A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)

NCT07241390
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Recruiting
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Participants
7,140
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Lead sponsor
Eli Lilly and Company
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Start date
2025-12-01
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Number of sites
567
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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.
clinicaltrials.gov
Short title
A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)
clinicaltrials.gov
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
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2031-08-01
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First posted
2025-11-21
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Registry last updated
2026-08-24
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Primary completion date
2031-08-01
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Start date
2025-12-01
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Participants
7,140
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Participant count basis
Estimated
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Planned participants
7,140
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Protocol amendments
0
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Number of sites
567
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Eli Lilly and Company
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Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT07241390
clinicaltrials.gov
ClinicalTrials.gov ID
NCT07241390
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. Time to First Occurrence of Composite Endpoint of Major Cardiovascular Events

    Timeframe: 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

  1. Time to First Occurrence of Composite Endpoint of Major Cardiovascular and Kidney Events

    Timeframe: 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, ≥40% sustained decline in estimated glomerular filtration rate (eGFR), end-stage kidney disease, or all-cause death

  2. Change from Baseline in Total eGFR Slope

    Timeframe: Baseline up to end of study (about 5 years)

  3. Time to Onset of Type 2 Diabetes

    Timeframe: Baseline up to end of study (about 5 years)

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
50 Years
Healthy volunteers
No

  • Have established ASCVD and/or CKD

  • 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
Sources for eligibility
clinicaltrials.gov

  • Instituto de Investigaciones Clínicas Bahia BlancaBahía Blanca, ArgentinaRecruiting
  • CONEXA Investigacion Clinica S.A.Buenos Aires, ArgentinaRecruiting
  • Buenos Aires Macula S.ABuenos Aires, ArgentinaRecruiting
  • CIPRECBuenos Aires, ArgentinaRecruiting
  • Instituto Médico Especializado (IME)Buenos Aires, ArgentinaRecruiting
  • Cicemo SrlBuenos Aires, ArgentinaRecruiting
  • Cardiología PalermoBuenos Aires, ArgentinaRecruiting
  • Buenos Aires, ArgentinaRecruiting
  • Glenny Corp. S.A.Buenos Aires, ArgentinaRecruiting
  • Organizacion Medica de InvestigacionBuenos Aires, ArgentinaRecruiting
  • Stat Research S.A.Buenos Aires, ArgentinaRecruiting
  • Investigaciones Medicas Imoba SrlBuenos Aires, ArgentinaRecruiting
  • Centro de Investigaciones Metabólicas (CINME)Buenos Aires, ArgentinaRecruiting
  • CIPRECBuenos Aires, ArgentinaRecruiting
  • Centro Médico ViamonteBuenos Aires, ArgentinaRecruiting
  • Mautalen Salud e InvestigaciónBuenos Aires, ArgentinaRecruiting
  • CEMEDICBuenos Aires, ArgentinaRecruiting
  • Centro Medico Dra. Laura Maffei- Investigacion Clinica AplicadaBuenos Aires, ArgentinaRecruiting
  • Fundación RespirarBuenos Aires, ArgentinaRecruiting
  • CEMEDIABC.a.b.a., ArgentinaRecruiting
  • CEDICCABA, ArgentinaRecruiting
  • Instituto de Cardiología "Juana F. Cabral"Corrientes, ArgentinaRecruiting
  • Córdoba, ArgentinaRecruiting
  • Instituto de Investigaciones Clínicas CórdobaCórdoba, ArgentinaRecruiting
  • Centro Medico Privado San Vicente DiabetesCórdoba, ArgentinaRecruiting

And 542 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2025
  • 2025-523123-22-00
  • J2A-MC-GZPW
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (4)