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Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy
Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy

NCT07225686

RecruitingPhase 3

Sponsor: Amgen

Conditions: Obesity, 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 receiving positive airway pressure (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:

* 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 or major ear, nose, or throat surgery for OSA.
* Significant craniofacial abnormalities that may affect breathing at screening.
* Diagnosis of 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 other than PAP therapy (eg, oral appliances), or other treatments, that in the opinion of the investigator, may interfere with study outcomes.
* 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.
Locations (61)
  • 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
  • + 31 more on CT.gov