A Master Protocol for Orforglipron in Participants With Obstructive Sleep Apnea and Obesity or Overweight
NCT ID: NCT06649045
Last Updated: 2025-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
600 participants
INTERVENTIONAL
2024-10-22
2027-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
Orforglipron
Administered orally.
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
Placebo
Administered orally.
Interventions
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Orforglipron
Administered orally.
Placebo
Administered orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* have body mass index (BMI) ≥27 kg/m²
* Participants who are unable or unwilling to use PAP therapy.
* Participants must not have used PAP for at least 4 weeks prior to screening.
* 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.
Exclusion Criteria
* 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.
* 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.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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
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 de Investigaciones Metabólicas (CINME)
Buenos Aires, , Argentina
Centro Médico Viamonte
Buenos Aires, , Argentina
Consultorio de Investigación Clínica EMO SRL
Buenos Aires, , Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires, , Argentina
Centro Privado de Medicina Respiratoria
Paraná, , Argentina
Instituto Médico Río Cuarto
Río Cuarto, , Argentina
INECO Neurociencias Oroño
Rosario, , Argentina
Centro de Salud e Investigaciones Médicas
Santa Rosa, , Argentina
Núcleo de Pesquisa Clínica do Rio Grande do Sul
Porto Alegre, , Brazil
CPQuali Pesquisa Clínica
São Paulo, , Brazil
BR Trials - Ensaios Clinicos e Consultoria
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, , China
The First Hospital of Jilin University
Changchun, , China
Sichuan Provincial People's Hospital
Chengdu, , China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, , China
Huzhou Central Hospital
Huzhou, , China
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang Shi, , China
Jiangxi Provincial People's Hospital
Nanchang, , China
Ningbo First Hospital
Ningbo, , China
Pudong New Area People's Hospital Shanghai
Shanghai, , China
ShenZhen People's Hospital
Shenzhen, , China
Wuxi People's Hospital
Wuxi, , China
Nemocnice Rudolfa a Stefanie Benešov
Benešov, , Czechia
Milan Kvapil s.r.o., Diabetologicka ambulance
Prague, , Czechia
Praglandia s.r.o
Prague, , Czechia
CIMS Studienzentrum Bamberg
Bamberg, , Germany
Advanced Sleep Research
Berlin, , Germany
InnoDiab Forschung Gmbh
Essen, , Germany
Unterfrintroper Hausarztzentrum Klinische Forschung
Essen, , Germany
Siteworks GmbH - Hannover
Hanover, , Germany
Siteworks - Karlsruhe
Karlsruhe, , Germany
Institut für Diabetesforschung GmbH Münster
Münster, , Germany
RED-Institut GmbH
Oldenburg, , Germany
Kirigaokatsuda Hospital
Kitakyushu, , Japan
Osaka Kaisei Hospital
Osaka, , Japan
Sakai City Medical Center
Sakai, , Japan
Nakamura Clinic
Urasoe, , Japan
RESM Respiratory and Sleep Medical Care Clinic
Yokohama, , Japan
Enclifar Ensayos Clínicos Farmacológicos Sc
Chihuahua City, , Mexico
Diseno y Planeacion en Investigacion Medica
Guadalajara, , Mexico
Private Practice - Dr. Arechavaleta Granell Maria del Rosario
Guadalajara, , Mexico
Centro de Investigacion en Artritis y Osteoporosis SC
Mexicali, , Mexico
RM Pharma Specialists - Unidad Especializada en Datos
Mexico City, , Mexico
Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares
Mexico City, , Mexico
CEINV Salud
Monterrey, , Mexico
Chiayi Christian Hospital
Chiayi City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District, , Taiwan
Countries
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Other Identifiers
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J5P-MC-GZRA
Identifier Type: OTHER
Identifier Source: secondary_id
J5P-MC-GZ01
Identifier Type: OTHER
Identifier Source: secondary_id
J5P-MC-GZ02
Identifier Type: OTHER
Identifier Source: secondary_id
27226
Identifier Type: -
Identifier Source: org_study_id
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