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New drug could ease sleep apnea and help shed pounds

NCT ID NCT07225686

Disease control Sponsor: Amgen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 3 times

Summary

This study tests a new medicine, maridebart cafraglutide, for adults with obstructive sleep apnea who are overweight or obese and already use a CPAP machine. The goal is to see if the drug can reduce breathing pauses during sleep and help with weight loss over 52 weeks. About 250 participants will receive either the drug or a placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder obstructive sleep apnea syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obesity Obstructive sleep apnea

Contacts and locations

Locations

  • Advanced Sleep Research

    Berlin, 10117, Germany

  • Aggarwal and Associates Ltd

    Brampton, Ontario, L6T 0G1, Canada

  • Basil Clinical

    Laurelton, New York, 11413, United States

  • CPQuali Pesquisa Clinica Ltda

    São Paulo, São Paulo, 01228-000, Brazil

  • CTI Clinical Research Center

    Cincinnati, Ohio, 45212, United States

  • CaRe Clinic

    Calgary, Alberta, T2N 4L7, Canada

  • 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

  • Centre Hospitalier Universitaire de Montpellier - Hôpital Arnaud de Villeneuve

    Montpellier, 34090, France

  • Centro Medico Teknon

    Barcelona, Catalonia, 08022, Spain

  • Centro Paulista de Investigacao Clinica Cepic

    São Paulo, 04266-010, Brazil

  • Cerebrovaskularni poradna sro

    Ostrava - Poruba, 708 00, Czechia

  • Clinical Research Center Of Florida

    Pompano Beach, Florida, 33060, United States

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032, Hungary

  • Destiny Research Center

    Palmetto Bay, Florida, 33157, United States

  • Diabeteszentrum Hamburg West

    Hamburg, 22607, Germany

  • Diex Recherche Trois Rivieres

    Trois-Rivières, Quebec, G9A 4P3, Canada

  • Epic Medical Research - DeSoto

    DeSoto, Texas, 75115, United States

  • Erzsebet Gondozohaz

    Gödöllő, 2100, Hungary

  • Fakultni nemocnice Brno

    Brno, 625 00, Czechia

  • Fukuoka University Hospital

    Fukuoka, Fukuoka, 814-0180, Japan

  • FutureSearch Trials of Neurology

    Austin, Texas, 78731, United States

  • Gokeikai Osaka Kaisei Hospital

    Osaka, Osaka, 532-0003, Japan

  • Goodsleep Clinic

    Minato-ku, Tokyo, 105-0012, Japan

  • Hospices Civils de Lyon - Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495, France

  • Hospital Medico Quirurgico San Rafael

    A Coruña, Galicia, 15006, Spain

  • Hospital Quiron Madrid

    Pozuelo de Alarcón, Madrid, 28223, Spain

  • Hospital Universitari Vall d Hebron

    Barcelona, Catalonia, 08035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

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

    São Paulo, São Paulo, 05403-900, Brazil

  • InnoDiab Forschung

    Essen, 45136, Germany

  • Instituto de Pesquisa Clinica de Campinas - Ipecc

    Campinas, São Paulo, 13060-080, Brazil

  • Kuwamizu Hospital

    Kumamoto, Kumamoto, 862-0954, Japan

  • Mazda Hospital of Mazda Motor Corporation

    Aki-gun, Hiroshima, 735-8585, Japan

  • Monash Medical Centre

    Clayton, Victoria, 3168, Australia

  • Monroe Biomedical Research

    Monroe, North Carolina, 28112, United States

  • Nakamura Clinic

    Urasoe-shi, Okinawa, 901-2132, Japan

  • Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy

    Warsaw, 04-635, Poland

  • Nemocnice Rudolfa a Stefanie Benesov as

    Benesov U Prahy, 256 01, Czechia

  • NeuroTrials Research

    Atlanta, Georgia, 30328, United States

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007, United States

  • Nucleo de Pesquisa do Rio Grande do Sul

    Porto Alegre, Rio Grande do Sul, 90035-170, Brazil

  • Peninsula Research Associates

    Rolling Hills Estates, California, 90274, United States

  • RESM ShinYokohama Sleep and Respiratory Medical Care Clinic

    Yokohama, Kanagawa, 222-0033, Japan

  • Red-Institut GmbH

    Oldenburg, 23758, Germany

  • Reformatus Pulmonologiai Centrum

    Törökbálint, 2045, Hungary

  • Royal Brisbane and Womens Hospital

    Herston, Queensland, 4006, Australia

  • Saiseikai Futsukaichi Hospital

    Chikushino-shi, Fukuoka, 818-8516, Japan

  • Siteworks - Zentrum fuer klinische Studien Hannover

    Hanover, 30449, Germany

  • Siteworks - Zentrum fuer klinische Studien Karlsruhe

    Karlsruhe, 76137, Germany

  • Sleep Therapy & Research Center

    San Antonio, Texas, 78229, United States

  • Sleep and Mental Clinic-Kitahiroshima

    Kitahiroshima-shi, Hokkaido, 061-1121, Japan

  • SomnoCenter Budapest Alvaszavar Kozpont

    Budapest, 1012, Hungary

  • SomnoCenter Szeged Alvaszavar Kozpont

    Szeged, 6720, Hungary

  • Teradan Clinical Trials

    Brandon, Florida, 33511, United States

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, 15-276, Poland

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Poznan, 60-569, Poland

  • Valley Clinical Trials

    Northridge, California, 91325, United States

  • Wharton Medical Clinic

    Hamilton, Ontario, L8L 5G8, Canada

  • Woolcock Institute of Medical Research

    Macquarie Park, New South Wales, 2113, Australia

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Other studies related to the condition(s) this trial covers.