Recruiting
Phase 3

Maridebart Cafraglutide

Sponsor:

Amgen

Code:

NCT07225686

Conditions

Obesity

Obstructive Sleep Apnea

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Maridebart cafraglutide

Placebo

Study Details

Brief summary:

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.

Conditions

Obesity

Obstructive Sleep Apnea

Study ID

NCT07225686

Start date

Dec 19, 2025

Status verified date

Jul, 2026

Completion date

Sep 13, 2028

Anticipated

Primary completion date

Sep 29, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 or major ear, nose, or throat surgery for OSA.
  • Significant craniofacial abnormalities that may affect breathing at screening.
  • Diagnosis of Central or Mixed Sleep Apnea with proportion of mixed or central apneas/hypopneas ≥ 50%, and/or diagnosis of Cheyne Stokes Respiration.
  • Active device treatment of OSA other than PAP therapy (eg, oral appliances), or other treatments, that in the opinion of the investigator, may interfere with study outcomes.
  • 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.

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Maridebart Cafraglutide

Participants will receive maridebart cafraglutide subcutaneously (SC).

placebo comparator: Placebo

Participants will receive placebo SC.

Interventions

Maridebart cafraglutide

Participants will receive maridebart cafraglutide as SC injections.

Placebo

Participants will receive placebo SC.

Primary outcome measure

  • Change in Apnea-Hypopnea Index (AHI) from baseline at week 52 [ Time Frame: At week 52 ]

Central Contacts and Locations

Central contacts

Amgen Call Center

866-572-6436medinfo@amgen.com

Locations

Valley Clinical Trials

Recruiting

Northridge, California, United States, 91325

Peninsula Research Associates

Recruiting

Rolling Hills Estates, California, United States, 90274

Teradan Clinical Trials

Recruiting

Brandon, Florida, United States, 33511

Destiny Research Center

Recruiting

Palmetto Bay, Florida, United States, 33157

Clinical Research Center Of Florida

Recruiting

Pompano Beach, Florida, United States, 33060

NeuroTrials Research

Recruiting

Atlanta, Georgia, United States, 30328

Basil Clinical

Recruiting

Laurelton, New York, United States, 11413

Monroe Biomedical Research

Recruiting

Monroe, North Carolina, United States, 28112

CTI Clinical Research Center

Recruiting

Cincinnati, Ohio, United States, 45212

FutureSearch Trials of Neurology

Recruiting

Austin, Texas, United States, 78731

Epic Medical Research - DeSoto

Recruiting

DeSoto, Texas, United States, 75115

Sleep Therapy & Research Center

Recruiting

San Antonio, Texas, United States, 78229

Northwest Clinical Research Center

Recruiting

Bellevue, Washington, United States, 98007

CaRe Clinic

Recruiting

Calgary, Alberta, Canada, T2N 4L7

Aggarwal and Associates Ltd

Recruiting

Brampton, Ontario, Canada, L6T 0G1

Wharton Medical Clinic

Recruiting

Hamilton, Ontario, Canada, L8L 5G8

Diex Recherche Trois Rivieres

Recruiting

Trois-Rivières, Quebec, Canada, G9A 4P3

More Information

Sponsor

Amgen

Last update posted

Aug 4, 2026

Last verified

Jul, 2026

Keywords

  • MariTide
  • Maridebart Cafraglutide
  • AMG 133
  • Obesity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Amgen on 2026-08-04.