Study S001819

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

ClinicalTrials.gov record

Registration

Registration: NCT07241390
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: RECRUITING
Enrollment: 7140
Start: 2025-12-01
Primary completion: 2031-08
Lead sponsor: Eli Lilly and Company
Conditions: Atherosclerosis Cardiovascular Disease; Chronic Kidney Disease
Interventions: DRUG:Orforglipron; DRUG:Placebo
Results posted: FALSE
Individual participant data sharing: YES
Secondary identifiers: OTHER:J2A-MC-GZPW; CTIS:2025-523123-22-00; NIH:2025

Registered primary outcomes

Time to First Occurrence of Composite Endpoint of Major Cardiovascular Events [Baseline up to end of study (about 5 years)]

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