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Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) Therapy
Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) Therapy

NCT07226765

RecruitingPhase 3

Sponsor: Amgen

Conditions: Obstructive Sleep Apnea

Interventions: Maridebart cafraglutide, Placebo

Countries: United States, Australia, Brazil, Canada, Czechia, France, Germany, Hungary

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 overview

Sex: ALL

Age: 18 Years to 99 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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 or major ear, nose or throat surgery for OSA.
* Those with significant craniofacial abnormalities that may affect breathing at screening.
* Participants diagnosed with Central or Mixed Sleep Apnea with proportion of mixed or central apneas/hypopneas ≥ 50%, and/or diagnosis of Cheyne Stokes Respiration.
* Active device treatment of OSA or other treatments, that in the opinion of the investigator, may interfere with study outcomes.
* 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.
Locations (57)
  • Northridge, California, United States
  • Rolling Hills Estates, California, United States
  • Brandon, Florida, United States
  • Palmetto Bay, Florida, United States
  • Pompano Beach, Florida, United States
  • Atlanta, Georgia, United States
  • Laurelton, New York, United States
  • Monroe, North Carolina, United States
  • Cincinnati, Ohio, United States
  • Austin, Texas, United States
  • DeSoto, Texas, United States
  • San Antonio, Texas, United States
  • Bellevue, Washington, United States
  • Macquarie Park, New South Wales, Australia
  • Herston, Queensland, Australia
  • Clayton, Victoria, Australia
  • Porto Alegre, Rio Grande do Sul, Brazil
  • Campinas, São Paulo, Brazil
  • São Paulo, São Paulo, Brazil
  • São Paulo, São Paulo, Brazil
  • São Paulo, Brazil
  • Calgary, Alberta, Canada
  • Brampton, Ontario, Canada
  • Hamilton, Ontario, Canada
  • Trois-Rivières, Quebec, Canada
  • Benesov U Prahy, Czechia
  • Brno, Czechia
  • Ostrava - Poruba, Czechia
  • Angers, France
  • Bordeaux, France
  • + 27 more on CT.gov