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Eli Lilly and Company’s Mounjaro Displayed Cardiovascular Protection in New Head-to-Head Trial

Key Takeaways

  • Mounjaro demonstrated non-inferiority to Trulicity in reducing major adverse cardiovascular events in type 2 diabetes patients with cardiovascular disease.
  • Mounjaro showed additional benefits, including improved A1C, weight, renal function, and reduced all-cause mortality compared to Trulicity.
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Eli Lilly's Mounjaro shows significant cardiovascular benefits in a major trial enhancing treatment options for type 2 diabetes patients.

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In a head-to-head trial Lilly’s GLP-1 dual agonist demonstrated the ability to protect against cardiovascular events.

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Eli Lilly and Company announced the results from SURPASS-CVOT, a head-to-head Phase III cardiovascular outcomes trial comparing two incretin therapies in adults with type 2 diabetes as well as established atherosclerotic cardiovascular disease. SURPASS-CVOT enrolled upwards of 13,000 participants across 30 countries, with trials spanning over four and a half years.

Key Takeaways

  • Mounjaro achieved its primary objective in testing reaching non-inferiority.
  • The SURPASS-CVOT trial was the first-of-its-kind allowing for future head-to-head trials.
  • Testing results reinforce Mounjaro’s established safety and treatment properties.

Lilly’s Mounjaro (tirzepatide), a GIP/GLP-1 dual receptor agonist, was tested alongside Trulicity (dulaglutide), a GLP-1 receptor agonist showing definitive cardiovascular benefits in its REWIND study. During SURPASS-CVOT, Mounjaro reached its primary objective of demonstrating a non-inferior rate of major adverse cardiovascular events (MACE-3), including cardiovascular death, heart attack, and stroke while directly competing against Trulicity. Under a non-controlled environment for multiplicity-adjusted type-1 errors, Mounjaro portrayed improvements on critical measures of A1C weight, renal function, and all-cause mortality.

Kenneth Custer, Ph.D., executive vice president and president of Lilly cardiometabolic health mentioned the results of SURPASS-CVOT, saying, "Cardiovascular disease remains the leading cause of death among people living with type 2 diabetes, the SURPASS-CVOT results show that Mounjaro preserved the cardioprotective benefit of Trulicity, a GLP-1 receptor agonist while providing additional benefits, including greater kidney protection and a reduced overall risk of death. These findings strengthen the case for Mounjaro as a potential front-line treatment for people with type 2 diabetes and cardiovascular disease."1

Trial results

Mounjaro’s performance in the SURPASS-CVOT trials demonstrated the treatment’s capabilities, specifically providing patients an 8% reduction for risks of cardiovascular death, heart attack, and stroke when compared to Trulicity. These results provided Mounjaro the criteria of non-inferiority, while also displaying consistent results for all three MACE-3 components.

An indirect comparison of the SURPASS-CVOT and REWIND studies allocated Mounjaro to exhibit the following results:

  • A 16% lower chance of all-cause mortality compared to Trulicity
  • Mounjaro reduces the risk of MACE-3 by 28%
  • An overall 39% reduced chance of all-cause mortality
  • Slowed eGFR decline by 3.54mL/min/1.73 m2 at 36 months
  • Greater improvements of A1C and weight & cardiovascular biomarkers

Mounjaro and Trulicity both tested consistently within their established profiles for safety and tolerability, with the most reported adverse events for both being gastrointestinal-related. The adverse effects were resolved following the completion of dose escalation but following testing, a reported 13.3% of participants ceased Mounjaro treatments compared to 10.2% of Trulicity users.

The trial results for Mounjaro reaffirmed its established background in benefits for patients suffering from heart disease and type 2 diabetes, while also providing critical new data to assist in advancing developments for the medicine.

The results of SURPASS-CVOT are expected to be presented at the European Association for the Study of Diabetes annual meeting taking place in September this year. Results will also be published in a peer-reviewed journal while Lilly will submit the data to global regulatory authorities by years end.

Sources

  1. Lilly's Mounjaro (tirzepatide), a GIP/GLP-1 dual agonist, demonstrated cardiovascular protection in landmark head-to-head trial, reinforcing its benefit in patients with type 2 diabetes and heart disease Eli Lilly and Company July 31, 2025 https://www.prnewswire.com/news-releases/lillys-mounjaro-tirzepatide-a-gipglp-1-dual-agonist-demonstrated-cardiovascular-protection-in-landmark-head-to-head-trial-reinforcing-its-benefit-in-patients-with-type-2-diabetes-and-heart-disease-302517872.html

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