Physicians' Academy for Cardiovascular Education

Development CETP-inhibitor for high-risk atherosclerotic cardiovascular disease discontinued

Oct. 13, 2015 - news

An independent data monitoring committee has advised to terminate the phase 3 trial of the investigational medicine evacetrapib, due to insufficient efficacy. Eli Lilly and Company and the ACCELERATE study's academic leadership have accepted this recommendation. The development of evacetrapib for the treatment of high-risk atherosclerotic cardiovascular disease will be discontinued and other studies in the programme will be concluded.

The independent data monitoring committee based its recommendation on data from periodic data reviews, which suggested there was a low probability the study would achieve its primary endpoint based on results to date. The study is not being stopped for safety findings. After further analysis, results of the study will be presented in scientific forums in the future.

The ACCELERATE study was designed to evaluate the efficacy and safety of evacetrapib in participants with high-risk atherosclerotic cardiovascular disease. 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 - was designed as 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 was designed to be 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. 

"We're obviously disappointed in this outcome, as we hoped that evacetrapib would offer an advance in treatment for people with high-risk cardiovascular disease. We'll be working with investigators to appropriately conclude these trials," said David Ricks, Lilly senior vice president and president of Lilly Bio-Medicines.

Study author Steven Nissen remarked to FirstWord "I don't think that the strategy of CETP inhibition is going to work," adding that "evacetrapib was as good a drug in terms of its biological effects as anything we've seen [and] if it didn’t work, it is very unlikely that any other drugs in the class will work." S&P Capital IQ analyst Jeffrey Loo suggested to FirstWord that while the evacetrapib data "raises more uncertainty" about anacetrapib, it "doesn't necessarily mean [it] won't be efficacious." Merck is currently conducting a Phase III study of anacetrapib in about 30 000 patients.


Press release Eli Lilly and Company October 12, 2015 and news item on FirstWord