At week 52
Change in waist-to-height ratio from baseline at week 52
Time Frame: At week 52
At week 52
Change in neck circumference from baseline at week 52
Time Frame: At week 52
At week 52
Percentage change in Total Cholesterol, High-density lipoprotein cholesterol (HDL-C), Non-HDL-C, Low-density lipoprotein cholesterol (LDL-C), and Triglycerides from baseline at week 52 in fasting conditions
Time Frame: At week 52
At week 52
Percent change from baseline at week 52 in fasting insulin
Time Frame: At week 52
At week 52
Change from baseline at week 52 in fasting plasma glucose (FPG) (mg/dL, mmol/L)
Time Frame: At week 52
At week 52
Change in hemoglobin A1c (HbA1c) (%, mmol/mol) from baseline at week 52
Time Frame: At week 52
At week 52
Change in Diastolic Blood Pressure (DBP) from baseline at week 48
Time Frame: At week 48
At week 48
Number of participants with Treatment-Emergent Adverse Events and Serious Adverse Events
Time Frame: Up to 100 weeks
Up to 100 weeks
Plasma concentration of maridebart cafraglutide at week 52
Time Frame: At week 52
At week 52

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amgen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 19, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 29, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 13, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 5, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 10, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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