RECRUITINGPhase 3INTERVENTIONAL
Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) Therapy
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)
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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.
Who Should NOT Join This Trial:
- Individuals who have had any previous or planned upper airway surgery for sleep apnea or major ear, nose, or throat surgery.
- Those with significant craniofacial abnormalities that may affect breathing at screening.
- Participants diagnosed with Central Apnea with a percentage of central apneas/hypopneas of 50% or more, or those diagnosed with Cheyne Stokes Respiration.
- Active device treatment of OSA (eg, PAP, oral appliances), or other treatments, that in the opinion of the investigator, may interfere with study outcomes, unless willing to stop treatment at screening and throughout the study.
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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 for sleep apnea or major ear, nose, or throat surgery.
* Those with significant craniofacial abnormalities that may affect breathing at screening.
* Participants diagnosed with Central Apnea with a percentage of central apneas/hypopneas of 50% or more, or those diagnosed with Cheyne Stokes Respiration.
* Active device treatment of OSA (eg, PAP, oral appliances), or other treatments, that in the opinion of the investigator, may interfere with study outcomes, unless willing to stop treatment at screening and throughout the study.
* 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.
Treatments Being Tested
DRUG
Maridebart cafraglutide
Participants will receive maridebart cafraglutide SC.
DRUG
Placebo
Participants will receive placebo SC.
Locations (20)
Peninsula Research Associates
Rolling Hills Estates, California, United States
Teradan Clinical Trials
Brandon, Florida, United States
Destiny Research Center
Palmetto Bay, Florida, United States
Clinical Research Center Of Florida
Pompano Beach, Florida, United States
Basil Clinical
Laurelton, New York, United States
Monroe Biomedical Research
Monroe, North Carolina, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
FutureSearch Trials of Neurology
Austin, Texas, United States
Epic Medical Research - DeSoto
DeSoto, Texas, United States
Sleep Therapy & Research Center
San Antonio, Texas, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Woolcock Institute of Medical Research
Macquarie Park, New South Wales, Australia
Royal Brisbane and Womens Hospital
Herston, Queensland, Australia
Monash Medical Centre
Clayton, Victoria, Australia
CaRe Clinic
Calgary, Alberta, Canada
Aggarwal and Associates Ltd
Brampton, Ontario, Canada
Wharton Medical Clinic
Hamilton, Ontario, Canada
Nemocnice Rudolfa a Stefanie Benesov as
Benesov U Prahy, Czechia
Cerebrovaskularni poradna sro
Ostrava - Poruba, Czechia
Advanced Sleep Research
Berlin, Germany