Protocolo maestro para investigar la eficacia y seguridad de orforglipron una vez al día en participantes con apnea obstructiva del sueño y obesidad o sobrepeso: ensayo aleatorizado, doble ciego y controlado con placebo

Activo, no reclutaFase 3ClinicalTrials.gov

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

Resumen

El estudio GZRA es un protocolo maestro que sustenta 2 estudios independientes, GZ01 y GZ02. Los participantes serán asignados al estudio correspondiente antes de la aleatorización. El objetivo de los estudios es evaluar la eficacia y seguridad de orforglipron en participantes con AOS moderada a grave y obesidad o sobrepeso. El estudio GZ01 incluirá participantes que no puedan o no deseen utilizar terapia PAP. El estudio GZ02 incluirá participantes que estén en terapia PAP durante al menos 3 meses al momento del tamizaje y planifiquen continuar con la terapia PAP durante el estudio.

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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