Eli Lilly’s GIP/GLP-1 dual receptor agonist Mounjaro (tirzepatide) has demonstrated cardiovascular protection in a late-stage study of patients with type 2 diabetes (T2D) and established atherosclerotic cardiovascular disease.
The head-to-head SURPASS-CVOT trial has been comparing the drug against the company’s Trulicity (dulaglutide), a GLP-1 receptor agonist that has already shown a definitive cardiovascular benefit in a previous clinical study.
Mounjaro achieved the primary endpoint, demonstrating a non-inferior rate of major adverse cardiovascular events compared to Trulicity.
In the trial, which lasted more than four and a half years, the risk of cardiovascular death, heart attack or stroke was 8% lower for Mounjaro versus Trulicity. The rate of all-cause mortality was also 16% lower for Mounjaro compared to Trulicity, and Lilly’s drug led to greater improvements in A1C, weight and cardiovascular biomarkers, including lipids and systolic blood pressure.
Kenneth Custer, executive vice president and president, Lilly Cardiometabolic Health, said: “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 T2D and cardiovascular disease.”
Approximately 38.4 million people in the US are affected by diabetes, with T2D accounting for the majority of cases. Patients with diabetes, particularly T2D, are at an increased risk of cardiovascular disease (CVD), as well as other serious complications such as chronic kidney disease.
Lilly’s tirzepatide is already approved in the US to improve glycaemic control in adults with T2D under the brand name Mounjaro, and as Zepbound for weight management in certain obese or overweight adults and for severe obstructive sleep apnea in adults with obesity.
The drug is also approved as Mounjaro in some countries outside the US for adults with T2D, obesity or those who are overweight who also have a weight-related co-morbid condition.
Detailed results for SURPASS-CVOT will be presented at the European Association for the Study of Diabetes annual meeting in September, Lilly said, adding that it is planning to submit the data to global regulatory authorities by the end of the year.