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Orforglipron to lower cardiovascular events in adults with atherosclerotic cardiovascular disease or chronic kidney disease (ATTAIN-Outcomes)

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

Phase 3 Interventional Eli Lilly and Company · NCT07241390

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

PhasePhase 3
Study typeInterventional
Enrollment7140 (estimated)
Ages50 Years and up
SexAll
SponsorEli Lilly and Company Industry-sponsored
Locations568 sites (Bahía Blanca and 567 other locations)
Trial IDNCT07241390 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility criteria

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 this trial is running

Bahía Blanca and 567 other locations

+518 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Atherosclerosis Cardiovascular DiseaseChronic Kidney DiseaseHeart DiseaseKidney DiseaseOutcomesStroke
Last reviewed 2026-06-13 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.