Eli Lilly's Mounjaro shows significant cardiovascular benefits in a major trial enhancing treatment options for type 2 diabetes patients.
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.
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
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:
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.
