Eli Lilly and Company, a global healthcare leader, has accepted the recommendation of the ACCELERATE study data monitoring committee to continue the phase 3 trial of the investigational medicine evacetrapib, based on data from an interim futility analysis.
Last patient visit in ACCELERATE - which is evaluating evacetrapib in approximately 12,000 patients with high-risk atherosclerotic cardiovascular disease (ASCVD) - is expected in July 2016.
"We believe that evacetrapib, if approved, could offer a significant benefit in the treatment of high-risk cardiovascular disease," said David Ricks, Lilly senior vice president and president of Lilly Bio-Medicines.
"While pleased that the trial continues, we need to complete the ACCELERATE study to understand the potential for evacetrapib. The interim futility test was designed to assess whether the drug had any possibility of achieving its primary endpoints. We look forward to receiving the ACCELERATE results in 2016."
Evacetrapib (LY2484595) is a potent and selective inhibitor of cholesteryl ester transfer protein (CETP), and in clinical studies has demonstrated effects on high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, and cholesterol efflux. Evacetrapib is in phase 3 clinical studies and is not approved as a treatment for prevention or reduction of cardiovascular risk or any other indication anywhere in the world.
The ACCELERATE study is evaluating the efficacy and safety of evacetrapib in participants with ASCVD. The pivotal phase 3 trial -- Assessment of Clinical Effects of Cholesteryl Ester Transfer Protein Inhibition With Evacetrapib in Patients at a High Risk for Vascular Outcomes - is a multi-center, randomized, double-blind, placebo-controlled trial being conducted at 540 sites in 37 countries, with 12,095 patients enrolled. The primary outcome measure is time to first occurrence of any component of the composite cardiovascular events of cardiovascular death, myocardial infarction, stroke, coronary revascularisation, or hospitalisation for unstable angina.