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The LEADER Trial: Liraglutide's Cardiovascular Evidence

TRIAL-000005

Part of the DietApp.com GLP-1 Trial Database, a comprehensive, regularly reviewed resource.

What It Is

LEADER, Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results, is the clinical trial that established liraglutide's approval for reducing cardiovascular risk in adults with type 2 diabetes. It enrolled 9,340 participants (4,668 on liraglutide, 4,672 on placebo) with type 2 diabetes at high cardiovascular risk, with a median follow-up of 3.8 years, one of the longer-duration major GLP-1 trials.

Key Results

LEADER demonstrated a reduction in major adverse cardiovascular events with liraglutide compared to placebo, forming the evidence base for Victoza's cardiovascular risk reduction indication. Post-hoc analyses of LEADER data have also identified kidney-protective effects, including slower decline in kidney function among participants with reduced baseline kidney function.

Why This Trial Still Matters

LEADER is one of the foundational cardiovascular outcome trials in the GLP-1 class, predating and informing the design of later trials like SUSTAIN-6 and SELECT. Mediation analyses of LEADER data have helped researchers understand which factors, blood sugar control, blood pressure, and others, actually drive the cardiovascular benefit seen with liraglutide.

References

  • PMC: Effects of Liraglutide and Semaglutide on Cardiovascular and Renal Outcomes, LEADER and SUSTAIN 6
  • Circulation: Effect of Semaglutide and Liraglutide on Kidney Outcomes, Pooled Analysis of SUSTAIN 6 and LEADER

Related Resources

Related Articles

  • The SUSTAIN-6 Trial
  • The SELECT Trial

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About DietApp.com

DietApp.com combines evidence-based GLP-1 medication education with practical treatment tracking tools. The information on DietApp.com is intended for educational purposes only and should not replace professional medical advice, diagnosis, or treatment.

Last medically reviewed and updated: July 11, 2026.

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