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NCT06649045

PHASE3

A Master Protocol for Orforglipron in Participants With Obstructive Sleep Apnea and Obesity or Overweight

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

600

Start Date

2024-10-22

Completion Date

2027-01

Last Updated

2025-09-29

Healthy Volunteers

Conditions

OSA Overweight or Obesity

Interventions

DRUG

Orforglipron

Administered orally.

DRUG

Placebo

Administered orally.

Inclusion Criteria: 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. Exclusion Criteria: 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.

Locations (66)

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, Taiwan

Chang Gung Medical Foundation-Linkou Branch

Taoyuan District, Taiwan

Clinical Research Directory

A Master Protocol for Orforglipron in Participants With Obstructive Sleep Apnea and Obesity or Overweight

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (66)