A Master Protocol to Investigate the Efficacy and Safety of Orforglipron Once Daily in Participants Who Have Obstructive Sleep Apnea and Obesity or Overweight: A Randomized, Double-Blind, Placebo-Controlled Trial
Status: Recruiting
Location: See all (75) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
Study GZRA is a master protocol that will support 2 independent studies, GZ01 and GZ02. Participants will be assigned to the appropriate study prior to randomization. The purpose of the studies is to evaluate the efficacy and safety of orforglipron in participants who have moderate-to-severe OSA and obesity or overweight. Study GZ01 will include participants who are unable or are unwilling to use PAP therapy. Study GZ02 will include participants who are on PAP therapy for at least 3 months at time of screening and plan to continue PAP therapy during the study.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ Master GZRA inclusion criteria
• have AHI ≥15 on PSG as part of the trial at screening (V1).
• have body mass index (BMI) ≥27 kg/m²
⁃ Study 1 GZ01 inclusion criteria
• Participants who are unable or unwilling to use PAP therapy.
• Participants must not have used PAP for at least 4 weeks prior to screening.
⁃ Study 2 GZ02 inclusion criteria
• Participants who have been on PAP therapy for at least 3 consecutive months prior to study start and plan to continue PAP therapy during the study.
Locations
United States
California
Ark Clinical Research
RECRUITING
Long Beach
Peninsula Research Associates
RECRUITING
Rolling Hills Estates
Artemis Institute for Clinical Research
RECRUITING
San Diego
Colorado
Care Access - Aurora
RECRUITING
Aurora
Georgia
EBGS Clinical Research Center
RECRUITING
Snellville
Idaho
Elite Clinical Trials
RECRUITING
Blackfoot
Illinois
Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative
RECRUITING
Springfield
Louisiana
Care Access - Shreveport
RECRUITING
Shreveport
North Carolina
Accellacare - Wilmington
NOT_YET_RECRUITING
Wilmington
New Mexico
The Sleep Spot - Maimonides
RECRUITING
Albuquerque
Ohio
CTI Clinical Research Center
RECRUITING
Cincinnati
Pennsylvania
Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)
RECRUITING
Pittsburgh
Preferred Primary Care Physicians
RECRUITING
Uniontown
Texas
FutureSearch Trials of Neurology
RECRUITING
Austin
Prime Revival Research Institute, LLC
RECRUITING
Flower Mound
Washington
Northwest Clinical Research Center
RECRUITING
Bellevue
Other Locations
Argentina
Centro Médico Viamonte
RECRUITING
Buenos Aires
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
RECRUITING
Ciudad Autonoma De Buenos Aires
Consultorio de Investigación Clínica EMO SRL
RECRUITING
Ciudad Autonoma De Buenos Aires
Centro de Investigaciones Metabólicas (CINME)
RECRUITING
Ciudad Autónoma De Buenos Aires
Centro Privado de Medicina Respiratoria
RECRUITING
Paraná
Instituto Médico Río Cuarto
RECRUITING
Río Cuarto
INECO Neurociencias Oroño
RECRUITING
Rosario
Centro de Salud e Investigaciones Médicas
RECRUITING
Santa Rosa
Brazil
Núcleo de Pesquisa Clínica do Rio Grande do Sul
NOT_YET_RECRUITING
Porto Alegre
BR Trials - Ensaios Clinicos e Consultoria
NOT_YET_RECRUITING
Sao Paulo
CEPIC - Centro Paulista de Investigação Clínica
RECRUITING
São Paulo
CPQuali Pesquisa Clínica
NOT_YET_RECRUITING
São Paulo
Hospital das Clinicas FMUSP
NOT_YET_RECRUITING
São Paulo
China
Peking University People's Hospital
RECRUITING
Beijing
The First Hospital of Jilin University
