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

NCTNCT07241390Other id27771Other idJ2A-MC-GZPWOther id2025-523123-22-00Other id2025

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Recruiting
Phase: Phase 3
Enrollment: 7,140 participants (estimated)
Sponsor: Eli Lilly and Company · Industry
Design: Randomized · Double masking
Countries: 30 countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Czechia, Estonia, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Poland, Romania, Serbia, Slovakia, South Africa
Start: 1 Dec 2025
Primary completion: Aug 2031 (estimated)
Completion: Aug 2031 (estimated)
First posted: 21 Nov 2025
Last update posted: 8 Oct 2026
Conditions: Atherosclerosis Cardiovascular Disease · Chronic Kidney Disease

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2026202820302032

Ph 3
A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)
NCT07241390
1 Dec 2025 to est. Aug 2031

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

OrforglipronDrug
PlaceboDrug

Arms2

Experimental
Orforglipron
Participants will receive orforglipron orally + standard of care
Placebo comparator
Placebo
Participants will receive placebo orally + standard of care

Primary outcomes1

Outcomes the sponsor listed as primary.

Time to First Occurrence of Composite Endpoint of Major Cardiovascular Events
Time frame · Baseline up to end of study (about 5 years)
Registry description
Composite endpoint includes nonfatal myocardial infarction, nonfatal stroke, hospitalization or urgent visit due to heart failure, coronary revascularization, or all-cause death

Secondary outcomes(3)

Time to First Occurrence of Composite Endpoint of Major Cardiovascular and Kidney Events
Time frame · Baseline up to end of study (about 5 years)
Registry description
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
Change from Baseline in Total eGFR Slope
Time frame · Baseline up to end of study (about 5 years)
Time to Onset of Type 2 Diabetes
Time frame · Baseline up to end of study (about 5 years)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 50 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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