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

What Was Tested

This registered phase 3 trial tested Orforglipron (Foundayo, non-peptide) for atherosclerosis, cardiovascular disease & high blood pressure.

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.

It had two arms (groups): Orforglipron (experimental) and Placebo (placebo comparator).

Participants will receive orforglipron orally + standard of care.

Participants will receive placebo orally + standard of care.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 7140 planned participants were the target.

It was open to people of any sex aged from 50 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Have established ASCVD and/or CKD.

The full record lists 1 inclusion and 3 exclusion criteria; among the exclusions: 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.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Orforglipron (Foundayo, non-peptide) and who got the comparison, which limits bias.

The Orforglipron (Foundayo, non-peptide) group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the atherosclerosis, cardiovascular disease & high blood pressure participants and researchers unaware of who received Orforglipron (Foundayo, non-peptide).

Those kept unaware of assignments: participant and investigator.

It started in 2025-12-01 with completion listed for 2031-08.

It ran at 566 sites in Argentina (59), Mexico (35), Brazil (34), China (30), Netherlands (23) and India (20).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Time to First Occurrence of Composite Endpoint of Major Cardiovascular Events (time frame: Baseline up to end of study (about 5 years)).

It also tracked 3 secondary outcomes, for example Time to First Occurrence of Composite Endpoint of Major Cardiovascular and Kidney Events, Change from Baseline in Total eGFR Slope and Time to Onset of Type 2 Diabetes.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Orforglipron (Foundayo, non-peptide) in 7140 people with atherosclerosis, cardiovascular disease & high blood pressure.

With 7140 participants it is a large trial for this field.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Orforglipron (Foundayo, non-peptide) compound page, Atherosclerosis, cardiovascular disease & high blood pressure research.