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

Amgen

Status and phase: Enrolling; Phase 3

Conditions: Obstructive Sleep Apnea

Treatments: Drug: Placebo; Drug: Maridebart cafraglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT07226765

20250002

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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250 participants in 2 patient groups, including a placebo group

Maridebart Cafraglutide

Experimental group

Description:

Participants will receive maridebart cafraglutide subcutaneously (SC).

Treatment:

Drug: Maridebart cafraglutide

Placebo

Placebo Comparator group

Description:

Participants will receive placebo SC.

Treatment:

Drug: Placebo