Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) Therapy

Phase 3RecruitingNCT07226765

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 not on PAP therapy and are living with overweight or obesity.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

250

Conditions

Obstructive Sleep Apnea

Interventions

Maridebart cafraglutideDRUG

Participants will receive maridebart cafraglutide SC.

PlaceboDRUG

Participants will receive placebo SC.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Locations (57)

Outcomes

Primary Outcomes

Change in Apnea-hypopnea Index (AHI) from baseline at Week 52

Time frame: At Week 52

Secondary Outcomes

Percent 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

Percent 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

Percent Change in High Sensitivity C-reactive Protein (hs-CRP) from baseline at Week 52

Time frame: At Week 52

Change in Systolic Blood Pressure (SBP) 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

Percent Change in AHI from Baseline at Week 24

Central Contacts

Amgen Call Center

CONTACT

866-572-6436 medinfo@amgen.com

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-related Impairment 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 in Patient Global Impression of Severity (PGI-S) Sleep-Related Impairment, Sleep Quality, Sleepiness from Baseline at Week 52

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 in Fasting Insulin From Baseline at Week 52

Time frame: At Week 52

Change in Fasting Plasma Glucose (FPG) (mg/dL, mmol/L) From Baseline at Week 52

Time frame: At Week 52

Change in Hemoglobin A1c 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 Week 100

Plasma Concentration of Maridebart Cafraglutide at Week 52

Time frame: At Week 52