Actively Recruiting
Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) Therapy
Led by Amgen · Updated on 2026-05-14
250
Participants Needed
46
Research Sites
146 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 not on PAP therapy and are living with overweight or obesity.
CONDITIONS
Official Title
Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have an apnea-hypopnea index (AHI) of 15 or higher on sleep study before randomization
- Body mass index (BMI) of 27 kg/m² or more at screening
- History of at least one unsuccessful attempt to lose weight through diet and exercise
- No use of positive airway pressure (PAP) therapy for at least 4 weeks before screening and unwilling or unable to use PAP during the study
You will not qualify if you...
- Previous or planned upper airway or major ear, nose, or throat surgery for sleep apnea
- Significant craniofacial abnormalities affecting breathing
- Central apnea with 50% or more central apneas/hypopneas or diagnosis of Cheyne Stokes Respiration
- Active use of OSA devices or treatments that may interfere with study outcomes unless stopped before and during the study
- Respiratory diseases like obesity hypoventilation syndrome or daytime hypercapnia
- Neuromuscular diseases or other conditions that might interfere with study results according to the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 46 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, 90430-001
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
Advanced Sleep Research
Berlin, Germany, 10117
Actively Recruiting
27
InnoDiab Forschung
Essen, Germany, 45136
Actively Recruiting
28
Diabeteszentrum Hamburg West
Hamburg, Germany, 22607
Actively Recruiting
29
Siteworks - Zentrum fuer klinische Studien Hannover
Hanover, Germany, 30449
Actively Recruiting
30
Siteworks - Zentrum fuer klinische Studien Karlsruhe
Karlsruhe, Germany, 76137
Actively Recruiting
31
Red-Institut GmbH
Oldenburg, Germany, 23758
Actively Recruiting
32
SomnoCenter Budapest Alvaszavar Kozpont
Budapest, Hungary, 1012
Actively Recruiting
33
Reformatus Pulmonologiai Centrum
Törökbálint, Hungary, 2045
Actively Recruiting
34
Saiseikai Futsukaichi Hospital
Chikushino-shi, Fukuoka, Japan, 818-8516
Actively Recruiting
35
Fukuoka University Hospital
Fukuoka, Fukuoka, Japan, 814-0180
Actively Recruiting
36
Sleep and Mental Clinic-Kitahiroshima
Kitahiroshima-shi, Hokkaido, Japan, 061-1121
Actively Recruiting
37
RESM ShinYokohama Sleep and Respiratory Medical Care Clinic
Yokohama, Kanagawa, Japan, 222-0033
Actively Recruiting
38
Kuwamizu Hospital
Kumamoto, Kumamoto, Japan, 862-0954
Actively Recruiting
39
Nakamura Clinic
Urasoe-shi, Okinawa, Japan, 901-2132
Actively Recruiting
40
Gokeikai Osaka Kaisei Hospital
Osaka, Osaka, Japan, 532-0003
Actively Recruiting
41
Goodsleep Clinic
Minato-ku, Tokyo, Japan, 105-0012
Actively Recruiting
42
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
Warsaw, Poland, 04-635
Actively Recruiting
43
Centro Medico Teknon
Barcelona, Catalonia, Spain, 08022
Actively Recruiting
44
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, Spain, 08035
Actively Recruiting
45
Hospital Medico Quirurgico San Rafael
A Coruña, Galicia, Spain, 15006
Actively Recruiting
46
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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