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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Apnea-Hypopnea Index (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 |
| Percentage 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 |
| Change in AHI from baseline at week 24 | At week 24 |
| Percentage change in AHI from baseline at week 24 | At week 24 |
| Change in SASHB from baseline at week 24 | At week 24 |
| Change in ESS score from baseline at week 52 | At week 52 |
| Change in PROMIS Short Form v1.0 Sleep Disturbance 8b score from baseline at week 52 | At week 52 |
| Change in Short Form-36 Health Survey Version 2 (SF-36v2) Acute domain and summary scores from baseline at week 52 | At week 52 |
| Change from baseline at week 52 in Patient Global Impression of Severity (PGI-S) Sleep-related impairment, Sleep quality, and Sleepiness. | At week 52 |
| Percentage of participants achieving ≥ 10% reduction in body weight from baseline at week 52 | At week 52 |
| Percentage of participants achieving ≥ 15% reduction in body weight from baseline at week 52 | At week 52 |
| Percentage of participants achieving ≥ 20% reduction in body weight from baseline at week 52 | At week 52 |
| Change in waist circumference from baseline at week 52 | At week 52 |
| Change in waist-to-height ratio from baseline at week 52 | At week 52 |
| Change in neck circumference from baseline at week 52 | At week 52 |
| Percentage change in Total Cholesterol, High-density lipoprotein cholesterol (HDL-C), Non-HDL-C, Low-density lipoprotein cholesterol (LDL-C), and Triglycerides from baseline at week 52 in fasting conditions | At week 52 |
| Percent change from baseline at week 52 in fasting insulin | At week 52 |
| Change from baseline at week 52 in fasting plasma glucose (FPG) (mg/dL, mmol/L) | At week 52 |
| Change in hemoglobin A1c (HbA1c) (%, mmol/mol) from baseline at week 52 | At week 52 |
| Change in Diastolic Blood Pressure (DBP) from baseline at week 48 | At week 48 |
| Number of participants with Treatment-Emergent Adverse Events and Serious Adverse Events | Up to 100 weeks |
| Plasma concentration of maridebart cafraglutide at week 52 | At week 52 |
Countries
Australia, Brazil, Canada, Czechia, France, Germany, Hungary, Japan, Poland, Spain, United States
Contacts
CONTACTAmgen Call Center
STUDY_DIRECTORMD
Amgen
Outcome results
None listed