A Master Protocol to Investigate the Efficacy and Safety of Orforglipron Once Daily in Participants With Hypertension and Obesity or Overweight: Randomized, Double-Blind, Placebo-Controlled Trials (ATTAIN-HYPERTENSION)

ReclutandoFase 3ClinicalTrials.gov

ID: NCT06948422Tipo: INTERVENTIONALInicio: 30 de abr de 2025Fin estimado: 1 de sept de 2027

Traducción no disponible, mostrando original

Resumen

The GZPL master protocol will support 2 independent studies, J2A-MC-GZL1 (GZL1) and J2A-MC-GZL2 (GZL2). The purpose of this study is to create a framework to evaluate the safety and efficacy of orforglipron for the treatment of hypertension in participants with obesity or overweight.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Has systolic blood pressure (SBP) ≥ 140 mmHg and/or diastolic blood pressure (DBP) ≥ 90 mmHg (if DBP criteria alone is met, SBP must be ≥130 mmHg) at screening (Visit 1).
Has SBP ≥ 140 mmHg and/or DBP ≥ 90 mmHg (if DBP criteria alone is met, SBP must be ≥130 mmHg) at week 0 (Visit 3).
Untreated for hypertension, or on stable antihypertensive medications ≥ 30 days prior to Visit 1.
Have a body mass index (BMI) ≥ 25 kg/m².

Criterios de exclusión

Has SBP ≥170 mmHg and/or DBP ≥110 mmHg at Visit 1 or at Visit 3.
Has known secondary causes of hypertension
Have heart failure with reduced ejection fraction (HFrEF) diagnosis
Have had any of the following conditions within 90 days prior to screening.
hospitalization for hypertension or for congestive heart failure
acute coronary syndrome or acute myocardial infarction, or
cerebrovascular accident (stroke).
Have type 1 diabetes (T1D)
Have acute or chronic hepatitis, including a history of autoimmune hepatitis

Intervenciones

drug

Orforglipron

Administered orally.

drug

Placebo

Administered orally.

Ubicaciones

Instituto Médico Especializado (IME)

Buenos Aires, Argentina

ACTIVE_NOT_RECRUITING

CIPREC

Buenos Aires, Argentina

ACTIVE_NOT_RECRUITING

CIPREC

Buenos Aires, Argentina

ACTIVE_NOT_RECRUITING

CEMEDIC

Buenos Aires, Argentina

ACTIVE_NOT_RECRUITING

Instituto de Investigaciones Clínicas Córdoba

Córdoba, Argentina

ACTIVE_NOT_RECRUITING

Centro de Investigaciones Clínicas Baigorria

Granadero Baigorria, Argentina

ACTIVE_NOT_RECRUITING

INECO Neurociencias Oroño

Rosario, Argentina

ACTIVE_NOT_RECRUITING

Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica

Rosario, Argentina

ACTIVE_NOT_RECRUITING

Santa Maria de la Salud Centro Medico

San Isidro, Argentina

ACTIVE_NOT_RECRUITING

Patrocinadores

PrincipalEli Lilly and Company

Contactos

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

LillyTrials@Lilly.com 1-317-615-4559

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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