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Could a Weight-Loss drug cure sleep apnea without a machine?

NCT ID NCT07226765

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 14, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether maridebart cafraglutide, a drug that may help with weight loss, can reduce sleep apnea episodes in 250 adults who are overweight or obese and not using a breathing machine. Participants receive either the drug or a placebo for 52 weeks. The main goal is to see if the drug lowers the number of breathing pauses during sleep.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
maridebart cafraglutide (also called AMG 133 or MariTide)
What this could lead to
If it works, this could offer a new drug treatment for sleep apnea that also helps with weight loss, reducing the need for breathing machines.
What could go wrong
This is still a clinical trial, so the drug may not work better than placebo. Side effects are possible, and results may not apply to everyone with sleep apnea.

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

Nov 2025

Expected to finish

Sep 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: * 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 or major ear, nose or throat surgery for OSA. * Those with significant craniofacial abnormalities that may affect breathing at screening. * Participants diagnosed with 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 or other treatments, that in the opinion of the investigator, may interfere with study outcomes. * 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.

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Conditions

The condition(s) this trial relates to.

Obesity obstructive sleep apnea syndrome Overweight

As listed by the trial registrant

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

Obstructive sleep apnea

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    57 sites in 11 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Advanced Sleep Research

    RECRUITING

    Berlin, 10117, Germany

  • Aggarwal and Associates Ltd

    RECRUITING

    Brampton, Ontario, L6T 0G1, Canada

  • Basil Clinical

    RECRUITING

    Laurelton, New York, 11413, United States

  • CPQuali Pesquisa Clinica Ltda

    RECRUITING

    São Paulo, São Paulo, 01228-000, Brazil

  • CTI Clinical Research Center

    RECRUITING

    Cincinnati, Ohio, 45212, United States

  • CaRe Clinic

    RECRUITING

    Calgary, Alberta, T2N 4L7, Canada

  • Centre Hospitalier Universitaire d'Angers

    RECRUITING

    Angers, 49933, France

  • Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin

    RECRUITING

    Bordeaux, 33000, France

  • Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon

    RECRUITING

    Grenoble, 38043, France

  • Centro Medico Teknon

    RECRUITING

    Barcelona, Catalonia, 08022, Spain

  • Centro Paulista de Investigacao Clinica Cepic

    RECRUITING

    São Paulo, 04266-010, Brazil

  • Cerebrovaskularni poradna sro

    RECRUITING

    Ostrava - Poruba, 708 00, Czechia

  • Clinical Research Center Of Florida

    RECRUITING

    Pompano Beach, Florida, 33060, United States

  • Debreceni Egyetem Klinikai Kozpont

    RECRUITING

    Debrecen, 4032, Hungary

  • Destiny Research Center

    RECRUITING

    Palmetto Bay, Florida, 33157, United States

  • Diabeteszentrum Hamburg West

    RECRUITING

    Hamburg, 22607, Germany

  • Diex Recherche Trois Rivieres

    RECRUITING

    Trois-Rivières, Quebec, G9A 4P3, Canada

  • Epic Medical Research - DeSoto

    RECRUITING

    DeSoto, Texas, 75115, United States

  • Fakultni nemocnice Brno

    RECRUITING

    Brno, 625 00, Czechia

  • Fukuoka University Hospital

    RECRUITING

    Fukuoka, Fukuoka, 814-0180, Japan

  • FutureSearch Trials of Neurology

    RECRUITING

    Austin, Texas, 78731, United States

  • Gokeikai Osaka Kaisei Hospital

    RECRUITING

    Osaka, Osaka, 532-0003, Japan

  • Goodsleep Clinic

    RECRUITING

    Minato-ku, Tokyo, 105-0012, Japan

  • Hospital Medico Quirurgico San Rafael

    RECRUITING

    A Coruña, Galicia, 15006, Spain

  • Hospital Quiron Madrid

    RECRUITING

    Pozuelo de Alarcón, Madrid, 28223, Spain

  • Hospital Universitari Vall d Hebron

    RECRUITING

    Barcelona, Catalonia, 08035, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

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

    RECRUITING

    São Paulo, São Paulo, 05403-900, Brazil

  • InnoDiab Forschung

    RECRUITING

    Essen, 45136, Germany

  • Instituto de Pesquisa Clinica de Campinas - Ipecc

    RECRUITING

    Campinas, São Paulo, 13060-080, Brazil

  • Kuwamizu Hospital

    RECRUITING

    Kumamoto, Kumamoto, 862-0954, Japan

  • Mazda Hospital of Mazda Motor Corporation

    RECRUITING

    Aki-gun, Hiroshima, 735-8585, Japan

  • Monash Medical Centre

    RECRUITING

    Clayton, Victoria, 3168, Australia

  • Monroe Biomedical Research

    RECRUITING

    Monroe, North Carolina, 28112, United States

  • Nakamura Clinic

    RECRUITING

    Urasoe-shi, Okinawa, 901-2132, Japan

  • Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy

    RECRUITING

    Warsaw, 04-635, Poland

  • Nemocnice Rudolfa a Stefanie Benesov as

    RECRUITING

    Benesov U Prahy, 256 01, Czechia

  • NeuroTrials Research

    RECRUITING

    Atlanta, Georgia, 30328, United States

  • Northwest Clinical Research Center

    RECRUITING

    Bellevue, Washington, 98007, United States

  • Nucleo de Pesquisa do Rio Grande do Sul

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 90430-001, Brazil

  • Peninsula Research Associates

    RECRUITING

    Rolling Hills Estates, California, 90274, United States

  • RESM ShinYokohama Sleep and Respiratory Medical Care Clinic

    RECRUITING

    Yokohama, Kanagawa, 222-0033, Japan

  • Red-Institut GmbH

    RECRUITING

    Oldenburg, 23758, Germany

  • Reformatus Pulmonologiai Centrum

    RECRUITING

    Törökbálint, 2045, Hungary

  • Royal Brisbane and Womens Hospital

    RECRUITING

    Herston, Queensland, 4006, Australia

  • Saiseikai Futsukaichi Hospital

    RECRUITING

    Chikushino-shi, Fukuoka, 818-8516, Japan

  • Siteworks - Zentrum fuer klinische Studien Hannover

    RECRUITING

    Hanover, 30449, Germany

  • Siteworks - Zentrum fuer klinische Studien Karlsruhe

    RECRUITING

    Karlsruhe, 76137, Germany

  • Sleep Therapy & Research Center

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Sleep and Mental Clinic-Kitahiroshima

    RECRUITING

    Kitahiroshima-shi, Hokkaido, 061-1121, Japan

  • SomnoCenter Budapest Alvaszavar Kozpont

    RECRUITING

    Budapest, 1012, Hungary

  • Teradan Clinical Trials

    RECRUITING

    Brandon, Florida, 33511, United States

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    RECRUITING

    Bialystok, 15-276, Poland

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    RECRUITING

    Poznan, 60-569, Poland

  • Valley Clinical Trials

    RECRUITING

    Northridge, California, 91325, United States

  • Wharton Medical Clinic

    RECRUITING

    Hamilton, Ontario, L8L 5G8, Canada

  • Woolcock Institute of Medical Research

    RECRUITING

    Macquarie Park, New South Wales, 2113, Australia

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