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

What Was Tested

This registered phase 3 trial tested 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: 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.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: individuals who have had any previous or planned upper airway surgery or major ear, nose or throat surgery for osa; active device treatment of osa or other treatments, that in the opinion of the investigator, may interfere with study outcomes.

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.

The MariTide (Maridebart Cafraglutide) group and the comparison group ran side by side rather than switching.

Neither the sleep apnea (obstructive) participants nor the staff measuring them knew who was on MariTide (Maridebart Cafraglutide), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2025-11-25 with completion listed for 2027-08-30.

It ran at 57 sites in United States (13), Japan (9), Germany (6), Brazil (5), Spain (5) and Canada (4).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Apnea-hypopnea Index (AHI) from baseline at Week 52 (time frame: At Week 52).

It also tracked 28 secondary outcomes, for example Percent 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, Percent Change in Body Weight from baseline at Week 52, Change in Sleep Apnea-specific Hypoxic Burden (SASHB) from baseline at Week 52, Percent Change in High Sensitivity C-reactive Protein (hs-CRP) from baseline at Week 52 and Change in Systolic Blood Pressure (SBP) 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.