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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07241390

Enrollment

7140

Registered

2025-11-21

Start date

2025-12-01

Completion date

2031-08-01

Last updated

2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis Cardiovascular Disease, Chronic Kidney Disease

Keywords

Heart Disease, Kidney Disease, Outcomes, Stroke

Brief 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.

Interventions

DRUGOrforglipron

Administered orally

DRUGPlacebo

Administered orally

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Time to First Occurrence of Composite Endpoint of Major Cardiovascular and Kidney Events	Baseline up to end of study (about 5 years)	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	Baseline up to end of study (about 5 years)	—
Time to Onset of Type 2 Diabetes	Baseline up to end of study (about 5 years)	—

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

Contacts

CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

LillyTrials@Lilly.com317-615-4559

CONTACTPhysicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026