Actively Recruiting
Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy
Led by Amgen · Updated on 2026-05-14
250
Participants Needed
53
Research Sites
142 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Apnea-hypopnea index (AHI) of 15 or higher on polysomnography at day 1 before randomization
- Body mass index (BMI) of 27 kg/m² or higher at screening
- History of at least one unsuccessful attempt at weight loss by diet and exercise
- Receiving positive airway pressure (PAP) therapy for at least 3 consecutive months before screening and planning to continue during the trial
You will not qualify if you...
- Previous or planned upper airway surgery for sleep apnea or major ear, nose, or throat surgery
- Significant craniofacial abnormalities affecting breathing at screening
- Diagnosis of Central Apnea with 50% or more central apneas/hypopneas, or Cheyne Stokes Respiration
- Active treatment of sleep apnea with devices other than PAP therapy that may interfere with trial outcomes unless willing to stop
- Respiratory diseases like obesity hypoventilation syndrome or daytime hypercapnia, neuromuscular diseases such as myasthenia gravis, or other conditions that may interfere with trial results
- Personal or job-related circumstances preventing a 7-day PAP withdrawal before polysomnography testing during the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 53 locations
1
Valley Clinical Trials
Northridge, California, United States, 91325
Actively Recruiting
2
Peninsula Research Associates
Rolling Hills Estates, California, United States, 90274
Actively Recruiting
3
Teradan Clinical Trials
Brandon, Florida, United States, 33511
Actively Recruiting
4
Destiny Research Center
Palmetto Bay, Florida, United States, 33157
Actively Recruiting
5
Clinical Research Center Of Florida
Pompano Beach, Florida, United States, 33060
Actively Recruiting
6
NeuroTrials Research
Atlanta, Georgia, United States, 30328
Actively Recruiting
7
Basil Clinical
Laurelton, New York, United States, 11413
Actively Recruiting
8
Monroe Biomedical Research
Monroe, North Carolina, United States, 28112
Actively Recruiting
9
CTI Clinical Research Center
Cincinnati, Ohio, United States, 45212
Actively Recruiting
10
FutureSearch Trials of Neurology
Austin, Texas, United States, 78731
Actively Recruiting
11
Epic Medical Research - DeSoto
DeSoto, Texas, United States, 75115
Actively Recruiting
12
Sleep Therapy & Research Center
San Antonio, Texas, United States, 78229
Actively Recruiting
13
Northwest Clinical Research Center
Bellevue, Washington, United States, 98007
Actively Recruiting
14
Woolcock Institute of Medical Research
Macquarie Park, New South Wales, Australia, 2113
Actively Recruiting
15
Royal Brisbane and Womens Hospital
Herston, Queensland, Australia, 4006
Actively Recruiting
16
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Actively Recruiting
17
Nucleo de Pesquisa do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil, 90035-170
Actively Recruiting
18
CPQuali Pesquisa Clinica Ltda
São Paulo, São Paulo, Brazil, 01228-000
Actively Recruiting
19
Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo Hcfmusp
São Paulo, São Paulo, Brazil, 05403-900
Actively Recruiting
20
CaRe Clinic
Calgary, Alberta, Canada, T2N 4L7
Actively Recruiting
21
Aggarwal and Associates Ltd
Brampton, Ontario, Canada, L6T 0G1
Actively Recruiting
22
Wharton Medical Clinic
Hamilton, Ontario, Canada, L8L 5G8
Actively Recruiting
23
Nemocnice Rudolfa a Stefanie Benesov as
Benesov U Prahy, Czechia, 256 01
Actively Recruiting
24
Fakultni nemocnice Brno
Brno, Czechia, 625 00
Actively Recruiting
25
Cerebrovaskularni poradna sro
Ostrava - Poruba, Czechia, 708 00
Actively Recruiting
26
Centre Hospitalier Universitaire d'Angers
Angers, France, 49933
Actively Recruiting
27
Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin
Bordeaux, France, 33000
Actively Recruiting
28
Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon
Grenoble, France, 38043
Actively Recruiting
29
Hospices Civils de Lyon - Centre Hospitalier Lyon Sud
Pierre-Bénite, France, 69495
Actively Recruiting
30
Advanced Sleep Research
Berlin, Germany, 10117
Actively Recruiting
31
InnoDiab Forschung
Essen, Germany, 45136
Actively Recruiting
32
Diabeteszentrum Hamburg West
Hamburg, Germany, 22607
Actively Recruiting
33
Siteworks - Zentrum fuer klinische Studien Hannover
Hanover, Germany, 30449
Actively Recruiting
34
Siteworks - Zentrum fuer klinische Studien Karlsruhe
Karlsruhe, Germany, 76137
Actively Recruiting
35
Red-Institut GmbH
Oldenburg, Germany, 23758
Actively Recruiting
36
SomnoCenter Budapest Alvaszavar Kozpont
Budapest, Hungary, 1012
Actively Recruiting
37
Debreceni Egyetem Klinikai Kozpont
Debrecen, Hungary, 4032
Actively Recruiting
38
Erzsebet Gondozohaz
Gödöllő, Hungary, 2100
Actively Recruiting
39
SomnoCenter Szeged Alvaszavar Kozpont
Szeged, Hungary, 6720
Actively Recruiting
40
Reformatus Pulmonologiai Centrum
Törökbálint, Hungary, 2045
Actively Recruiting
41
Saiseikai Futsukaichi Hospital
Chikushino-shi, Fukuoka, Japan, 818-8516
Actively Recruiting
42
Fukuoka University Hospital
Fukuoka, Fukuoka, Japan, 814-0180
Actively Recruiting
43
Sleep and Mental Clinic-Kitahiroshima
Kitahiroshima-shi, Hokkaido, Japan, 061-1121
Actively Recruiting
44
RESM ShinYokohama Sleep and Respiratory Medical Care Clinic
Yokohama, Kanagawa, Japan, 222-0033
Actively Recruiting
45
Kuwamizu Hospital
Kumamoto, Kumamoto, Japan, 862-0954
Actively Recruiting
46
Nakamura Clinic
Urasoe-shi, Okinawa, Japan, 901-2132
Actively Recruiting
47
Gokeikai Osaka Kaisei Hospital
Osaka, Osaka, Japan, 532-0003
Actively Recruiting
48
Goodsleep Clinic
Minato-ku, Tokyo, Japan, 105-0012
Actively Recruiting
49
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
Warsaw, Poland, 04-635
Actively Recruiting
50
Centro Medico Teknon
Barcelona, Catalonia, Spain, 08022
Actively Recruiting
51
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, Spain, 08035
Actively Recruiting
52
Hospital Medico Quirurgico San Rafael
A Coruña, Galicia, Spain, 15006
Actively Recruiting
53
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
Research Team
A
Amgen Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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