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

Phase 3Active Not RecruitingNCT07225686

Amgen250 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

250

Conditions

Obesity Obstructive Sleep Apnea

Interventions

Maridebart cafraglutideDRUG

Participants will receive maridebart cafraglutide as SC injections.

PlaceboDRUG

Participants will receive placebo SC.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Locations (61)

Outcomes

Primary Outcomes

Change in Apnea-Hypopnea Index (AHI) from baseline at week 52

Time frame: At week 52

Secondary Outcomes

Percentage Change in AHI from baseline at week 52

Time frame: At week 52

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

Time frame: At week 52

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

Percentage Change in Body Weight from baseline at week 52

Time frame: At week 52

Change in Sleep Apnea-specific Hypoxic Burden (SASHB) from baseline at week 52

Time frame: At week 52

Percentage change in High Sensitivity C-reactive Protein (hs-CRP) from baseline at week 52

Time frame: At week 52

Change in Systolic Blood Pressure from baseline at week 48

Time frame: 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

Time frame: At week 52

Change in AHI from baseline at week 24

Time frame: At week 24

Percentage change in AHI from baseline at week 24

Data from ClinicalTrials.gov

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Time frame: At week 24

Change in SASHB from baseline at week 24

Time frame: At week 24

Change in ESS score from baseline at week 52

Time frame: At week 52

Change in PROMIS Short Form v1.0 Sleep Disturbance 8b score from baseline at week 52

Time frame: At week 52

Change in Short Form-36 Health Survey Version 2 (SF-36v2) Acute domain and summary scores from baseline at week 52

Time frame: At week 52

Change from baseline at week 52 in Patient Global Impression of Severity (PGI-S) Sleep-related impairment, Sleep quality, and Sleepiness.

Time frame: At week 52

Percentage of participants achieving ≥ 10% reduction in body weight from baseline at week 52

Time frame: At week 52

Percentage of participants achieving ≥ 15% reduction in body weight from baseline at week 52

Time frame: At week 52

Percentage of participants achieving ≥ 20% reduction in body weight from baseline at week 52

Time frame: At week 52

Change in waist circumference from baseline at week 52

Time frame: At week 52

Change in waist-to-height ratio from baseline at week 52

Time frame: At week 52

Change in neck circumference from baseline at week 52

Time frame: 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

Time frame: At week 52

Percent change from baseline at week 52 in fasting insulin

Time frame: At week 52

Change from baseline at week 52 in fasting plasma glucose (FPG) (mg/dL, mmol/L)

Time frame: At week 52

Change in hemoglobin A1c (HbA1c) (%, mmol/mol) from baseline at week 52

Time frame: At week 52

Change in Diastolic Blood Pressure (DBP) from baseline at week 48

Time frame: At week 48

Number of participants with Treatment-Emergent Adverse Events and Serious Adverse Events

Time frame: Up to 100 weeks

Plasma concentration of maridebart cafraglutide at week 52

Time frame: At week 52