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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 receiving positive airway pressure (PAP) therapy and are living with overweight or obesity.

Conditions

Eligibility

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

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 before screening and plan to continue PAP therapy during the trial.

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/or diagnosis of Cheyne Stokes Respiration. - Active device treatment of obstructive sleep apnea other than PAP therapy (eg, oral appliances), or other treatments, that in the opinion of the investigator, may interfere with trial outcomes, unless willing to stop treatment at screening and throughout the trial. - Respiratory diseases such as obesity hypoventilation syndrome or daytime hypercapnia, or neuromuscular diseases such as myasthenia gravis or other conditions that could interfere with the results of the trial in the opinion of the investigator. - Have personal circumstances or job-related responsibilities that prevent a 7-day PAP withdrawal before polysomnography testing during the course of the trial.

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 as SC injections.
    Other names:
    • AMG 133
Placebo Comparator
Placebo 		Participants will receive placebo SC.
  • Drug: Placebo
    Participants will receive placebo SC.

Recruiting Locations

Valley Clinical Trials
Northridge, California 91325

Peninsula Research Associates
Rolling Hills Estates, California 90274

Teradan Clinical Trials
Brandon, Florida 33511

Destiny Research Center
Palmetto Bay, Florida 33157

Clinical Research Center Of Florida
Pompano Beach, Florida 33060

NeuroTrials Research
Atlanta, Georgia 30328

Basil Clinical
Laurelton, New York 11413

Monroe Biomedical Research
Monroe, North Carolina 28112

CTI Clinical Research Center
Cincinnati, Ohio 45212

FutureSearch Trials of Neurology
Austin, Texas 78731

Epic Medical Research - DeSoto
DeSoto, Texas 75115

Sleep Therapy & Research Center
San Antonio, Texas 78229

Northwest Clinical Research Center
Bellevue, Washington 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.