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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 99 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Maridebart Cafraglutide 		Participants will receive maridebart cafraglutide subcutaneously (SC).
  • Drug: Maridebart cafraglutide
    Participants will receive maridebart cafraglutide SC.
    Other names:
    • AMG 133
    • MariTide
Placebo Comparator
Placebo 		Participants will receive placebo SC.
  • Drug: Placebo
    Participants will receive placebo SC.

Recruiting Locations

Peninsula Research Associates
Rolling Hills Estates 5388601, California 5332921 90274

Teradan Clinical Trials
Brandon 4148757, Florida 4155751 33511

Destiny Research Center
Palmetto Bay 4167634, Florida 4155751 33157

Clinical Research Center Of Florida
Pompano Beach 4169014, Florida 4155751 33060

Basil Clinical
Laurelton 5124078, New York 5128638 11413

Monroe Biomedical Research
Monroe 4479946, North Carolina 4482348 28112

CTI Clinical Research Center
Cincinnati 4508722, Ohio 5165418 45212

FutureSearch Trials of Neurology
Austin 4671654, Texas 4736286 78731

Epic Medical Research - DeSoto
DeSoto 4685524, Texas 4736286 75115

Sleep Therapy & Research Center
San Antonio 4726206, Texas 4736286 78229

Northwest Clinical Research Center
Bellevue 5786882, Washington 5815135 98007

More Details

Status
Recruiting
Sponsor
Amgen

Study Contact

Amgen Call Center
866-572-6436
medinfo@amgen.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.