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NCT07226765Active, not recruitingPhase 3

Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) 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 Not on Positive Airway Pressure Therapy and Living With Overweight or Obesity (MARITIME-OSA-2)

Source: ClinicalTrials.gov · Last updated 29 Sept 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 not on 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
6 Nov 2025
Start date
Nov 2025
Primary completion date
Aug 2027
Lead sponsor
Amgen
Diseases
Obesity
NCT number
NCT07226765

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 250
  • From Nov 2025 to the primary completion date, Aug 2027
  • 57 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

  • Individuals who have had any previous or planned upper airway surgery or major ear, nose or throat surgery for OSA.

Other illness

  • 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.

Other

  • 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.

Who the study is looking for

  • 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.

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

Full criteria on ClinicalTrials.gov

Sites (57)

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
Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo Hcfmusp
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São PauloBrazilUnknown status
CPQuali Pesquisa Clínica Ltda
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São PauloBrazilUnknown status
Centro Paulista de Investigacao Clinica Cepic
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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
SomnoCenter Budapest Alvaszavar Kozpont
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BudapestHungaryUnknown status
Debreceni Egyetem Klinikai Kozpont
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DebrecenHungaryUnknown 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.