← Trials/Trial dossier/NCT07241390

RecruitingPhase 3

A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/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

Asset

Orforglipron

Oral · GLP-1 agonist

Listed sites

568

Recruiting sites

308

Enrollment

7,140

estimated

Study population

Cardiovascular disease, Chronic kidney disease

Key I/E criterion

Established ASCVD/CKD

Primary endpoint

5-point MACE (Non-fatal MI, Non-fatal stroke, Heart-failure hospitalization, Coronary revascularization)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07241390
Org study ID27771
Secondary ID2025-523123-22-00
Secondary IDJ2A-MC-GZPWEli Lilly and Company

Timeline

Milestones

Study first posted2025-11-21actual
Study start2025-12-01actual
Last update posted2026-05-22actual
Primary completion2031-08estimated (month precision)
Study completion2031-08estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Cardiovascular diseaseChronic kidney disease

Eligibility

Who can enroll

Minimum age50 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiovascular outcomes
2
Glycemic / diabetes
1
Renal / kidney
1

Cardiovascular outcomes

2 endpoints
Primary/protocol endpoint

Time to First Occurrence of Composite Endpoint of Major Cardiovascular Events

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

5-point MACE

time to event, event

componentsNon-fatal MI, Non-fatal stroke, Heart-failure hospitalization, Coronary revascularization, All-cause death

Secondary/protocol endpoint

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

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

Expanded / custom MACE composite

time to event, event

componentsNon-fatal MI, Non-fatal stroke, Heart-failure hospitalization, Coronary revascularization, eGFR, change, End-stage renal disease, All-cause death

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Time to Onset of Type 2 Diabetes

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

Time to T2DM onset

time to event, event

Renal / kidney

1 endpoint
Secondary/protocol endpoint

Change from Baseline in Total eGFR Slope

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

eGFR slope (total)

change from baseline, improvement

LOINC 98979-8

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.