MARITIME-OSA-2

RecruitingPhase 3

Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) 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 Not on Positive Airway Pressure Therapy and Living With Overweight or Obesity (MARITIME-OSA-2)

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

—

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 IDNCT07226765

Org study ID20250002

Timeline

Milestones

Study first posted2025-11-10actual

Study start2025-11-25actual

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

•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 for sleep apnea or major ear, nose, or throat surgery.

•Those with significant craniofacial abnormalities that may affect breathing at screening.

•Participants diagnosed with Central Apnea with a percentage of central apneas/hypopneas of 50% or more, or those diagnosed with Cheyne Stokes Respiration.

•Active device treatment of OSA (eg, PAP, oral appliances), or other treatments, that in the opinion of the investigator, may interfere with study outcomes, unless willing to stop treatment at screening and throughout the study.

•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.

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

Percent 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 (SBP) 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 Apnea-hypopnea Index (AHI) from baseline at Week 52

Time frame:At Week 52

AHI, change

change from baseline, improvement

Secondary/protocol endpoint

Percent 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

componentsAHI, change, PGI, change

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.