Clinical trial

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

Active, not recruiting · Phase 3 · 6 countries · Registry ID NCT06649045

Active, not recruitingPhase 3Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionOSA, Overweight or Obesity

Full registry criteria

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.

Treatments and study arms

Orforglipron

Drug

Administered orally.

Placebo

Drug

Administered orally.

Primary outcomes

Change from Baseline in Apnea-Hypopnea Index (AHI)Baseline to Week 52

Study locations

66 locations were listed when this page was built. The first 40 are shown.

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada🇦🇷 Buenos Aires, Argentina
Centro Médico Viamonte🇦🇷 Buenos Aires, Argentina
Centro de Investigaciones Metabólicas (CINME)🇦🇷 Buenos Aires, Argentina
Consultorio de Investigación Clínica EMO SRL🇦🇷 Buenos Aires, Argentina
Centro Privado de Medicina Respiratoria🇦🇷 Paraná, Argentina
INECO Neurociencias Oroño🇦🇷 Rosario, Argentina
Instituto Médico Río Cuarto🇦🇷 Río Cuarto, Argentina
Centro de Salud e Investigaciones Médicas🇦🇷 Santa Rosa, Argentina
Núcleo de Pesquisa Clínica do Rio Grande do Sul🇧🇷 Porto Alegre, Brazil
BR Trials - Ensaios Clinicos e Consultoria🇧🇷 São Paulo, Brazil
CEPIC - Centro Paulista de Investigação Clínica🇧🇷 São Paulo, Brazil
CPQuali Pesquisa 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