Clinical trial Recruiting at 512 sites Phase 3 Interventional Ages 50 and up

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.

More Chronic Kidney Disease trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages50 Years and up
SexAll
Enrollment7140 (estimated)
SponsorEli Lilly and Company
Industry-sponsored
Locations566 sites (Bahía Blanca and 565 other locations)
StatusRecruiting
StartedDecember 1, 2025
Main results expectedAugust 2031
Study endsAugust 2031
Registry record updatedNovember 4, 2026
Trial IDNCT07241390 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

  • 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
  • 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

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.