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."
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 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.
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; [email protected]
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SOURCE Eli Lilly and Company