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

Official title

A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure Therapy and Living With Overweight or Obesity (MARITIME-OSA-2)

Overview

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.

Interventions

• Drug Maridebart cafraglutide
  Participants will receive maridebart cafraglutide SC.
• Drug Placebo
  Participants will receive placebo SC.

Primary outcome measures

• Change in Apnea-hypopnea Index (AHI) from baseline at Week 52 [Time frame: At Week 52]

Secondary outcome measures (8)

• Percent Change in AHI from baseline at Week 52 [Time frame: At Week 52]
• Participants Achieving ≥ 50% AHI Reduction from baseline at Week 52 [Time frame: At Week 52]
• Participants Achieving AHI < 5 or AHI 5 to 14 with Epworth Sleepiness Scale (ESS) ≤ 10 from baseline at Week 52 [Time frame: At Week 52]
• Percent Change in Body Weight from baseline at Week 52 [Time frame: At Week 52]
• Change in Sleep Apnea-specific Hypoxic Burden (SASHB) from baseline at Week 52 [Time frame: At Week 52]
• Change in High Sensitivity C-reactive Protein (hs-CRP) from baseline at Week 52 [Time frame: At Week 52]
• Change in Systolic Blood Pressure (SBP) from baseline at Week 48 [Time frame: At Week 48]
• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Sleep-related Impairment 8a Score from baseline at Week 52 [Time frame: At Week 52]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 13 centers

• Valley Clinical Trials — Northridge
• Peninsula Research Associates — Rolling Hills Estates
• Teradan Clinical Trials — Brandon
• Destiny Research Center — Palmetto Bay
• Clinical Research Center Of Florida — Pompano Beach
• NeuroTrials Research — Atlanta
• Basil Clinical — Laurelton
• Monroe Biomedical Research — Monroe
• … and 5 more centers

Japan · 9 centers

• Saiseikai Futsukaichi Hospital — Chikushino-shi
• Fukuoka University Hospital — Fukuoka
• Mazda Hospital of Mazda Motor Corporation — Aki-gun
• Sleep and Mental Clinic-Kitahiroshima — Kitahiroshima-shi
• RESM ShinYokohama Sleep and Respiratory Medical Care Clinic — Yokohama
• Kuwamizu Hospital — Kumamoto
• Nakamura Clinic — Urasoe-shi
• Gokeikai Osaka Kaisei Hospital — Osaka
• … and 1 more center

Germany · 6 centers

• Advanced Sleep Research — Berlin
• InnoDiab Forschung — Essen
• Diabeteszentrum Hamburg West — Hamburg
• Siteworks - Zentrum fuer klinische Studien Hannover — Hanover
• Siteworks - Zentrum fuer klinische Studien Karlsruhe — Karlsruhe
• Red-Institut GmbH — Oldenburg

Spain · 5 centers

• Centro Medico Teknon — Barcelona
• Hospital Universitari Vall d Hebron — Barcelona
• Hospital Medico Quirurgico San Rafael — A Coruña
• Hospital Quiron Madrid — Pozuelo de Alarcón
• Hospital Universitario 12 de Octubre — Madrid

Brazil · 4 centers

• Nucleo de Pesquisa do Rio Grande do Sul — Porto Alegre
• Instituto de Pesquisa Clinica de Campinas - Ipecc — Campinas
• CPQuali Pesquisa Clinica Ltda — São Paulo
• Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo Hcfmusp — São Paulo

Canada · 4 centers

• CaRe Clinic — Calgary
• Aggarwal and Associates Ltd — Brampton
• Wharton Medical Clinic — Hamilton
• Diex Recherche Trois Rivieres — Trois-Rivières

Australia · 3 centers

• Woolcock Institute of Medical Research — Macquarie Park
• Royal Brisbane and Womens Hospital — Herston
• Monash Medical Centre — Clayton

Czechia · 3 centers

• Nemocnice Rudolfa a Stefanie Benesov as — Benesov U Prahy
• Fakultni nemocnice Brno — Brno
• Cerebrovaskularni poradna sro — Ostrava - Poruba

France · 3 centers

• Centre Hospitalier Universitaire d'Angers — Angers
• Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin — Bordeaux
• Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon — Grenoble

Hungary · 3 centers

• SomnoCenter Budapest Alvaszavar Kozpont — Budapest
• Debreceni Egyetem Klinikai Kozpont — Debrecen
• Reformatus Pulmonologiai Centrum — Törökbálint

Poland · 1 center

• Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy — Warsaw

Identifiers

NCT: NCT07226765 · 20250002

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