A Master Protocol for Orforglipron in Participants With Obstructive Sleep Apnea and Obesity or Overweight
- Registration Number
- NCT06649045
- Lead Sponsor
- Eli Lilly and Company
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
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.
Master GZRA exclusion criteria
- Have Type 1 diabetes (T1D) or Type 2 diabetes (T2D), history of ketoacidosis, or hyperosmolar state/coma
- Have HbA1c ≥6.5% (≥ 48 mmol/mol), as determined by the central laboratory at Visit 1.
- Had any previous or planned upper airway surgery for sleep apnea or major ear, nose or throat surgery
- Have diagnosis of Central or Mixed Sleep Apnea with % of mixed or central apneas/hypopneas ≥50%, or diagnosis of Cheyne Stokes Respiration
- Diagnosis of Obesity Hypoventilation Syndrome or daytime hypercapnia.
- Active device treatment of OSA other than PAP therapy
- Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator.
- Have a self-reported change in body weight >5 kg within 3 months prior to screening
- Have a prior or planned surgical treatment for obesity (excluding liposuction, abdominoplasty or cryolipolysis if performed more than 1 year prior to screening)
- Have a prior or planned endoscopic and/or present device-based therapy for obesity.
- Have obesity induced by other endocrinologic disorders or diagnosed monogenetic or syndromic forms of obesity.
Study 2 GZ02 exclusion criteria
- Have personal or job-related responsibilities, or in the opinion of the investigator have any situation that would make it unsafe to stop PAP therapy for 7 days prior to PSG testing during the study.
- Are unwilling to temporary discontinue PAP therapy for 7 days prior to PSG testing during the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Orforglipron 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 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
- Primary Outcome Measures
Name Time Method Change from Baseline in Apnea-Hypopnea Index (AHI) Baseline to Week 52
- Secondary Outcome Measures
Name Time Method Percent Change from Baseline in AHI Baseline to Week 52 Change from Baseline in Sleep Apnea-Specific Hypoxic Burden (SASHB) (% min/hour) Baseline to Week 52 Change from Baseline in Patient-Reported Outcome Measurement Information System (PROMIS) Short Form Sleep-Related Impairment 8a T-score Baseline to Week 52 Percentage of Participants Achieving ≥50% AHI Reduction Baseline to Week 52 Percent of Participants with AHI<5 or with AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤10 Baseline to Week 52 Percent Change from Baseline in Body Weight Baseline to Week 52 Change from Baseline in high-sensitivity C reactive protein (hsCRP) Concentration Baseline to Week 52
Trial Locations
- Locations (141)
Sakai City Medical Center
🇯🇵Sakai, Osaka, Japan
Osaka Kaisei Hospital
🇯🇵Osaka, Japan
Huzhou Central Hospital
🇨🇳Huzhou, Zhejiang, China
Ningbo First Hospital
🇨🇳Ningbo, Zhejiang, China
Ark Clinical Research
🇺🇸Long Beach, California, United States
Peninsula Research Associates
🇺🇸Rolling Hills Estates, California, United States
Artemis Institute for Clinical Research
🇺🇸San Diego, California, United States
Care Access - Aurora
🇺🇸Aurora, Colorado, United States
EBGS Clinical Research Center
🇺🇸Snellville, Georgia, United States
Elite Clinical Trials
🇺🇸Blackfoot, Idaho, United States
Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative
🇺🇸Springfield, Illinois, United States
Care Access - Shreveport
🇺🇸Shreveport, Louisiana, United States
The Sleep Spot - Maimonides
🇺🇸Albuquerque, New Mexico, United States
Accellacare - Wilmington
🇺🇸Wilmington, North Carolina, United States
CTI Clinical Research Center
🇺🇸Cincinnati, Ohio, United States
Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)
🇺🇸Pittsburgh, Pennsylvania, United States
Preferred Primary Care Physicians
🇺🇸Uniontown, Pennsylvania, United States
FutureSearch Trials of Neurology
🇺🇸Austin, Texas, United States
Prime Revival Research Institute, LLC
🇺🇸Flower Mound, Texas, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Centro Médico Viamonte
