Merck (MSD) and Pfizer have reported that the Phase III VERTIS cardiovascular (CV) outcomes clinical trial of Steglatro (ertugliflozin) met its primary endpoint in patients with type 2 diabetes and atherosclerotic CV disease.
Steglatro is indicated to improve glycemic control in adults with type 2 diabetes mellitus when given as an adjunct to diet and exercise.
The multi-centre, prospective, randomised, event-driven VERTIS CV trial compared the drug to placebo, added to background standard of care, in 8,246 patients with type 2 diabetes and atherosclerotic CV disease at 531 centres across 34 countries.
The primary endpoint of the trial was non-inferiority versus placebo on major adverse CV events (MACE), a composite of CV death, nonfatal myocardial infarction, or nonfatal stroke.
Key secondary endpoints included superiority on time to the composite of CV death or hospitalisation for heart failure (HHF), CV death alone and the composite of renal death, as well as dialysis/transplant or doubling of serum creatinine.
The primary endpoint was achieved, with the primary MACE outcome reporting in 11.9% of patients on Steglatro and 11.9% of those treated with placebo. However, ertugliflozin did not meet the key secondary endpoints of superiority versus placebo.
Meanwhile, the safety profile of the drug was consistent with that observed in prior studies.
Merck clinical research, diabetes and endocrinology associate vice-president Dr Sam Engel said: “The results of the VERTIS CV trial are a significant and important addition to the overall evidence for the cardiovascular safety profile of ertugliflozin.”
Earlier this month, Eli Lilly dosed the first participants in the Phase III SURPASS-CVOT cardiovascular outcomes trial of tirzepatide in patients with type 2 diabetes and atherosclerotic CV disease.
Tirzepatide is an investigational dual GIP and GLP-1 receptor agonist. The SURPASS-CVOT study’s primary endpoint measure is time to first occurrence of MACE-3, which is the composite endpoint of CV death, myocardial infarction or stroke.