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Clinical Trials in the USA / NCT07226765
Recruiting Phase 3

Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) Therapy

NCT07226765 · tracked via the Priya Life Science USA tracker
Sponsor
Amgen
Phase
Phase 3
Started
2025-11-25
Last updated
2026-08-14

Condition(s) studied

Obstructive Sleep Apnea

Investigational drug(s) / intervention(s)

Maridebart cafraglutidePlacebo

Maridebart cafraglutide: Participants will receive maridebart cafraglutide SC.

Placebo: Participants will receive placebo SC.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (57)

FacilityCityRegionStatus
Valley Clinical Trials Northridge California Recruiting
Peninsula Research Associates Rolling Hills Estates California Recruiting
Teradan Clinical Trials Brandon Florida Recruiting
Destiny Research Center Palmetto Bay Florida Recruiting
Clinical Research Center Of Florida Pompano Beach Florida Recruiting
NeuroTrials Research Atlanta Georgia Recruiting
Basil Clinical Laurelton New York Recruiting
Monroe Biomedical Research Monroe North Carolina Recruiting
CTI Clinical Research Center Cincinnati Ohio Recruiting
FutureSearch Trials of Neurology Austin Texas Recruiting
Epic Medical Research - DeSoto DeSoto Texas Recruiting
Sleep Therapy & Research Center San Antonio Texas Recruiting
Northwest Clinical Research Center Bellevue Washington Recruiting
Woolcock Institute of Medical Research Macquarie Park New South Wales Recruiting
Royal Brisbane and Womens Hospital Herston Queensland Recruiting
Monash Medical Centre Clayton Victoria Recruiting
Nucleo de Pesquisa do Rio Grande do Sul Porto Alegre Rio Grande do Sul Recruiting
Instituto de Pesquisa Clinica de Campinas - Ipecc Campinas São Paulo Recruiting
CPQuali Pesquisa Clinica Ltda São Paulo São Paulo Recruiting
Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo Hcfmusp São Paulo São Paulo Recruiting
Centro Paulista de Investigacao Clinica Cepic São Paulo Brazil Recruiting
CaRe Clinic Calgary Alberta Recruiting
Aggarwal and Associates Ltd Brampton Ontario Recruiting
Wharton Medical Clinic Hamilton Ontario Recruiting
Diex Recherche Trois Rivieres Trois-Rivières Quebec Recruiting
Nemocnice Rudolfa a Stefanie Benesov as Benesov U Prahy Czechia Recruiting
Fakultni nemocnice Brno Brno Czechia Recruiting
Cerebrovaskularni poradna sro Ostrava - Poruba Czechia Recruiting
Centre Hospitalier Universitaire d'Angers Angers France Recruiting
Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin Bordeaux France Recruiting
Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon Grenoble France Recruiting
Advanced Sleep Research Berlin Germany Recruiting
InnoDiab Forschung Essen Germany Recruiting
Diabeteszentrum Hamburg West Hamburg Germany Recruiting
Siteworks - Zentrum fuer klinische Studien Hannover Hanover Germany Recruiting
Siteworks - Zentrum fuer klinische Studien Karlsruhe Karlsruhe Germany Recruiting
Red-Institut GmbH Oldenburg Germany Recruiting
SomnoCenter Budapest Alvaszavar Kozpont Budapest Hungary Recruiting
Debreceni Egyetem Klinikai Kozpont Debrecen Hungary Recruiting
Reformatus Pulmonologiai Centrum Törökbálint Hungary Recruiting

+ 17 more sites — see the full list on the official registry below.

More Amgen trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07226765 on ClinicalTrials.gov ↗ ← All trials in the USA