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

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT06649045Tipo: INTERVENTIONALInicio: 22 de oct de 2024Fin estimado: 1 de ene de 2027

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

have AHI ≥15 on PSG as part of the trial at screening (V1).
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.

Criterios de exclusión

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.
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.

Intervenciones

drug

Orforglipron

Administered orally.

drug

Placebo

Administered orally.

Ubicaciones

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

Patrocinadores

PrincipalEli Lilly and Company

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