INDIANAPOLIS, July 27, 2015 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) 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. More information on
the ACCELERATE trial is available at http://clinicaltrials.gov/
About Eli Lilly and Company
Lilly is a global
healthcare leader that unites caring with discovery to make life
better for people around the world. We were founded more than a
century ago by a man committed to creating high-quality medicines
that meet real needs, and today we remain true to that mission in
all our work. Across the globe, Lilly employees work to discover
and bring life-changing medicines to those who need them, improve
the understanding and management of disease, and give back to
communities through philanthropy and volunteerism. To learn more
about Lilly, please visit us at www.lilly.com and
newsroom.lilly.com/social-channels.
P-LLY
This press release contains forward-looking statements (as that
term is defined in the Private Securities Litigation Reform Act of
1995) about evacetrapib as a potential treatment for patients with
ASCVD and reflects Lilly's current belief. However, as with
any pharmaceutical product, there are substantial risks and
uncertainties in the process of development and commercialization.
Among other things, there can be no guarantee that future study
results will be consistent with the results to date or that
evacetrapib will achieve its primary study endpoints or receive
regulatory approvals. For further discussion of these and
other risks and uncertainties, see Lilly's most recent Form 10-K
and Form 10-Q filings with the United States Securities and
Exchange Commission. Except as required by law, Lilly undertakes no
duty to update forward-looking statements to reflect events after
the date of this release.
Refer to: J. Scott
MacGregor, +1-317-440-4699; jsmacgregor@lilly.com
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SOURCE Eli Lilly and Company