Brief Summary

The purpose of this study is to measure cardiovascular outcomes with orforglipron compared with placebo in participants with atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). Participation in the study will last about 5 years.

Conditions

• Atherosclerosis Cardiovascular Disease
• Chronic Kidney Disease

Intervention / Treatment

• Drug: Orforglipron
• Drug: Placebo

Primary Outcome Measures

• Time to First Occurrence of Composite Endpoint of Major Cardiovascular Events (Baseline up to end of study (about 5 years))
  Composite endpoint includes nonfatal myocardial infarction, nonfatal stroke, hospitalization or urgent visit due to heart failure, coronary revascularization, or all-cause death

Countries

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Czechia, Estonia, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Poland, Romania, Serbia, Slovakia, South Africa, South Korea, Spain, Taiwan, Thailand, Tunisia, Turkey (Türkiye), Ukraine, United Kingdom

Locations and Investigators

• Instituto de Investigaciones Clínicas Bahia Blanca, Bahía Blanca, Argentina (Recruiting)
  • Daniel Vogel (Principal Investigator)
• CONEXA Investigacion Clinica S.A., Buenos Aires, Argentina (Recruiting)
  • María Scioscia (Principal Investigator)
• Buenos Aires Macula S.A, Buenos Aires, Argentina (Recruiting)
  • Augusto Lavalle Cobo (Principal Investigator)
• CIPREC, Buenos Aires, Argentina (Recruiting)
  • Fernando Guerlloy (Principal Investigator)
• Instituto Médico Especializado (IME), Buenos Aires, Argentina (Recruiting)
  • Patricia Castaño (Principal Investigator)
• Cicemo Srl, Buenos Aires, Argentina (Recruiting)
  • Alejandro de Dios (Principal Investigator)
• Cardiología Palermo, Buenos Aires, Argentina (Recruiting)
  • Paula Perez Terns (Principal Investigator)
• Consultorio Medico Investigador Principal Dr Besada, Buenos Aires, Argentina (Recruiting)
  • Diego Besada (Principal Investigator)
• Glenny Corp. S.A., Buenos Aires, Argentina (Recruiting)
  • Martin Koretzky (Principal Investigator)
• Organizacion Medica de Investigacion, Buenos Aires, Argentina (Recruiting)
  • Diego Alberto Carrozza (Principal Investigator)
• Stat Research S.A., Buenos Aires, Argentina (Recruiting)
  • Lucas Gutnisky (Principal Investigator)
• Investigaciones Medicas Imoba Srl, Buenos Aires, Argentina (Recruiting)
  • Silvia Orio (Principal Investigator)
• Centro de Investigaciones Metabólicas (CINME), Buenos Aires, Argentina (Recruiting)
  • Federico Perez Manghi (Principal Investigator)
• CIPREC, Buenos Aires, Argentina (Recruiting)
  • Angela Romero Zarante (Principal Investigator)
• Centro Médico Viamonte, Buenos Aires, Argentina (Recruiting)
  • Diego Aizenberg (Principal Investigator)
• Mautalen Salud e Investigación, Buenos Aires, Argentina (Recruiting)
  • Daniel Chirino Navarta (Principal Investigator)
• CEMEDIC, Buenos Aires, Argentina (Recruiting)
  • Claudio Majul (Principal Investigator)
• Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada, Buenos Aires, Argentina (Recruiting)
  • Emilio Alaguibe (Principal Investigator)
• Fundación Respirar, Buenos Aires, Argentina (Recruiting)
  • Marina Uhrig (Principal Investigator)
• CEMEDIAB, C.a.b.a., Argentina (Recruiting)
  • Alejandro Chertkoff (Principal Investigator)
• CEDIC, CABA, Argentina (Recruiting)
  • Elizabeth Gelersztein (Principal Investigator)
• Instituto de Cardiología "Juana F. Cabral", Corrientes, Argentina (Recruiting)
