Orforglipron to lower cardiovascular events in adults with atherosclerotic cardiovascular disease or chronic kidney disease (ATTAIN-Outcomes)
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Orforglipron on the Incidence of Major Adverse Cardiovascular Events in Participants With Established Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease
Run by Eli Lilly and Company · NCT07241390 · Data updated 2026-11-12
This trial tests whether orforglipron reduces heart-related events compared with placebo in adults with atherosclerotic cardiovascular disease and/or chronic kidney disease.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 50 Years and up |
| Sex | All |
| Enrollment | 7140 (estimated) |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Locations | 566 sites (Bahía Blanca and 565 other locations) |
| Status | Recruiting |
| Started | December 1, 2025 |
| Main results expected | August 2031 |
| Study ends | August 2031 |
| Registry record updated | November 4, 2026 |
| Trial ID | NCT07241390 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with established atherosclerotic cardiovascular disease and/or chronic kidney disease who do not have type 1 diabetes, have not had a major cardiac event within the prior 60 days, and do not have NYHA Class IV heart failure.
✕Probably not a fit
People with type 1 diabetes, a recent major heart condition (within 60 days), or severe (NYHA Class IV) heart failure are excluded and are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 3, randomized, placebo-controlled study compares orforglipron with placebo in adults who have established ASCVD and/or CKD. Participants will be assigned to receive orforglipron or matching placebo and followed for about five years to capture major cardiovascular outcomes such as myocardial infarction, stroke, and cardiovascular death. Key exclusion criteria include type 1 diabetes, a major cardiac event within 60 days before screening, and NYHA Class IV heart failure. The primary analysis will compare the incidence of predefined cardiovascular events between the treatment arms.
Why it matters
Potential benefit: If effective, orforglipron could lower the risk of heart attacks, strokes, and other major cardiovascular events in people with ASCVD and/or CKD.
How similar studies have gone: Other large trials of GLP-1 receptor agonists and related agents have shown reductions in major cardiovascular events in patients with type 2 diabetes and high cardiovascular risk, so the approach has precedent though orforglipron's specific outcomes are being tested here.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have established ASCVD and/or CKD Exclusion Criteria: * Have type 1 diabetes * Have had a major heart condition within 60 days prior to screening * Have New York Heart Association Functional Classification Class IV heart failure
Where it's running
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Instituto de Investigaciones Clínicas Bahia Blanca
Bahía Blanca, Argentina Recruiting -
CONEXA Investigacion Clinica S.A.
Buenos Aires, Argentina Recruiting -
Buenos Aires Macula S.A
Buenos Aires, Argentina Recruiting -
Ciprec
Buenos Aires, Argentina Recruiting -
Instituto Médico Especializado (IME)
Buenos Aires, Argentina Recruiting -
Cicemo Srl
Buenos Aires, Argentina Recruiting
Show 44 more locations
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Cardiología Palermo
Buenos Aires, Argentina Recruiting -
Consultorio Medico Investigador Principal Dr Besada
Buenos Aires, Argentina Recruiting -
Glenny Corp. S.A.
Buenos Aires, Argentina Recruiting -
Organizacion Medica de Investigacion
Buenos Aires, Argentina Recruiting -
Stat Research S.A.
Buenos Aires, Argentina Recruiting -
Investigaciones Medicas Imoba Srl
Buenos Aires, Argentina Recruiting -
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires, Argentina Recruiting -
Ciprec
Buenos Aires, Argentina Recruiting -
Centro Médico Viamonte
Buenos Aires, Argentina Recruiting -
Mautalen Salud e Investigación
Buenos Aires, Argentina Recruiting -
Cemedic
Buenos Aires, Argentina Recruiting -
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires, Argentina Recruiting -
Fundación Respirar
Buenos Aires, Argentina Recruiting -
Cemediab
C.a.b.a., Argentina Recruiting -
Cedic
Caba, Argentina Recruiting -
Instituto de Cardiología "Juana F. Cabral"
Corrientes, Argentina Recruiting -
Centro Diabetológico Dr. Waitman
Córdoba, Argentina Recruiting -
Instituto de Investigaciones Clínicas Córdoba
Córdoba, Argentina Recruiting -
Centro Medico Privado San Vicente Diabetes
Córdoba, Argentina Recruiting -
Instituto Médico DAMIC
Córdoba, Argentina Recruiting -
Hospital Italiano de Córdoba
Córdoba, Argentina Recruiting -
Sanatorio Esperanza
Esperanza, Argentina Recruiting -
CIPADI - Centro Integral de Prevencion y Atencion en Diabetes
Godoy Cruz, Argentina Recruiting -
Centro de Investigaciones Clínicas Baigorria
Granadero Baigorria, Argentina Recruiting -
Centro de Salud Renal Junín
Junín, Argentina Recruiting -
CIMeL
Lanus, Argentina Recruiting -
Centro de Investigaciones Médicas Mar del Plata
Mar del Plata, Argentina Recruiting -
Instituto de Investigaciones Clínicas Mar del Plata
Mar del Plata, Argentina Recruiting -
Instituto de Cardiología Wolff
Mendoza, Argentina Recruiting -
CER medical Institute
Quilmes, Argentina Recruiting -
DIM Clínica Privada
Ramos Mejía, Argentina Recruiting -
Instituto Médico Río Cuarto
Río Cuarto, Argentina Recruiting -
Fundacion Estudios Clinicos
Rosario, Argentina Recruiting -
Fundación Innovaciencia
Rosario, Argentina Recruiting -
INECO Neurociencias Oroño
Rosario, Argentina Recruiting -
Instituto Especialidades de la Salud Rosario
Rosario, Argentina Recruiting -
Instituto Médico Catamarca IMEC
Rosario, Argentina Recruiting -
Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica
Rosario, Argentina Recruiting -
Instituto de Investigaciones Clinicas Rosario
Rosario, Argentina Recruiting -
Laboratorio de Hemostasia y Trombosis
Rosario, Argentina Recruiting -
Hospital Provincial del Centenario
Rosario, Argentina Recruiting -
Clínica de Nefrología, Urología y Enfermedades Cardiovasculares
S3000epv, Argentina Recruiting -
Santa Maria de la Salud Centro Medico
San Isidro, Argentina Recruiting -
Centro de Investigaciones Médicas Tucuman
SAN M. de Tucuman, Argentina Recruiting
+516 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Email: LillyTrials@Lilly.com
- Phone: 317-615-4559
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.