Ireland
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Active, not recruiting Phase 3

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

NCT07226765 · tracked via the Priya Life Science France tracker
Sponsor
Phase
Phase 3
Started
2025-11-25
Last updated
2026-09-29

Condition(s) studied

Obstructive Sleep Apnea

Investigational drug(s) / intervention(s)

Maridebart cafraglutide →Placebo

Maridebart cafraglutide: Participants will receive maridebart cafraglutide SC.

Placebo: Participants will receive placebo SC.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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 or major ear, nose or throat surgery for OSA. * Those with significant craniofacial abnormalities that may affect breathing at screening. * Participants diagnosed with 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 or other treatments, that in the opinion of the investigator, may interfere with study outcomes. * 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.

Primary outcome measure(s)

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

Trial sites (57)

FacilityCityRegionStatus
Valley Clinical Trials Northridge California
Peninsula Research Associates Rolling Hills Estates California
Teradan Clinical Trials Brandon Florida
Destiny Research Center Palmetto Bay Florida
Clinical Research Center Of Florida Pompano Beach Florida
NeuroTrials Research Atlanta Georgia
Basil Clinical Laurelton New York
Monroe Biomedical Research Monroe North Carolina
CTI Clinical Research Center Cincinnati Ohio
FutureSearch Trials of Neurology Austin Texas
Epic Medical Research - DeSoto DeSoto Texas
Sleep Therapy & Research Center San Antonio Texas
Northwest Clinical Research Center Bellevue Washington
Woolcock Institute of Medical Research Macquarie Park New South Wales
Royal Brisbane and Womens Hospital Herston Queensland
Monash Medical Centre Clayton Victoria
Nucleo de Pesquisa do Rio Grande do Sul Porto Alegre Rio Grande do Sul
Instituto de Pesquisa Clinica de Campinas - Ipecc Campinas São Paulo
CPQuali Pesquisa Clinica Ltda São Paulo São Paulo
Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo Hcfmusp São Paulo São Paulo
Centro Paulista de Investigacao Clinica Cepic São Paulo Brazil
CaRe Clinic Calgary Alberta
Aggarwal and Associates Ltd Brampton Ontario
Wharton Medical Clinic Hamilton Ontario
Diex Recherche Trois Rivieres Trois-Rivières Quebec
Nemocnice Rudolfa a Stefanie Benesov as Benesov U Prahy Czechia
Fakultni nemocnice Brno Brno Czechia
Cerebrovaskularni poradna sro Ostrava - Poruba Czechia
Centre Hospitalier Universitaire d'Angers Angers France
Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin Bordeaux France
Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon Grenoble France
Advanced Sleep Research Berlin Germany
InnoDiab Forschung Essen Germany
Diabeteszentrum Hamburg West Hamburg Germany
Siteworks - Zentrum fuer klinische Studien Hannover Hanover Germany
Siteworks - Zentrum fuer klinische Studien Karlsruhe Karlsruhe Germany
Red-Institut GmbH Oldenburg Germany
SomnoCenter Budapest Alvaszavar Kozpont Budapest Hungary
Debreceni Egyetem Klinikai Kozpont Debrecen Hungary
Reformatus Pulmonologiai Centrum Törökbálint Hungary

+ 17 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07226765 on ClinicalTrials.gov ↗ ← All trials in France