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

What Was Tested

In this phase 3 trial, researchers set out to test MariTide (Maridebart Cafraglutide) for sleep apnea (obstructive).

It had two arms (groups): Maridebart Cafraglutide (experimental) and Placebo (placebo comparator).

Participants will receive maridebart cafraglutide subcutaneously (SC).

Participants will receive placebo SC.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 250 planned participants were the target.

It was open to people of any sex aged from 18 years up to 99 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: had any previous or planned upper airway surgery or major ear, nose, or throat surgery for osa.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

The sleep apnea (obstructive) participants were allocated by chance, so the MariTide (Maridebart Cafraglutide) group and the comparison group should start out alike.

Groups ran in parallel: each of the sleep apnea (obstructive) participants stayed in one arm throughout.

As a double-blind MariTide (Maridebart Cafraglutide) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2025-12-19 with completion listed for 2027-08-20.

It ran at 61 sites in United States (13), Japan (9), Germany (6), Brazil (5), France (5) and Hungary (5).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Apnea-Hypopnea Index (AHI) from baseline at week 52 (time frame: At week 52).

It also tracked 28 secondary outcomes, for example Percentage Change in AHI from baseline at week 52, Participants Achieving AHI < 5 or AHI 5 to 14 with Epworth Sleepiness Scale (ESS) ≤ 10 from baseline at week 52, Percentage Change in Body Weight from baseline at week 52, Change in Sleep Apnea-specific Hypoxic Burden (SASHB) from baseline at week 52, Percentage change in High Sensitivity C-reactive Protein (hs-CRP) from baseline at week 52 and Change in Systolic Blood Pressure from baseline at week 48.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of MariTide (Maridebart Cafraglutide) in 250 people with sleep apnea (obstructive).

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the MariTide (Maridebart Cafraglutide) compound page, Sleep apnea (obstructive) research.