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

NCT07226765 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 20250002
• Study Type: interventional
• Target: 250
• Locations: 7 countries
• Sites: 34

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 not on PAP therapy and are living with overweight or obesity.

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive sleep apnea; OSA; Overweight; Obesity; Maridebart Cafraglutide; AMG 133; MariTide

Outcome Measures

Primary Outcomes (1)

• Change in Apnea-hypopnea Index (AHI) from baseline at Week 52

  At Week 52

Secondary Outcomes (8)

• Percent 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

• Percent 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 SC.

Also known as: AMG 133, MariTide

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:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (34)

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

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

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

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

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

Sleep Apnea, Obstructive; Overweight; Obesity

Condition Hierarchy (Ancestors)

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

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 6, 2025
• First Posted: November 10, 2025
• Study Start: November 25, 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 (or other new use) 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, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. 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

ES (2); DE (6); AU (3); US (13); JP (5); CA (3); CZ (2)