A Master Protocol to Investigate the Efficacy and Safety of Tirzepatide Once Weekly in Participants Who Have Obstructive Sleep Apnea and Obesity: A Randomized, Double-Blind, Placebo-Controlled Trial
Status: Completed
Location: See all (56) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to evaluate the effect and safety of tirzepatide in participants with moderate to severe obstructive sleep apnea and obesity who are both unwilling or unable to use Positive Airway Pressure (PAP) therapy in GPI1 and those who are and plan to stay on PAP therapy in GPI2.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ For GPI1 Participants:
• Participants who are unable or unwilling to use PAP therapy. Participants must not have used PAP for at least 4 weeks prior to screening.
⁃ For GPI2 Participants:
• Have been on PAP therapy for at least 3 consecutive months prior to screening and plan to continue PAP therapy during the study
⁃ For Both GPI1 and GPI2 Participants:
• Have an AHI ≥15 on PSG as part of the trial at screening
• Have a body mass index (BMI) ≥30 kilogram/square meter (kg/m²)
• Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight
Locations
United States
California
Artemis Institute for Clinical Research
Riverside
Florida
Teradan Clinical Trials, LLC
Brandon
Renstar Medical Research
Ocala
Palm Beach Research Center
West Palm Beach
Georgia
NeuroTrials Research Inc
Atlanta
Idaho
Rocky Mountain Clinical Research
Idaho Falls
Indiana
Brengle Family Medicine
Indianapolis
North Dakota
Lillestol Research
Fargo
Ohio
NeuroScience Research Center
Canton
CTI-CRC
Cincinnati
Pennsylvania
Office 18
Pittsburgh
Preferred Primary Care Physicians
Uniontown
Texas
FutureSearch Trials of Neurology
Austin
Gadolin Research
Beaumont
Advanced Neuro Research Center - ANRC
El Paso
Epic Medical Research
Red Oak
Sleep Therapy Research Center
San Antonio
Washington
Rainier Clinical Research Center
Renton
Other Locations
Australia
Flinders University
Bedford Park
Woolcock Institute of Medical Research
Sydney
Brazil
Núcleo de Pesquisa Clínica do Rio Grande do Sul
Porto Alegre
CPCLIN
Sao Paulo
BR Trials - Ensaios Clinicos e Consultoria
São Paulo
CPQuali Pesquisa Clínica
São Paulo
Hospital das Clinicas FMUSP
São Paulo
Hospital das Clinicas FMUSP
São Paulo
China
The First Hospital of Jilin University
Changchun
West China Hospital, Sichuan University
Chengdu
The Second Affiliated Hospital of Nanjing Medical University
Nanjing
Zhongshan Hospital,Fudan University
Shanghai
Tianjin Medical University General Hospital
Tianjin
Wuxi People's Hospital
Wuxi
Germany
Advanced Sleep Research
Berlin
InnoDiab Forschung Gmbh
Essen
Diabeteszentrum Hamburg West
Hamburg
Siteworks GmbH
Hannover
Institut für Diabetesforschung GmbH Münster
Münster
RED-Institut GmbH
Oldenburg
Lungenpraxis Schleswig
Schleswig
Japan
Fukuwa Clinic
Chuo-ku
Kirigaokatsuda Hospital
Kitakyushu
Koujunkai Daido Clinic
Nagoya
Osaka Kaisei Hospital
Osaka
Sakai City Medical Center
Sakai
RESM Respiratory and Sleep Medical Care Clinic
Yokohama
Mexico
Investigacion En Salud Y Metabolismo Sc
Chihuahua
Private Practice - Dr. Arechavaleta Granell Maria del Rosario
Guadalajara
Unidad de Investigación Clínica y Atención Médica HEPA
Guadalajara
Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares
Mexico City
RM Pharma Specialists
Mexico City
Servicios Integrales Nova de Monterrey S.A. de C.V.
San Nicolas De Los Garza
Unidad Médica para la Salud Integral
San Nicolás De Los Garza
Arké SMO S.A de C.V
Veracruz
Puerto Rico
Puerto Rico Medical Research Center
Hato Rey
Taiwan
China Medical University Hospital
Taichung
National Cheng Kung University Hospital
Tainan
Time Frame
Start Date: 2022-06-21
Completion Date: 2024-03-29
Participants
Target number of participants: 469
Treatments
Experimental: Tirzepatide MTD_GPI1
Participants not on positive airway pressure (PAP) therapy received a maximum tolerated dose (MTD) of 10 milligrams (mg) or 15 mg of Tirzepatide once weekly (QW) as a subcutaneous (SC) injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks
Placebo_comparator: Placebo_GPI1
Participants not on PAP therapy received placebo QW as an SC injection for 52 weeks.
Experimental: Tirzepatide MTD_GPI2
Participants who are on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks
Placebo_comparator: Placebo_GPI2
Participants who are on PAP therapy received placebo QW as an SC injection for 52 weeks.
Authors
Yasushi Fukushima, James Michael Andry, Ronald Brazg, James Paul Maynard, John Douglas Hudson, Stacey Layle, Bryce A. Palchick, Haresh Boghara, Raj Karunakara, Daniel G. Lorch, Mira Baron, Carl D Vance, Blair Brengle, Ryan S Drake, Jack Bailey Vu, Paul A. Hartley, Jens Aberle, Stefan Blaas, Ludger Rose, Katharina Lederer, Michael J Lillestol, Ryutaro Shirahama, Yoshimitsu Yamasaki, Iwao Gohma, Liang-Wen Hang, Cintia Cercato, Denise Reis Franco, Bruno Halpern, Lixin Guo, Arihiro Kiyosue, Tetsuya Kawano, Yibing Lu, Danny J. Eckert, Mitsutaka Taniguchi, Lan Xu, Luis Henrique Canani, zhenmei an, Ron Grunstein, guixia wang
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company