Phase
Condition
Diabetes Prevention
Sleep Apnea Syndromes
Obesity
Treatment
Maridebart cafraglutide
Placebo
Clinical Study ID
Ages 18-99 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 beforescreening and plan to continue PAP therapy during the trial.
Exclusion
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/ordiagnosis of Cheyne Stokes Respiration.
Active device treatment of obstructive sleep apnea other than PAP therapy (eg, oralappliances), or other treatments, that in the opinion of the investigator, mayinterfere with trial outcomes, unless willing to stop treatment at screening andthroughout the trial.
Respiratory diseases such as obesity hypoventilation syndrome or daytimehypercapnia, or neuromuscular diseases such as myasthenia gravis or other conditionsthat could interfere with the results of the trial in the opinion of theinvestigator.
Have personal circumstances or job-related responsibilities that prevent a 7-day PAPwithdrawal before polysomnography testing during the course of the trial.
Study Design
Connect with a study center
Woolcock Institute of Medical Research
Macquarie Park, New South Wales 2113
AustraliaActive - Recruiting
Woolcock Institute of Medical Research
Macquarie Park 8347858, New South Wales 2155400 2113
AustraliaSite Not Available
Royal Brisbane and Womens Hospital
Herston, Queensland 4006
AustraliaActive - Recruiting
Royal Brisbane and Womens Hospital
Herston 6931014, Queensland 2152274 4006
AustraliaSite Not Available
Monash Medical Centre
Clayton, Victoria 3168
AustraliaActive - Recruiting
Nucleo de Pesquisa do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul 90035-170
BrazilActive - Recruiting
CPQuali Pesquisa Clinica Ltda
São Paulo, São Paulo 01228-000
BrazilActive - Recruiting
Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo Hcfmusp
São Paulo, São Paulo 05403-900
BrazilActive - Recruiting
CaRe Clinic
Calgary, Alberta T2N 4L7
CanadaActive - Recruiting
CaRe Clinic
Calgary 5913490, Alberta 5883102 T2N 4L7
CanadaSite Not Available
Aggarwal and Associates Ltd
Brampton, Ontario L6T 0G1
CanadaActive - Recruiting
Wharton Medical Clinic
Hamilton, Ontario L8L 5G8
CanadaActive - Recruiting
Aggarwal and Associates Ltd
Brampton 5907364, Ontario 6093943 L6T 0G1
CanadaSite Not Available
Wharton Medical Clinic
Hamilton 5969782, Ontario 6093943 L8L 5G8
CanadaSite Not Available
Nemocnice Rudolfa a Stefanie Benesov as
Benesov U Prahy, 256 01
CzechiaActive - Recruiting
Fakultni nemocnice Brno
Brno, 625 00
CzechiaActive - Recruiting
Cerebrovaskularni poradna sro
Ostrava - Poruba, 708 00
CzechiaActive - Recruiting
Centre Hospitalier Universitaire d'Angers
Angers, 49933
FranceActive - Recruiting
Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin
Bordeaux, 33000
FranceActive - Recruiting
Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon
Grenoble, 38043
FranceActive - Recruiting
Hospices Civils de Lyon - Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
FranceActive - Recruiting
Advanced Sleep Research
Berlin, 10117
GermanyActive - Recruiting
InnoDiab Forschung
Essen, 45136
GermanyActive - Recruiting
Diabeteszentrum Hamburg West
Hamburg, 22607
GermanyActive - Recruiting
Diabeteszentrum Hamburg West
Hamburg 2911298, 22607
GermanySite Not Available
Siteworks - Zentrum fuer klinische Studien Hannover
Hanover, 30449
GermanyActive - Recruiting
Siteworks - Zentrum fuer klinische Studien Hannover
Hanover 2910831, 30449
GermanySite Not Available
Siteworks - Zentrum fuer klinische Studien Karlsruhe
Karlsruhe, 76137
GermanyActive - Recruiting
Siteworks - Zentrum fuer klinische Studien Karlsruhe
Karlsruhe 2892794, 76137
GermanySite Not Available
Red-Institut GmbH
Oldenburg, 23758
GermanyActive - Recruiting
Red-Institut GmbH
Oldenburg 2857458, 23758
GermanySite Not Available
SomnoCenter Budapest Alvaszavar Kozpont
Budapest, 1012
HungaryActive - Recruiting
SomnoCenter Budapest Alvaszavar Kozpont
Budapest 3054643, 1012
HungarySite Not Available
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032
HungaryActive - Recruiting
