Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy (MARITIME-OSA-1)

Amgen

Status and phase: Begins enrollment this month; Phase 3

Conditions: Obesity; Obstructive Sleep Apnea

Treatments: Drug: Placebo; Drug: Maridebart cafraglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT07225686

20230225

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 receiving positive airway pressure (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

• 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.

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