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Nakamura Clinic
🇯🇵Urasoe, Okinawa, Japan
Consultorio de Investigación Clínica EMO SRL
🇦🇷Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
🇦🇷Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Instituto Médico Río Cuarto
🇦🇷Río Cuarto, Córdoba, Argentina
Centro Privado de Medicina Respiratoria
🇦🇷Paraná, Entre Ríos, Argentina
Centro de Salud e Investigaciones Médicas
🇦🇷Santa Rosa, La Pampa, Argentina
Centro de Investigaciones Metabólicas (CINME)
🇦🇷Ciudad Autónoma de Buenos Aires, Argentina
Núcleo de Pesquisa Clínica do Rio Grande do Sul
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
BR Trials - Ensaios Clinicos e Consultoria
🇧🇷Sao Paulo, São Paulo, Brazil
CPQuali Pesquisa Clínica
🇧🇷São Paulo, Brazil
Hospital das Clinicas FMUSP
🇧🇷São Paulo, Brazil
Peking University People's Hospital
🇨🇳Beijing, Beijing, China
The Fourth Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
The First Affiliated Hospital of Henan University of Science &Technology
🇨🇳Luoyang Shi, Henan, China
Wuxi People's Hospital
🇨🇳Wuxi, Jiangsu, China
Jiangxi Provincial People's Hospital
🇨🇳Nanchang, Jiangxi, China
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Pudong New Area People's Hospital Shanghai
🇨🇳Shanghai, Shanghai, China
Sichuan Provincial People's Hospital
🇨🇳Chengdu, Sichuan, China
Unterfrintroper Hausarztzentrum Klinische Forschung
🇩🇪Essen, Nordrhein-Westfalen, Germany
Endolife Speciality Hospitals
🇮🇳Guntur, Andhra Pradesh, India
All India Institute of Medical Sciences
🇮🇳New Delhi, Delhi, India
Sir Ganga Ram Hospital
🇮🇳New Delhi, Delhi, India
SDS Tuberculosis Research Center & Rajiv Gandhi Institute of Chest Diseases
🇮🇳Bengaluru, Karnataka, India
St. Johns Medical College Hospital
🇮🇳Bengaluru, Karnataka, India
Sleep & Snoring Clinic & Research Centre
🇮🇳Nagpur, Maharashtra, India
Villoo Poonawalla Memorial Hospital
🇮🇳Pune, Maharashtra, India
Bhakti Vedanta Hospital and Research Institute
🇮🇳Thane, Maharashtra, India
All India Institute of Medical Sciences - Rishikesh
🇮🇳Rishikesh, Uttarakhand, India
Kirigaokatsuda Hospital
🇯🇵Kitakyushu, Fukuoka, Japan
RESM Respiratory and Sleep Medical Care Clinic
🇯🇵Yokohama, Kanagawa, Japan
Centro de Investigacion en Artritis y Osteoporosis SC
🇲🇽Mexicali, Baja California, Mexico
RM Pharma Specialists - Unidad Especializada en Datos
🇲🇽Mexico City, Distrito Federal, Mexico
Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares
🇲🇽Mexico City, Distrito Federal, Mexico
Diseno y Planeacion en Investigacion Medica
🇲🇽Guadalajara, Jalisco, Mexico
Private Practice - Dr. Arechavaleta Granell Maria del Rosario
🇲🇽Guadalajara, Jalisco, Mexico
CEINV Salud
🇲🇽Monterrey, Nuevo León, Mexico
Centro de investigación y control metabólico
🇲🇽Monterrey, Nuevo León, Mexico
Enclifar Ensayos Clínicos Farmacológicos Sc
🇲🇽Chihuahua, Mexico
Chiayi Christian Hospital
🇨🇳Chiayi City, Chiayi, Taiwan
China Medical University Hospital
🇨🇳Taichung, Taiwan
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
Chang Gung Medical Foundation-Linkou Branch
🇨🇳Taoyuan, Taiwan
Ark Clinical Research
🇺🇸Long Beach, California, United States
CTI Clinical Research Center
🇺🇸Cincinnati, Ohio, United States
Peninsula Research Associates
🇺🇸Rolling Hills Estates, California, United States
Artemis Institute for Clinical Research
🇺🇸San Diego, California, United States
Care Access - Aurora
🇺🇸Aurora, Colorado, United States
EBGS Clinical Research Center
🇺🇸Snellville, Georgia, United States
Elite Clinical Trials
🇺🇸Blackfoot, Idaho, United States
Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative
🇺🇸Springfield, Illinois, United States
Care Access - Shreveport
🇺🇸Shreveport, Louisiana, United States
The Sleep Spot - Maimonides
🇺🇸Albuquerque, New Mexico, United States
Accellacare - Wilmington
🇺🇸Wilmington, North Carolina, United States
Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)
🇺🇸Pittsburgh, Pennsylvania, United States
Preferred Primary Care Physicians
🇺🇸Uniontown, Pennsylvania, United States
FutureSearch Trials of Neurology
🇺🇸Austin, Texas, United States
Prime Revival Research Institute, LLC
