Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure 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 on Positive Airway Pressure Therapy and Living With Overweight or Obesity

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 receiving positive airway pressure (PAP) therapy and are living with overweight or obesity.

Interventions

• Drug Maridebart cafraglutide
  Participants will receive maridebart cafraglutide as SC injections.
• 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 (12)

• Percentage 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]
• Percentage 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]
• Percentage change in High Sensitivity C-reactive Protein (hs-CRP) from baseline at week 52 [Time frame: At week 52]
• Change in Systolic Blood Pressure 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]
• Change in AHI from baseline at week 24 [Time frame: At week 24]
• Percentage change in AHI from baseline at week 24 [Time frame: At week 24]
• Change in SASHB from baseline at week 24 [Time frame: At week 24]
• Change in ESS score from baseline at week 52 [Time frame: At week 52]

Eligibility criteria

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.

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

Brazil · 5 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
• Centro Paulista de Investigacao Clinica Cepic — São Paulo

France · 5 centers

• Centre Hospitalier Universitaire d'Angers — Angers
• Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin — Bordeaux
• Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon — Grenoble
• Centre Hospitalier Universitaire de Montpellier - Hôpital Arnaud de Villeneuve — Montpellier
• Hospices Civils de Lyon - Centre Hospitalier Lyon Sud — Pierre-Bénite

Hungary · 5 centers

• SomnoCenter Budapest Alvaszavar Kozpont — Budapest
• Debreceni Egyetem Klinikai Kozpont — Debrecen
• Erzsebet Gondozohaz — Gödöllő
• SomnoCenter Szeged Alvaszavar Kozpont — Szeged
• Reformatus Pulmonologiai Centrum — Törökbálint

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

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

Poland · 3 centers

• Uniwersytecki Szpital Kliniczny w Bialymstoku — Bialystok
• Uniwersytecki Szpital Kliniczny w Poznaniu — Poznan
• Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy — Warsaw

Identifiers

NCT: NCT07225686 · 20230225

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