NOT_YET_RECRUITING
Changchun
Sichuan Provincial People's Hospital
RECRUITING
Chengdu
The Fourth Affiliated Hospital of Harbin Medical University
NOT_YET_RECRUITING
Harbin
Huzhou Central Hospital
RECRUITING
Huzhou
The First Affiliated Hospital of Henan University of Science &Technology
RECRUITING
Luoyang Shi
Jiangxi Provincial People's Hospital
RECRUITING
Nanchang
Ningbo First Hospital
RECRUITING
Ningbo
Pudong New Area People's Hospital Shanghai
RECRUITING
Shanghai
ShenZhen People's Hospital
RECRUITING
Shenzhen
Wuxi People's Hospital
RECRUITING
Wuxi
Germany
CIMS Studienzentrum Bamberg
RECRUITING
Bamberg
Advanced Sleep Research
RECRUITING
Berlin
InnoDiab Forschung Gmbh
RECRUITING
Essen
Unterfrintroper Hausarztzentrum Klinische Forschung
NOT_YET_RECRUITING
Essen
Siteworks GmbH - Hannover
RECRUITING
Hannover
Siteworks - Karlsruhe
RECRUITING
Karlsruhe
Institut für Diabetesforschung GmbH Münster
RECRUITING
Münster
RED-Institut GmbH
RECRUITING
Oldenburg
India
SDS Tuberculosis Research Center & Rajiv Gandhi Institute of Chest Diseases
NOT_YET_RECRUITING
Bengaluru
St. Johns Medical College Hospital
NOT_YET_RECRUITING
Bengaluru
Endolife Speciality Hospitals
NOT_YET_RECRUITING
Guntur
Sleep & Snoring Clinic & Research Centre
NOT_YET_RECRUITING
Nagpur
All India Institute of Medical Sciences
NOT_YET_RECRUITING
New Delhi
Sir Ganga Ram Hospital
NOT_YET_RECRUITING
New Delhi
Villoo Poonawalla Memorial Hospital
NOT_YET_RECRUITING
Pune
All India Institute of Medical Sciences
NOT_YET_RECRUITING
Raipur
All India Institute of Medical Sciences - Rishikesh
NOT_YET_RECRUITING
Rishikesh
Bhakti Vedanta Hospital and Research Institute
NOT_YET_RECRUITING
Thane
Japan
Kirigaokatsuda Hospital
RECRUITING
Kitakyushu
Osaka Kaisei Hospital
RECRUITING
Osaka
Sakai City Medical Center
RECRUITING
Sakai
Nakamura Clinic
RECRUITING
Urasoe
RESM Respiratory and Sleep Medical Care Clinic
RECRUITING
Yokohama
Mexico
Enclifar Ensayos Clínicos Farmacológicos Sc
NOT_YET_RECRUITING
Chihuahua
Diseno y Planeacion en Investigacion Medica
NOT_YET_RECRUITING
Guadalajara
Private Practice - Dr. Arechavaleta Granell Maria del Rosario
NOT_YET_RECRUITING
Guadalajara
Centro de Investigacion en Artritis y Osteoporosis SC
NOT_YET_RECRUITING
Mexicali
Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares
RECRUITING
Mexico City
RM Pharma Specialists - Unidad Especializada en Datos
RECRUITING
Mexico City
CEINV Salud
NOT_YET_RECRUITING
Monterrey
Centro de investigación y control metabólico
NOT_YET_RECRUITING
Monterrey
Taiwan
Chiayi Christian Hospital
NOT_YET_RECRUITING
Chiayi City
China Medical University Hospital
NOT_YET_RECRUITING
Taichung
National Cheng Kung University Hospital
NOT_YET_RECRUITING
Tainan
Chang Gung Medical Foundation-Linkou Branch
RECRUITING
Taoyuan
Contact Information
Primary
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
clinical_inquiry_hub@lilly.com
1-317-615-4559
Time Frame
Start Date: 2024-10-22
Estimated Completion Date: 2027-01
Participants
Target number of participants: 600
Treatments
Experimental: Orforglipron
Participants will receive orforglipron orally.~Study 1 GZ01: Participants who are unable or unwilling to use PAP~Study 2 GZ02: Participants who plan to continue PAP therapy
Placebo_comparator: Placebo
Participants will receive placebo orally.~Study 1 GZ01: Participants who are unable or unwilling to use PAP~Study 2 GZ02: Participants who plan to continue PAP therapy
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company