Maridebart Cafraglutide for Obstructive Sleep Apnea
Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) Therapy
Recruiting
Phase 3Interventional Study
Obstructive Sleep Apnea
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 99
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
250 (estimated)
Sponsor
Amgen · Industry
Who this trial is looking for
This trial is looking for adults with obstructive sleep apnea who are overweight or obese and not using CPAP machines. Participants will receive either maridebart cafraglutide or a placebo for one year.
Are You a Good Fit for This Trial?
You may be able to join if
I have obstructive sleep apnea with an AHI of 15 or higher.
I have a Body Mass Index (BMI) of 27 or more.
I have tried to lose weight before but was not successful.
I have not used a CPAP machine for at least 4 weeks.
You may not be able to join if
I have had any surgery for my breathing problems before.
I have significant facial abnormalities that affect my breathing.
I have been diagnosed with Central or Mixed Sleep Apnea.
I am currently using devices or other treatments for sleep apnea.
I have respiratory diseases like obesity hypoventilation syndrome.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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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…
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.
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