Obstructive Sleep Apnea
Conditions
Keywords
Obstructive sleep apnea, OSA, Overweight, Obesity, Maridebart Cafraglutide, AMG 133, MariTide
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 not on PAP therapy and are living with overweight or obesity.
Interventions
Participants will receive maridebart cafraglutide SC.
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
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Apnea-hypopnea Index (AHI) from baseline at Week 52 | At Week 52 |
Secondary
| Measure | Time frame |
|---|---|
| Change in AHI from Baseline at Week 24 | At Week 24 |
| Percent 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-related Impairment 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 in Patient Global Impression of Severity (PGI-S) Sleep-Related Impairment, Sleep Quality, Sleepiness from Baseline at Week 52 | 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 in Fasting Insulin From Baseline at Week 52 | At Week 52 |
| Change in Fasting Plasma Glucose (FPG) (mg/dL, mmol/L) From Baseline at Week 52 | At Week 52 |
| Change in Hemoglobin A1c 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 Week 100 |
| Plasma Concentration of Maridebart Cafraglutide at Week 52 | At Week 52 |
| Change in Systolic Blood Pressure (SBP) from baseline at Week 48 | At Week 48 |
| Percent 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 |
| Percent 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 Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Sleep-related Impairment 8a Score from baseline at Week 52 | At Week 52 |
| Percent Change in High Sensitivity C-reactive Protein (hs-CRP) from baseline 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