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
Sites (61)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Monash Medical Centre Coordinator of this site? Confirm its status | Clayton | Australia | Unknown status |
| Royal Brisbane and Womens Hospital Coordinator of this site? Confirm its status | Herston | Australia | Unknown status |
| Woolcock Institute of Medical Research Coordinator of this site? Confirm its status | Macquarie Park | Australia | Unknown status |
| Instituto De Pesquisa Clinica de Campinas (Ipecc) Coordinator of this site? Confirm its status | Campinas | Brazil | Unknown status |
| Núcleo de Pesquisa do Rio Grande do Sul Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Centro Paulista de Investigacao Clinica Cepic Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| CPQuali Pesquisa Clínica Ltda Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo Hcfmusp Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Aggarwal and Associates Ltd Coordinator of this site? Confirm its status | Brampton | Canada | Unknown status |
| CaRe Clinic Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Wharton Medical Clinic Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| Diex Recherche Trois-Rivieres Coordinator of this site? Confirm its status | Trois-Rivières | Canada | Unknown status |
| Nemocnice Rudolfa a Stefanie Benesov as Coordinator of this site? Confirm its status | Benesov U Prahy | Czechia | Unknown status |
| Fakultni nemocnice Brno Coordinator of this site? Confirm its status | Brno | Czechia | Unknown status |
| Cerebrovaskularni poradna sro Coordinator of this site? Confirm its status | Ostrava - Poruba | Czechia | Unknown status |
| Advanced Sleep Research Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| InnoDiab Forschung Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| Diabeteszentrum Hamburg West Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| Siteworks - Zentrum fuer klinische Studien Hannover Coordinator of this site? Confirm its status | Hanover | Germany | Unknown status |
| Siteworks - Zentrum fuer klinische Studien Karlsruhe Coordinator of this site? Confirm its status | Karlsruhe | Germany | Unknown status |
| RED-Institut GmbH Coordinator of this site? Confirm its status | Oldenburg | Germany | Unknown status |
| Hospital Medico Quirurgico San Rafael Coordinator of this site? Confirm its status | A Coruña | Spain | Unknown status |
| Centro Médico Teknon Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Quirón Madrid Coordinator of this site? Confirm its status | Pozuelo de Alarcón | Spain | Unknown status |
| Centre Hospitalier Universitaire D'Angers Coordinator of this site? Confirm its status | Angers | France | Unknown status |
| Centre Hospitalier Universitaire de Bordeaux Hopital Pellegrin Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon Coordinator of this site? Confirm its status | Grenoble | France | Unknown status |
| Centre Hospitalier Universitaire de Montpellier - Hopital Arnaud de Villeneuve Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud Coordinator of this site? Confirm its status | Pierre-Bénite | France | Unknown status |
| SomnoCenter Budapest Alvaszavar Kozpont Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| Debreceni Egyetem Klinikai Kozpont Coordinator of this site? Confirm its status | Debrecen | Hungary | Unknown status |
| Erzsebet Gondozohaz Coordinator of this site? Confirm its status | Gödöllő | Hungary | Unknown status |
| SomnoCenter Szeged Alvaszavar Kozpont Coordinator of this site? Confirm its status | Szeged | Hungary | Unknown status |
| Református Pulmonológiai Centrum Coordinator of this site? Confirm its status | Törökbálint | Hungary | Unknown status |
| Mazda Hospital of Mazda Motor Corporation Coordinator of this site? Confirm its status | Aki-gun | Japan | Unknown status |
| Saiseikai Futsukaichi Hospital Coordinator of this site? Confirm its status | Chikushino-shi | Japan | Unknown status |
| Fukuoka University Hospital Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Sleep and Mental Clinic-Kitahiroshima Coordinator of this site? Confirm its status | Kitahiroshima-shi | Japan | Unknown status |
| Kuwamizu Hospital Coordinator of this site? Confirm its status | Kumamoto | Japan | Unknown status |
| Goodsleep Clinic Coordinator of this site? Confirm its status | Minato-ku | Japan | Unknown status |
| Gokeikai Osaka Kaisei Hospital Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Nakamura Clinic Coordinator of this site? Confirm its status | Urasoe-shi | Japan | Unknown status |
| RESM ShinYokohama Sleep and Respiratory Medical Care Clinic Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| Uniwersytecki Szpital Kliniczny w Bialymstoku Coordinator of this site? Confirm its status | Bialystok | Poland | Unknown status |
| Uniwersytecki Szpital Kliniczny w Poznaniu Coordinator of this site? Confirm its status | Poznan | Poland | Unknown status |
| Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| NeuroTrials Research Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| FutureSearch Trials of Neurology Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Northwest Clinical Research Center Coordinator of this site? Confirm its status | Bellevue | United States | Unknown status |
| Teradan Clinical Trials Coordinator of this site? Confirm its status | Brandon | United States | Unknown status |
| CTI Clinical Research Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Epic Medical Research - DeSoto Coordinator of this site? Confirm its status | DeSoto | United States | Unknown status |
| Basil Clinical Coordinator of this site? Confirm its status | Laurelton | United States | Unknown status |
| Monroe Biomedical Research Coordinator of this site? Confirm its status | Monroe | United States | Unknown status |
| Valley Clinical Trials Coordinator of this site? Confirm its status | Northridge | United States | Unknown status |
| Destiny Research Center Coordinator of this site? Confirm its status | Palmetto Bay | United States | Unknown status |
| Clinical Research Center of Florida Coordinator of this site? Confirm its status | Pompano Beach | United States | Unknown status |
| Peninsula Research Associates Coordinator of this site? Confirm its status | Rolling Hills Estates | United States | Unknown status |
| Sleep Therapy Research Center Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.