A 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 Not on Positive Airway Pressure Therapy and Living With Overweight or Obesity (MARITIME-OSA-2)
Status: Recruiting
Location: See all (32) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
Valley Clinical Trials
RECRUITING
Northridge
Peninsula Research Associates
RECRUITING
Rolling Hills Estates
Florida
Teradan Clinical Trials
RECRUITING
Brandon
Destiny Research Center
RECRUITING
Palmetto Bay
Clinical Research Center Of Florida
RECRUITING
Pompano Beach
Georgia
NeuroTrials Research
RECRUITING
Atlanta
North Carolina
Monroe Biomedical Research
RECRUITING
Monroe
New York
Basil Clinical
RECRUITING
Laurelton
Ohio
CTI Clinical Research Center
RECRUITING
Cincinnati
Texas
FutureSearch Trials of Neurology
RECRUITING
Austin
Epic Medical Research - DeSoto
RECRUITING
Desoto
Sleep Therapy & Research Center
RECRUITING
San Antonio
Washington
Northwest Clinical Research Center
RECRUITING
Bellevue
Other Locations
Australia
Monash Medical Centre
RECRUITING
Clayton
Royal Brisbane and Womens Hospital
RECRUITING
Herston
Woolcock Institute of Medical Research
RECRUITING
Macquarie Park
Canada
Aggarwal and Associates Ltd
RECRUITING
Brampton
CaRe Clinic
RECRUITING
Calgary
Wharton Medical Clinic
RECRUITING
Hamilton
Germany
Advanced Sleep Research
RECRUITING
Berlin
InnoDiab Forschung
RECRUITING
Essen
Diabeteszentrum Hamburg West
RECRUITING
Hamburg
Siteworks - Zentrum fuer klinische Studien Hannover
RECRUITING
Hanover
Siteworks - Zentrum fuer klinische Studien Karlsruhe
RECRUITING
Karlsruhe
Red-Institut GmbH
RECRUITING
Oldenburg
Japan
Saiseikai Futsukaichi Hospital
RECRUITING
Chikushino-shi
Fukuoka University Hospital
RECRUITING
Fukuoka
Social Medical Corporation Sokujinkai Sleep and Mental Clinic Kitahiroshima
RECRUITING
Kitahiroshima-shi
Kuwamizu Hospital
RECRUITING
Kumamoto
Nakamura Clinic
RECRUITING
Urasoe-shi
Spain
Hospital Medico Quirurgico San Rafael
RECRUITING
A Coruña
Centro Medico Teknon
RECRUITING
Barcelona
Contact Information
Primary
Amgen Call Center
medinfo@amgen.com
866-572-6436
Time Frame
Start Date: 2025-11-25
Estimated Completion Date: 2028-09-13
Participants
Target number of participants: 250
Treatments
Experimental: Maridebart Cafraglutide
Participants will receive maridebart cafraglutide subcutaneously (SC).
Placebo_comparator: Placebo
Participants will receive placebo SC.
Related Therapeutic Areas
Sponsors
Leads: Amgen