A Phase 3 interventional study of Orforglipron and Placebo in Atherosclerosis Cardiovascular Disease and Chronic Kidney Disease, sponsored by Eli Lilly and Company. Recruiting at 568 sites in 38 countries. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
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.
Exclusion Criteria:
Participants will receive orforglipron orally + standard of care
Drug: Orforglipron
Participants will receive placebo orally + standard of care
Drug: Placebo
Administered orally
Also known as: LY3502970
Administered orally
Time to First Occurrence of Composite Endpoint of Major Cardiovascular Events
Composite endpoint includes nonfatal myocardial infarction, nonfatal stroke, hospitalization or urgent visit due to heart failure, coronary revascularization, or all-cause death
Time frame: Baseline up to end of study (about 5 years)
Time to First Occurrence of Composite Endpoint of Major Cardiovascular and Kidney Events
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
Time frame: Baseline up to end of study (about 5 years)
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)
Showing the first 100 of 568 sites across 38 countries.
Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting information: Study protocol, Sap, Csr
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Eli Lilly and Company