A Study to Investigate the Efficacy and Safety of Orforglipron Once Daily in Participants With Peripheral Artery Disease: A Randomized, Double-Blind, Placebo Controlled Trial

ReclutandoFase 3ClinicalTrials.gov

ID: NCT07223593Tipo: INTERVENTIONALInicio: 31 de oct de 2025Fin estimado: 1 de jun de 2028

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to evaluate the effect and safety of orforglipron once daily in participants with Fontaine II peripheral arterial disease (PAD). Participation in the study will last about 58 weeks.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Have symptomatic PAD with intermittent claudication of Fontaine Stage II
Have an Ankle Brachial Index (ABI) of 0.9 or less

Criterios de exclusión

Have a body mass index (BMI) less than 23 kilogram per square meter (kg/m2)
Have Hemoglobin A1c (HbA1c) greater than 10%
Have walking ability limited by conditions other than PAD
Have a planned lower limb surgery or any other surgery affecting walking ability
Had peripheral revascularization procedure within 90 days prior to the day of screening or planning to undergo peripheral revascularization during the clinical trial
Had stroke, transient ischemic attack, myocardial infarction, coronary or carotid revascularization, or hospitalization for unstable angina pectoris within 60 days prior to screening
Have heart failure presently classified as being in New York Heart Association class III - IV

Intervenciones

drug

Orforglipron

Administered orally

drug

Placebo

Administered orally

Ubicaciones

CIPREC

Buenos Aires, Argentina

NOT_YET_RECRUITING

Sanatorio Finochietto

Buenos Aires, Argentina

NOT_YET_RECRUITING

CEMEDIC

Buenos Aires, Argentina

NOT_YET_RECRUITING

Instituto de Investigaciones Clínicas Córdoba

Córdoba, Argentina

NOT_YET_RECRUITING

DIM Clínica Privada

Ramos Mejía, Argentina

NOT_YET_RECRUITING

INECO Neurociencias Oroño

Rosario, Argentina

NOT_YET_RECRUITING

Instituto de Investigaciones Clinicas Rosario

Rosario, Argentina

NOT_YET_RECRUITING

Go Centro Medico San Nicolás

San Nicolás, Argentina

NOT_YET_RECRUITING

Centro de Salud e Investigaciones Médicas

Santa Rosa, Argentina

NOT_YET_RECRUITING

Patrocinadores

PrincipalEli Lilly and Company

Contactos

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

CONTACT

LillyTrials@Lilly.com 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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