ACCELERATE trial of evacetrapib extended by 6 months

The phase 3 ACCELERATE trial of the cholesterol ester transfer protein inhibitor evacetrapib will be extended by approximately 6 months, according to a press release issued by Eli Lilly and Company.

The decision to extend the trial was recommended by the ACCELERATE academic executive committee based on analysis of recent results from other drugs under investigation to reduce major adverse CV events. The extension will allow for longer treatment and thus more appropriate testing of the ACCELERATE hypothesis that evacetrapib plus statin therapy can reduce MACE vs. statin alone in patients with atherosclerotic CVD, according to the release.

The final patient visit for the trial is now projected for July 2016. A futility analysis that had been planned for the first quarter of 2015 will now occur in the third quarter of 2015, according to the release.

The phase, 3, double blind, placebo-controlled trial will include 12,095 patients with high-risk atherosclerotic CVD enrolled at 540 sites in 37 countries. The primary outcome is time to first incidence of CV events including MI, stroke, coronary revascularization, hospitalization due to unstable angina or CV-related death, according to study details on ClinicalTrials.gov.

Evacetrapib is not currently approved for an indication in the United States or internationally.