NCT07241390

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 7,140 (estimated)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Atherosclerosis Cardiovascular Disease
• Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	Orforglipron	Administered orally
DRUG	Placebo	Administered orally

Timeline

• Start date: 2025-12-01
• Primary completion: 2031-08-01
• Completion: 2031-08-01
• First posted: 2025-11-21
• Last updated: 2026-04-17

Locations

568 sites across 38 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, South Korea, Spain, Taiwan, Thailand, Tunisia, Turkey (Türkiye), Ukraine, United Kingdom