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NCT Number: NCT07225686

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

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.

Recruiting

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Woolcock Institute of Medical Research, Macquarie Park, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Maridebart cafraglutide

Drug

Participants will receive maridebart cafraglutide as SC injections.

Other names: AMG 133

Placebo

Drug

Participants will receive placebo SC.

Primary outcomes

  1. Change in AHI from baseline at week 52

    Time frame: At Week 52

Secondary outcomes

  1. Percentage Change in AHI from baseline at week 52

    Time frame: At Week 52

  2. Participants Achieving ≥ 50% AHI Reduction from baseline at week 52

    Time frame: At Week 52

  3. Participants Achieving AHI < 5 or AHI 5 to 14 with Epworth Sleepiness Scale (ESS) ≤ 10 from baseline at week 52

    Time frame: At Week 52

  4. Percentage Change in Body Weight from baseline at Week 52

    Time frame: At Week 52

  5. Change in Sleep Apnea-specific Hypoxic Burden (SASHB) from baseline at Week 52

    Time frame: At Week 52

  6. Change in High Sensitivity C-reactive Protein (hs-CRP) from baseline at Week 52

    Time frame: At Week 52

  7. Change in Systolic Blood Pressure from baseline at Week 48

    Time frame: At Week 48

  8. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Sleep-related Impairment 8a Score from baseline at Week 52

    Time frame: At Week 52

Study contacts

Contact information is provided by the study sponsor or research team.

Amgen Call Center

CONTACT

[email protected]

866-572-6436

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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 on Positive Airway Pressure Therapy and Living With Overweight or Obesity

Acronym: MARITIME-OSA-1

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Nov 10, 2025
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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