Debreceni Egyetem Klinikai Kozpont
Debrecen 721472, 4032
HungarySite Not Available
Erzsebet Gondozohaz
Gödöllő, 2100
HungaryActive - Recruiting
SomnoCenter Szeged Alvaszavar Kozpont
Szeged, 6720
HungaryActive - Recruiting
Reformatus Pulmonologiai Centrum
Törökbálint, 2045
HungaryActive - Recruiting
Reformatus Pulmonologiai Centrum
Törökbálint 3043778, 2045
HungarySite Not Available
Saiseikai Futsukaichi Hospital
Chikushino-shi, Fukuoka 818-8516
JapanActive - Recruiting
Fukuoka University Hospital
Fukuoka, Fukuoka 814-0180
JapanActive - Recruiting
Fukuoka University Hospital
Fukuoka 1863967, Fukuoka 1863958 814-0180
JapanSite Not Available
Sleep and Mental Clinic-Kitahiroshima
Kitahiroshima-shi, Hokkaido 061-1121
JapanActive - Recruiting
Social Medical Corporation Sokujinkai Sleep and Mental Clinic Kitahiroshima
Kitahiroshima-shi, Hokkaido 061-1121
JapanActive - Recruiting
RESM ShinYokohama Sleep and Respiratory Medical Care Clinic
Yokohama, Kanagawa 222-0033
JapanActive - Recruiting
Kuwamizu Hospital
Kumamoto, Kumamoto 862-0954
JapanActive - Recruiting
Nakamura Clinic
Urasoe-shi, Okinawa 901-2132
JapanActive - Recruiting
Gokeikai Osaka Kaisei Hospital
Osaka, Osaka 532-0003
JapanActive - Recruiting
Goodsleep Clinic
Minato-ku, Tokyo 105-0012
JapanActive - Recruiting
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
Warsaw, 04-635
PolandActive - Recruiting
Centro Medico Teknon
Barcelona, Catalonia 08022
SpainActive - Recruiting
Hospital Universitari Vall d Hebron
Barcelona, Catalonia 08035
SpainActive - Recruiting
Hospital Medico Quirurgico San Rafael
A Coruña, Galicia 15006
SpainActive - Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
SpainActive - Recruiting
Valley Clinical Trials
Northridge, California 91325
United StatesActive - Recruiting
Peninsula Research Associates
Rolling Hills Estates, California 90274
United StatesActive - Recruiting
Peninsula Research Associates
Rolling Hills Estates 5388601, California 5332921 90274
United StatesSite Not Available
Teradan Clinical Trials
Brandon, Florida 33511
United StatesActive - Recruiting
Destiny Research Center
Palmetto Bay, Florida 33157
United StatesActive - Recruiting
Clinical Research Center Of Florida
Pompano Beach, Florida 33060
United StatesActive - Recruiting
Teradan Clinical Trials
Brandon 4148757, Florida 4155751 33511
United StatesSite Not Available
Destiny Research Center
Palmetto Bay 4167634, Florida 4155751 33157
United StatesSite Not Available
Clinical Research Center Of Florida
Pompano Beach 4169014, Florida 4155751 33060
United StatesSite Not Available
NeuroTrials Research
Atlanta, Georgia 30328
United StatesActive - Recruiting
Basil Clinical
Laurelton, New York 11413
United StatesActive - Recruiting
Basil Clinical
Laurelton 5124078, New York 5128638 11413
United StatesSite Not Available
Monroe Biomedical Research
Monroe, North Carolina 28112
United StatesActive - Recruiting
Monroe Biomedical Research
Monroe 4479946, North Carolina 4482348 28112
United StatesSite Not Available
CTI Clinical Research Center
Cincinnati, Ohio 45212
United StatesActive - Recruiting
CTI Clinical Research Center
Cincinnati 4508722, Ohio 5165418 45212
United StatesSite Not Available
FutureSearch Trials of Neurology
Austin, Texas 78731
United StatesActive - Recruiting
Epic Medical Research - DeSoto
DeSoto, Texas 75115
United StatesActive - Recruiting
Sleep Therapy & Research Center
San Antonio, Texas 78229
United StatesActive - Recruiting
FutureSearch Trials of Neurology
Austin 4671654, Texas 4736286 78731
United StatesSite Not Available
Epic Medical Research - DeSoto
DeSoto 4685524, Texas 4736286 75115
United StatesSite Not Available
Sleep Therapy & Research Center
San Antonio 4726206, Texas 4736286 78229
United StatesSite Not Available
Northwest Clinical Research Center
Bellevue, Washington 98007
United StatesActive - Recruiting
Northwest Clinical Research Center
Bellevue 5786882, Washington 5815135 98007
United StatesSite Not Available

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