Obesity, Obstructive Sleep Apnea
Conditions
Keywords
MariTide, Maridebart Cafraglutide, AMG 133, Obesity
Brief summary
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.
Interventions
Participants will receive maridebart cafraglutide as SC injections.
DRUGPlacebo
Participants will receive placebo SC.
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in AHI from baseline at week 52 | At Week 52 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage Change in AHI from baseline at week 52 | At Week 52 |
| Participants Achieving ≥ 50% AHI Reduction from baseline at week 52 | At Week 52 |
| Participants Achieving AHI < 5 or AHI 5 to 14 with Epworth Sleepiness Scale (ESS) ≤ 10 from baseline at week 52 | At Week 52 |
| Percentage Change in Body Weight from baseline at Week 52 | At Week 52 |
| Change in Sleep Apnea-specific Hypoxic Burden (SASHB) from baseline at Week 52 | At Week 52 |
| Change in High Sensitivity C-reactive Protein (hs-CRP) from baseline at Week 52 | At Week 52 |
| Change in Systolic Blood Pressure from baseline at Week 48 | At Week 48 |
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Sleep-related Impairment 8a Score from baseline at Week 52 | At Week 52 |
Countries
Australia, Canada, Czechia, France, Germany, Hungary, Japan, Poland, Spain, United States
Contacts
CONTACTAmgen Call Center
STUDY_DIRECTORMD
Amgen
Outcome results
None listed