MARITIME-OSA-1

RecruitingPhase 3

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

A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy and Living With Overweight or Obesity

Lead sponsor

Amgen

Asset

Maridebart cafraglutide / MariTide

Subcutaneous · GLP-1 agonist / GIP antagonist

Listed sites

Recruiting sites

Enrollment

250

estimated

Study population

Obesity / overweight, Sleep apnea

Key I/E criterion

•BMI ≥27

Primary endpoint

•AHI, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07225686

Org study ID20230225

Timeline

Milestones

Study first posted2025-11-10actual

Study start2025-12-19actual

Last update posted2026-05-22actual

Primary completion2027-09-29estimated

Study completion2028-09-13estimated

Assets

Investigational agents

Maridebart cafraglutide / MariTide

Study populations

Who this study enrolls

Obesity / overweightSleep apnea

Eligibility

Who can enroll

Minimum age18 Years

Maximum age99 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (9)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes

Cardiometabolic biomarkers

Weight & body composition

Patient-reported / QoL

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Percentage Change in Body Weight from baseline at Week 52

Time frame:At Week 52

Body weight, % change

percent change from baseline, improvement

Cardiometabolic biomarkers

2 endpoints

Secondary/protocol endpoint

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

Time frame:At Week 52

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

Change in Systolic Blood Pressure from baseline at Week 48

Time frame:At Week 48

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

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 from baseline, improvement

Other clinical outcomes

5 endpoints

Primary/protocol endpoint

Change in AHI from baseline at week 52

Time frame:At Week 52

AHI, change

change from baseline, improvement

Secondary/protocol endpoint

Percentage Change in AHI from baseline at week 52

Time frame:At Week 52

AHI, change

percent change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:At Week 52

OSA responder

threshold achievement, improvement

Secondary/protocol endpoint

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

OSA responder

threshold achievement, improvement

Secondary/protocol endpoint

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

Time frame:At Week 52

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.