Lilly Provides Update on Evacetrapib Phase 3 Trial
INDIANAPOLIS, Eli Lilly and Company 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."
About
evacetrapib
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.
About
ACCELERATE
The ACCELERATE study is evaluating the
efficacy and safety of evacetrapib in participants with high-risk
atherosclerotic cardiovascular disease (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
revascularization, or hospitalization for unstable angina.
Source: Eli Lilly and Company
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