  • Julio Vallejos (Principal Investigator)
• Centro Diabetológico Dr. Waitman, Córdoba, Argentina (Recruiting)
  • Silvana Ernestina Solis (Principal Investigator)
• Instituto de Investigaciones Clínicas Córdoba, Córdoba, Argentina (Recruiting)
  • Ines Bartolacci (Principal Investigator)
• Centro Medico Privado San Vicente Diabetes, Córdoba, Argentina (Recruiting)
  • MARIA STEINACHER (Principal Investigator)
• Instituto Médico DAMIC, Córdoba, Argentina (Recruiting)
  • Adriana Villarino (Principal Investigator)
• Hospital Italiano de Córdoba, Córdoba, Argentina (Recruiting)
  • daniela Garcia Brasca (Principal Investigator)
• Sanatorio Esperanza, Esperanza, Argentina (Recruiting)
  • Guillermo Cursack (Principal Investigator)
• CIPADI - Centro Integral de Prevencion y Atencion en Diabetes, Godoy Cruz, Argentina (Recruiting)
  • Pedro Rosario Fabian Calella (Principal Investigator)
• Centro de Investigaciones Clínicas Baigorria, Granadero Baigorria, Argentina (Recruiting)
  • Maximiliano Sicer (Principal Investigator)
• Centro de Salud Renal Junín, Junín, Argentina (Recruiting)
  • AUGUSTO VALLEJOS (Principal Investigator)
• CIMeL, Lanus, Argentina (Recruiting)
  • Mariano Chahin (Principal Investigator)
• Centro de Investigaciones Médicas Mar del Plata, Mar del Plata, Argentina (Recruiting)
  • Adrian Hernandez Gauna (Principal Investigator)
• Instituto de Investigaciones Clínicas Mar del Plata, Mar del Plata, Argentina (Recruiting)
  • Sergio Nemi (Principal Investigator)
• Instituto de Cardiología Wolff, Mendoza, Argentina (Recruiting)
  • SEBASTIAN WOLFF (Principal Investigator)
• CER medical Institute, Quilmes, Argentina (Recruiting)
  • Santiago Torroba (Principal Investigator)
• DIM Clínica Privada, Ramos Mejía, Argentina (Recruiting)
  • Oscar Montaña (Principal Investigator)
• Instituto Médico Río Cuarto, Río Cuarto, Argentina (Recruiting)
  • Rodrigo Carnero (Principal Investigator)
• Fundacion Estudios Clinicos, Rosario, Argentina (Recruiting)
  • María Schiavoni (Principal Investigator)
• Fundación Innovaciencia, Rosario, Argentina (Recruiting)
  • Diego mendo (Principal Investigator)
• INECO Neurociencias Oroño, Rosario, Argentina (Recruiting)
  • María Cappiello (Principal Investigator)
• Instituto Especialidades de la Salud Rosario, Rosario, Argentina (Recruiting)
  • Ana Chiesa (Principal Investigator)
• Instituto Médico Catamarca IMEC, Rosario, Argentina (Recruiting)
  • Natacha Maldonado (Principal Investigator)
• Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica, Rosario, Argentina (Recruiting)
  • Horacio Sessa (Principal Investigator)
• Instituto de Investigaciones Clinicas Rosario, Rosario, Argentina (Recruiting)
  • Carolina Chacón (Principal Investigator)
• Laboratorio de Hemostasia y Trombosis, Rosario, Argentina (Recruiting)
  • Vanina Gorosito (Principal Investigator)
• Hospital Provincial del Centenario, Rosario, Argentina (Recruiting)
  • Martin Najenson (Principal Investigator)
• Clínica de Nefrología, Urología y Enfermedades Cardiovasculares, S3000epv, Argentina (Recruiting)
  • Judith Gaite (Principal Investigator)
• Santa Maria de la Salud Centro Medico, San Isidro, Argentina (Recruiting)
  • Virginia Kotliar Lublin (Principal Investigator)
• Centro de Investigaciones Médicas Tucuman, SAN M. de Tucuman, Argentina (Recruiting)
  • Leonardo Serra (Principal Investigator)

And 516 other sites.

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) (Study Director) — Eli Lilly and Company