🇺🇸Flower Mound, Texas, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Centro Médico Viamonte
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Consultorio de Investigación Clínica EMO SRL
🇦🇷Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
🇦🇷Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Centro Privado de Medicina Respiratoria
🇦🇷Paraná, Entre Ríos, Argentina
Centro de Salud e Investigaciones Médicas
🇦🇷Santa Rosa, La Pampa, Argentina
INECO Neurociencias Oroño
🇦🇷Rosario, Santa Fe, Argentina
Centro de Investigaciones Metabólicas (CINME)
🇦🇷Ciudad Autónoma de Buenos Aires, Argentina
Instituto Médico Río Cuarto
🇦🇷Río Cuarto, Córdoba, Argentina
ShenZhen People's Hospital
🇨🇳Shenzhen, Guangdong, China
The Fourth Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
The First Affiliated Hospital of Henan University of Science &Technology
🇨🇳Luoyang Shi, Henan, China
Wuxi People's Hospital
🇨🇳Wuxi, Jiangsu, China
Núcleo de Pesquisa Clínica do Rio Grande do Sul
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
BR Trials - Ensaios Clinicos e Consultoria
🇧🇷Sao Paulo, São Paulo, Brazil
CPQuali Pesquisa Clínica
🇧🇷São Paulo, Brazil
CEPIC - Centro Paulista de Investigação Clínica
🇧🇷São Paulo, Brazil
Hospital das Clinicas FMUSP
🇧🇷São Paulo, Brazil
Peking University People's Hospital
🇨🇳Beijing, Beijing, China
Jiangxi Provincial People's Hospital
🇨🇳Nanchang, Jiangxi, China
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Pudong New Area People's Hospital Shanghai
🇨🇳Shanghai, Shanghai, China
Sichuan Provincial People's Hospital
🇨🇳Chengdu, Sichuan, China
Huzhou Central Hospital
🇨🇳Huzhou, Zhejiang, China
Ningbo First Hospital
🇨🇳Ningbo, Zhejiang, China
Nemocnice Rudolfa a Stefanie Benešov
🇨🇿Benesov, Benešov, Czechia
Milan Kvapil s.r.o., Diabetologicka ambulance
🇨🇿Praha, Praha 4, Czechia
Endolife Speciality Hospitals
🇮🇳Guntur, Andhra Pradesh, India
All India Institute of Medical Sciences
🇮🇳New Delhi, Delhi, India
Sir Ganga Ram Hospital
🇮🇳New Delhi, Delhi, India
Praglandia s.r.o
🇨🇿Praha 5, Czechia
Siteworks - Karlsruhe
🇩🇪Karlsruhe, Baden-Württemberg, Germany
CIMS Studienzentrum Bamberg
🇩🇪Bamberg, Bayern, Germany
Siteworks GmbH - Hannover
🇩🇪Hannover, Niedersachsen, Germany
InnoDiab Forschung Gmbh
🇩🇪Essen, Nordrhein-Westfalen, Germany
Unterfrintroper Hausarztzentrum Klinische Forschung
🇩🇪Essen, Nordrhein-Westfalen, Germany
Institut für Diabetesforschung GmbH Münster
🇩🇪Münster, Nordrhein-Westfalen, Germany
RED-Institut GmbH
🇩🇪Oldenburg, Schleswig-Holstein, Germany
Advanced Sleep Research
🇩🇪Berlin, Germany
SDS Tuberculosis Research Center & Rajiv Gandhi Institute of Chest Diseases
🇮🇳Bengaluru, Karnataka, India
St. Johns Medical College Hospital
🇮🇳Bengaluru, Karnataka, India
Sleep & Snoring Clinic & Research Centre
🇮🇳Nagpur, Maharashtra, India
Villoo Poonawalla Memorial Hospital
🇮🇳Pune, Maharashtra, India
Bhakti Vedanta Hospital and Research Institute
🇮🇳Thane, Maharashtra, India
All India Institute of Medical Sciences - Rishikesh
🇮🇳Rishikesh, Uttarakhand, India
Kirigaokatsuda Hospital
🇯🇵Kitakyushu, Fukuoka, Japan
RESM Respiratory and Sleep Medical Care Clinic
🇯🇵Yokohama, Kanagawa, Japan
Nakamura Clinic
🇯🇵Urasoe, Okinawa, Japan
Sakai City Medical Center
🇯🇵Sakai, Osaka, Japan
Osaka Kaisei Hospital
🇯🇵Osaka, Japan
Centro de investigación y control metabólico
🇲🇽Monterrey, Nuevo León, Mexico
Enclifar Ensayos Clínicos Farmacológicos Sc
🇲🇽Chihuahua, Mexico
Chiayi Christian Hospital
🇨🇳Chiayi City, Chiayi, Taiwan
China Medical University Hospital
🇨🇳Taichung, Taiwan
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
Chang Gung Medical Foundation-Linkou Branch
🇨🇳Taoyuan, Taiwan
Centro de Investigacion en Artritis y Osteoporosis SC
🇲🇽Mexicali, Baja California, Mexico
RM Pharma Specialists - Unidad Especializada en Datos
🇲🇽Mexico City, Distrito Federal, Mexico
Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares
🇲🇽Mexico City, Distrito Federal, Mexico
Diseno y Planeacion en Investigacion Medica
🇲🇽Guadalajara, Jalisco, Mexico
Private Practice - Dr. Arechavaleta Granell Maria del Rosario
🇲🇽Guadalajara, Jalisco, Mexico
CEINV Salud
🇲🇽Monterrey, Nuevo León, Mexico