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Clinical Trial4 Jun 2026Phase 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 Company

Phase 3 cardiovascular outcomes trial testing orforglipron versus placebo in people with established atherosclerotic cardiovascular disease and/or chronic kidney disease. Event-driven study enrolling 7,140 participants with expected completion in August 2031, approximately 5 years duration. This positions Eli Lilly to compete directly with Novo Nordisk's cardiovascular claims for semaglutide by establishing orforglipron as the first small-molecule oral GLP-1 with proven cardiovascular benefits. The trial targets a high-risk population already established for GLP-1 cardiovascular benefit validation.

Strategic Signal

Eli Lilly is pursuing cardiovascular indication expansion for orforglipron to match Novo Nordisk's Wegovy cardiovascular claims approved in March 2024. The 5-year timeline means results will arrive well after oral semaglutide's obesity approval in January 2026, potentially limiting first-mover advantage despite orforglipron's dosing convenience. US CMS and EU HTA bodies will likely require head-to-head cardiovascular data versus established GLP-1s rather than placebo comparisons for premium reimbursement positioning.

GLP-1CardiovascularEli Lilly

Original Abstract

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. | Condition(s): Atherosclerosis Cardiovascular Disease; Chronic Kidney Disease | Primary endpoint(s): Time to First Occurrence of Composite Endpoint of Major Cardiovascular Events | Enrollment: 7,140 (estimated) | Phase: Phase 3 | Sponsor: Eli Lilly and Company | Expected completion: 2031-08 | Status: Recruiting | Last update: 2026-06-04

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