NCT07241390RecruitingPhase 3
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
Eli Lilly and Company562 sites in 6 countries7,140 target enrollmentStarted: December 1, 2025Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Eli Lilly and Company
- Enrollment
- 7,140
- Locations
- 562
- Primary Endpoint
- Time to First Occurrence of Composite Endpoint of Major Cardiovascular Events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Orforglipron
Experimental
Participants will receive orforglipron orally + standard of care
Intervention: Orforglipron (Drug)
Placebo
Placebo Comparator
Participants will receive placebo orally + standard of care
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Time to First Occurrence of Composite Endpoint of Major Cardiovascular Events
Time Frame: 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 Outcomes
- 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))
- Time to First Occurrence of Composite Endpoint of Major Cardiovascular and Kidney Events(Baseline up to end of study (about 5 years))
Investigators
Study Sites (562)
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