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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
Lead sponsor
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
Exclusion criteria
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 endpointsTime 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
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 endpointTime 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 endpointChange 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 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.