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

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified April 2026 by Amgen
Sponsor
Amgen
Information Provided by (Responsible Party)
Amgen
Clinicaltrials.gov Identifier
NCT07225686
Other Study ID Numbers:
20230225
First Submitted
November 4, 2025
First Posted
November 9, 2025
Last Update Posted
May 13, 2026
Last Verified
April 2026

ClinicalTrials.gov processed this data on May 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
ObesityObstructive Sleep Apnea
Drug: Maridebart cafraglutideDrug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment250 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingDouble
Primary PurposeTreatment
Official TitleA 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
Study Start DateDecember 18, 2025
Actual Primary Completion Date1yr 4mos from now
Actual Study Completion Date2yrs 3mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Maridebart Cafraglutide
Participants will receive maridebart cafraglutide subcutaneously (SC).
Drug: Maridebart cafraglutide
Participants will receive maridebart cafraglutide as SC injections.
Placebo
Participants will receive placebo SC.
Drug: Placebo
Participants will receive placebo SC.

Outcome Measures

Primary Outcome Measures
  1. Change in AHI from baseline at week 52
Secondary Outcome Measures
  1. Percentage Change in AHI from baseline at week 52
  2. Participants Achieving ≥ 50% AHI Reduction from baseline at week 52
  3. Participants Achieving AHI < 5 or AHI 5 to 14 with Epworth Sleepiness Scale (ESS) ≤ 10 from baseline at week 52
  4. Percentage Change in Body Weight from baseline at Week 52
  5. Change in Sleep Apnea-specific Hypoxic Burden (SASHB) from baseline at Week 52
  6. Change in High Sensitivity C-reactive Protein (hs-CRP) from baseline at Week 52
  7. Change in Systolic Blood Pressure from baseline at Week 48
  8. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Sleep-related Impairment 8a Score from baseline at Week 52

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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 for sleep apnea or major ear, nose, or throat surgery.
Significant craniofacial abnormalities that may affect breathing at screening.
Diagnosis of Central Apnea with % of central apneas/hypopneas ≥ 50%, and/or diagnosis of Cheyne Stokes Respiration.
Active device treatment of obstructive sleep apnea other than PAP therapy (eg, oral appliances), or other treatments, that in the opinion of the investigator, may interfere with trial outcomes, unless willing to stop treatment at screening and throughout the trial.
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.

Contacts and Locations

Sponsors and CollaboratorsAmgen
Locations
Valley Clinical Trials | Northridge California, United States, 91325Peninsula Research Associates | Rolling Hills Estates California, United States, 90274Teradan Clinical Trials | Brandon Florida, United States, 33511Destiny Research Center | Palmetto Bay Florida, United States, 33157Clinical Research Center Of Florida | Pompano Beach Florida, United States, 33060NeuroTrials Research | Atlanta Georgia, United States, 30328Basil Clinical | Laurelton New York, United States, 11413Monroe Biomedical Research | Monroe North Carolina, United States, 28112CTI Clinical Research Center | Cincinnati Ohio, United States, 45212FutureSearch Trials of Neurology | Austin Texas, United States, 78731Epic Medical Research - DeSoto | DeSoto Texas, United States, 75115Sleep Therapy & Research Center | San Antonio Texas, United States, 78229Northwest Clinical Research Center | Bellevue Washington, United States, 98007Woolcock Institute of Medical Research | Macquarie Park New South Wales, Australia, 2113Royal Brisbane and Womens Hospital | Herston Queensland, Australia, 4006Monash Medical Centre | Clayton Victoria, Australia, 3168Nucleo de Pesquisa do Rio Grande do Sul | Porto Alegre Rio Grande do Sul, Brazil, 90035-170CPQuali Pesquisa Clinica Ltda | São Paulo São Paulo, Brazil, 01228-000Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo Hcfmusp | São Paulo São Paulo, Brazil, 05403-900CaRe Clinic | Calgary Alberta, Canada, T2N 4L7Aggarwal and Associates Ltd | Brampton Ontario, Canada, L6T 0G1Wharton Medical Clinic | Hamilton Ontario, Canada, L8L 5G8Nemocnice Rudolfa a Stefanie Benesov as | Benesov U Prahy , Czechia, 256 01Fakultni nemocnice Brno | Brno , Czechia, 625 00Cerebrovaskularni poradna sro | Ostrava - Poruba , Czechia, 708 00Centre Hospitalier Universitaire d'Angers | Angers , France, 49933Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin | Bordeaux , France, 33000Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon | Grenoble , France, 38043Hospices Civils de Lyon - Centre Hospitalier Lyon Sud | Pierre-Bénite , France, 69495Advanced Sleep Research | Berlin , Germany, 10117InnoDiab Forschung | Essen , Germany, 45136Diabeteszentrum Hamburg West | Hamburg , Germany, 22607Siteworks - Zentrum fuer klinische Studien Hannover | Hanover , Germany, 30449Siteworks - Zentrum fuer klinische Studien Karlsruhe | Karlsruhe , Germany, 76137Red-Institut GmbH | Oldenburg , Germany, 23758SomnoCenter Budapest Alvaszavar Kozpont | Budapest , Hungary, 1012Debreceni Egyetem Klinikai Kozpont | Debrecen , Hungary, 4032Erzsebet Gondozohaz | Gödöllő , Hungary, 2100SomnoCenter Szeged Alvaszavar Kozpont | Szeged , Hungary, 6720Reformatus Pulmonologiai Centrum | Törökbálint , Hungary, 2045Saiseikai Futsukaichi Hospital | Chikushino-shi Fukuoka, Japan, 818-8516Fukuoka University Hospital | Fukuoka Fukuoka, Japan, 814-0180Sleep and Mental Clinic-Kitahiroshima | Kitahiroshima-shi Hokkaido, Japan, 061-1121RESM ShinYokohama Sleep and Respiratory Medical Care Clinic | Yokohama Kanagawa, Japan, 222-0033Kuwamizu Hospital | Kumamoto Kumamoto, Japan, 862-0954Nakamura Clinic | Urasoe-shi Okinawa, Japan, 901-2132Gokeikai Osaka Kaisei Hospital | Osaka Osaka, Japan, 532-0003Goodsleep Clinic | Minato-ku Tokyo, Japan, 105-0012Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy | Warsaw , Poland, 04-635Centro Medico Teknon | Barcelona Catalonia, Spain, 08022Hospital Universitari Vall d Hebron | Barcelona Catalonia, Spain, 08035Hospital Medico Quirurgico San Rafael | A Coruña Galicia, Spain, 15006Hospital Universitario 12 de Octubre | Madrid , Spain, 28041
Investigators
Study Director: MD, Amgen