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A Master Protocol for Orforglipron in Participants With Obstructive Sleep Apnea and Obesity or Overweight
600 patients around the world
Available in Brazil, Argentina, Mexico
Eli Lilly and Company
19Research sites
600Patients around the world
This study is for people with
Sleep disorders
Sleep apnea
Obesity
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Master GZRA inclusion criteriaHave AHI ≥15 on PSG as part of the trial at screening (V1).Have body mass index (BMI) ≥27 kg/m².Study 1 GZ01 inclusion criteriaParticipants 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 criteriaParticipants 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 criteriaHave 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 criteriaHave 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 temporarily discontinue PAP therapy for 7 days prior to PSG testing during the study.
Sites
Centro de Investigaciones Metabólicas (CINME) S.A. - CABA, Buenos Aires
Recruiting
Centro Médico Viamonte SRL - CABA, Buenos Aires
Recruiting
Centro Médico Maffei - CABA, Buenos Aires
Recruiting
Fundación Centro de Salud e Investigaciones Médicas (CESIM)
Recruiting
Centro Privado de Medicina Respiratoria - CPMR
Recruiting
INECO Neurociencias Oroño - Rosario
Recruiting
Investigación Clínica Aplicada S.R.L.
Recruiting
Consultorio de Investigación Clinica EMO SRL
Recruiting
Instituto Médico Río Cuarto
Recruiting
Centro Paulista de Investigação Clínica - CEPIC
Recruiting
StudyATTAIN-OSA
SponsorEli Lilly and Company
Study typeInterventional
Conditions
Sleep apneaObesity
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06649045
