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NCT07225686Active, not recruitingPhase 3

Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy

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

Source: ClinicalTrials.gov · Last updated 6 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
250 (estimated)
First submitted
5 Nov 2025
Start date
19 Dec 2025
Primary completion date
20 Aug 2027
Lead sponsor
Amgen
Diseases
Obesity
NCT number
NCT07225686

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 250
  • From 19 Dec 2025 to the primary completion date, 20 Aug 2027
  • 61 sites in 11 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Had any previous or planned upper airway surgery or major ear, nose, or throat surgery for OSA.
  • 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.

Other illness

  • 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.

Other

  • 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.
  • Have personal circumstances or job-related responsibilities that prevent a 7-day PAP withdrawal before polysomnography testing during the course of the trial.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (61)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Monash Medical Centre
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ClaytonAustraliaUnknown status
Royal Brisbane and Womens Hospital
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HerstonAustraliaUnknown status
Woolcock Institute of Medical Research
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Macquarie ParkAustraliaUnknown status
Instituto De Pesquisa Clinica de Campinas (Ipecc)
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CampinasBrazilUnknown status
Núcleo de Pesquisa do Rio Grande do Sul
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Porto AlegreBrazilUnknown status
Centro Paulista de Investigacao Clinica Cepic
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São PauloBrazilUnknown status
CPQuali Pesquisa Clínica Ltda
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São PauloBrazilUnknown status
Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo Hcfmusp
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São PauloBrazilUnknown status
Aggarwal and Associates Ltd
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BramptonCanadaUnknown status
CaRe Clinic
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CalgaryCanadaUnknown status
Wharton Medical Clinic
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HamiltonCanadaUnknown status
Diex Recherche Trois-Rivieres
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Trois-RivièresCanadaUnknown status
Nemocnice Rudolfa a Stefanie Benesov as
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Benesov U PrahyCzechiaUnknown status
Fakultni nemocnice Brno
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BrnoCzechiaUnknown status
Cerebrovaskularni poradna sro
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Ostrava - PorubaCzechiaUnknown status
Advanced Sleep Research
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BerlinGermanyUnknown status
InnoDiab Forschung
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EssenGermanyUnknown status
Diabeteszentrum Hamburg West
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HamburgGermanyUnknown status
Siteworks - Zentrum fuer klinische Studien Hannover
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HanoverGermanyUnknown status
Siteworks - Zentrum fuer klinische Studien Karlsruhe
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KarlsruheGermanyUnknown status
RED-Institut GmbH
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OldenburgGermanyUnknown status
Hospital Medico Quirurgico San Rafael
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A CoruñaSpainUnknown status
Centro Médico Teknon
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BarcelonaSpainUnknown status
Hospital Universitari Vall d'Hebron
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BarcelonaSpainUnknown status
Hospital Universitario 12 de Octubre
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MadridSpainUnknown status
Hospital Quirón Madrid
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Pozuelo de AlarcónSpainUnknown status
Centre Hospitalier Universitaire D'Angers
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AngersFranceUnknown status
Centre Hospitalier Universitaire de Bordeaux Hopital Pellegrin
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BordeauxFranceUnknown status
Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon
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GrenobleFranceUnknown status
Centre Hospitalier Universitaire de Montpellier - Hopital Arnaud de Villeneuve
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MontpellierFranceUnknown status
Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud
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Pierre-BéniteFranceUnknown status
SomnoCenter Budapest Alvaszavar Kozpont
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BudapestHungaryUnknown status
Debreceni Egyetem Klinikai Kozpont
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DebrecenHungaryUnknown status
Erzsebet Gondozohaz
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GödöllőHungaryUnknown status
SomnoCenter Szeged Alvaszavar Kozpont
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SzegedHungaryUnknown status
Református Pulmonológiai Centrum
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TörökbálintHungaryUnknown status
Mazda Hospital of Mazda Motor Corporation
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Aki-gunJapanUnknown status
Saiseikai Futsukaichi Hospital
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Chikushino-shiJapanUnknown status
Fukuoka University Hospital
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FukuokaJapanUnknown status
Sleep and Mental Clinic-Kitahiroshima
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Kitahiroshima-shiJapanUnknown status
Kuwamizu Hospital
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KumamotoJapanUnknown status
Goodsleep Clinic
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Minato-kuJapanUnknown status
Gokeikai Osaka Kaisei Hospital
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OsakaJapanUnknown status
Nakamura Clinic
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Urasoe-shiJapanUnknown status
RESM ShinYokohama Sleep and Respiratory Medical Care Clinic
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YokohamaJapanUnknown status
Uniwersytecki Szpital Kliniczny w Bialymstoku
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BialystokPolandUnknown status
Uniwersytecki Szpital Kliniczny w Poznaniu
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PoznanPolandUnknown status
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
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WarsawPolandUnknown status
NeuroTrials Research
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AtlantaUnited StatesUnknown status
FutureSearch Trials of Neurology
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AustinUnited StatesUnknown status
Northwest Clinical Research Center
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BellevueUnited StatesUnknown status
Teradan Clinical Trials
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BrandonUnited StatesUnknown status
CTI Clinical Research Center
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CincinnatiUnited StatesUnknown status
Epic Medical Research - DeSoto
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DeSotoUnited StatesUnknown status
Basil Clinical
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LaureltonUnited StatesUnknown status
Monroe Biomedical Research
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MonroeUnited StatesUnknown status
Valley Clinical Trials
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NorthridgeUnited StatesUnknown status
Destiny Research Center
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Palmetto BayUnited StatesUnknown status
Clinical Research Center of Florida
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Pompano BeachUnited StatesUnknown status
Peninsula Research Associates
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Rolling Hills EstatesUnited StatesUnknown status
Sleep Therapy Research Center
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San AntonioUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.