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

NCT07225686 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 20230225
• Study Type: interventional
• Target: 250
• Locations: 11 countries
• Sites: 45

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

Keywords

MariTide; Maridebart Cafraglutide; AMG 133; Obesity

Outcome Measures

Primary Outcomes (1)

• Change in AHI from baseline at week 52

  At Week 52

Secondary Outcomes (8)

• Percentage Change in AHI from baseline at week 52

  At Week 52

• Participants Achieving ≥ 50% AHI Reduction from baseline at week 52

  At Week 52

• Participants Achieving AHI < 5 or AHI 5 to 14 with Epworth Sleepiness Scale (ESS) ≤ 10 from baseline at week 52

  At Week 52

• Percentage Change in Body Weight from baseline at Week 52

  At Week 52

• Change in Sleep Apnea-specific Hypoxic Burden (SASHB) from baseline at Week 52

  At Week 52

Study Arms (2)

Maridebart Cafraglutide

EXPERIMENTAL

Participants will receive maridebart cafraglutide subcutaneously (SC).

Drug: Maridebart cafraglutide

Placebo

PLACEBO COMPARATOR

Participants will receive placebo SC.

Drug: Placebo

Interventions

Maridebart cafraglutide DRUG

Participants will receive maridebart cafraglutide as SC injections.

Also known as: AMG 133

Maridebart Cafraglutide

Placebo DRUG

Participants will receive placebo SC.

Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (45)

Valley Clinical Trials

Northridge, California, 91325, United States

RECRUITING

Peninsula Research Associates

Rolling Hills Estates, California, 90274, United States

RECRUITING

Teradan Clinical Trials

Brandon, Florida, 33511, United States

RECRUITING

Destiny Research Center

Palmetto Bay, Florida, 33157, United States

RECRUITING

Clinical Research Center Of Florida

Pompano Beach, Florida, 33060, United States

RECRUITING

NeuroTrials Research

Atlanta, Georgia, 30328, United States

RECRUITING

Basil Clinical

Laurelton, New York, 11413, United States

RECRUITING

Monroe Biomedical Research

Monroe, North Carolina, 28112, United States

RECRUITING

CTI Clinical Research Center

Cincinnati, Ohio, 45212, United States

RECRUITING

FutureSearch Trials of Neurology

Austin, Texas, 78731, United States

RECRUITING

Epic Medical Research - DeSoto

DeSoto, Texas, 75115, United States

RECRUITING

Sleep Therapy & Research Center

San Antonio, Texas, 78229, United States

RECRUITING

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

RECRUITING

Woolcock Institute of Medical Research

Macquarie Park, New South Wales, 2113, Australia

RECRUITING

Royal Brisbane and Womens Hospital

Herston, Queensland, 4006, Australia

RECRUITING

Monash Medical Centre

Clayton, Victoria, 3168, Australia

RECRUITING

Nucleo de Pesquisa do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90035-170, Brazil

RECRUITING

CaRe Clinic

Calgary, Alberta, T2N 4L7, Canada

RECRUITING

Aggarwal and Associates Ltd

Brampton, Ontario, L6T 0G1, Canada

RECRUITING

Wharton Medical Clinic

Hamilton, Ontario, L8L 5G8, Canada

RECRUITING

Nemocnice Rudolfa a Stefanie Benesov as

Benesov U Prahy, 256 01, Czechia

RECRUITING

Cerebrovaskularni poradna sro

Ostrava - Poruba, 708 00, Czechia

RECRUITING

Centre Hospitalier Universitaire d'Angers

Angers, 49933, France

RECRUITING

Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin

Bordeaux, 33000, France

RECRUITING

Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon

Grenoble, 38043, France

RECRUITING

Hospices Civils de Lyon - Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

RECRUITING

Advanced Sleep Research

Berlin, 10117, Germany

RECRUITING

InnoDiab Forschung

Essen, 45136, Germany

RECRUITING

Diabeteszentrum Hamburg West

Hamburg, 22607, Germany

RECRUITING

Siteworks - Zentrum fuer klinische Studien Hannover

Hanover, 30449, Germany

RECRUITING

Siteworks - Zentrum fuer klinische Studien Karlsruhe

Karlsruhe, 76137, Germany

RECRUITING

Red-Institut GmbH

Oldenburg, 23758, Germany

RECRUITING

SomnoCenter Budapest Alvaszavar Kozpont

Budapest, 1012, Hungary

RECRUITING

Debreceni Egyetem Klinikai Kozpont

Debrecen, 4032, Hungary

RECRUITING

Erzsebet Gondozohaz

Gödöllő, 2100, Hungary

RECRUITING

SomnoCenter Szeged Alvaszavar Kozpont

Szeged, 6720, Hungary

RECRUITING

Reformatus Pulmonologiai Centrum

Törökbálint, 2045, Hungary

RECRUITING

Saiseikai Futsukaichi Hospital

Chikushino-shi, Fukuoka, 818-8516, Japan

RECRUITING

Fukuoka University Hospital

Fukuoka, Fukuoka, 814-0180, Japan

RECRUITING

Social Medical Corporation Sokujinkai Sleep and Mental Clinic Kitahiroshima

Kitahiroshima-shi, Hokkaido, 061-1121, Japan

RECRUITING

Kuwamizu Hospital

Kumamoto, Kumamoto, 862-0954, Japan

RECRUITING

Nakamura Clinic

Urasoe-shi, Okinawa, 901-2132, Japan

RECRUITING

Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy

Warsaw, 04-635, Poland

RECRUITING

Centro Medico Teknon

Barcelona, Catalonia, 08022, Spain

RECRUITING

Hospital Medico Quirurgico San Rafael

A Coruña, Galicia, 15006, Spain

RECRUITING

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Obesity; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Central Study Contacts

Amgen Call Center

CONTACT

866-572-6436; medinfo@amgen.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2025
• First Posted: November 10, 2025
• Study Start: December 19, 2025
• Primary Completion (Estimated): September 29, 2027
• Study Completion (Estimated): September 13, 2028
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

DE (6); AU (3); BR (1); HU (5); FR (4); US (13); JP (5); CA (3); PL (1); CZ (2); ES (2)