Clinical Trials

Date: 2015-10-12

Type of information: Halting of the trial

phase: 3

Announcement: halting of the trial

Company: Eli Lilly (USA - IN)

Product: evacetrapib

Action mechanism:

• cholesterol ester transfer protein inhibitor (CETP inhibitor). Evacetrapib (LY2484595) is a 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.

Disease: patients with high-risk atherosclerotic cardiovascular disease

Therapeutic area: Cardiovascular diseases

Country: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Czech Republic, Denmar, Estonia, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Republic of Korea, Lithuania, Mexico, The Netherlands, New Zealand, Poland, Puerto Rico, Romania, Russian Federation, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, UK, USA

Trial details:

• 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. (NCT01687998)

Latest news:

• • On October 12, 2015, Eli Lilly and the ACCELERATE study's academic leadership have accepted the recommendation of the independent data monitoring committee to terminate the Phase 3 trial of evacetrapib, due to insufficient efficacy. Lilly will discontinue development of evacetrapib for the treatment of high-risk atherosclerotic cardiovascular disease and will now conclude other studies in the program. 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 decision to discontinue development of evacetrapib is expected to result in a fourth-quarter charge to research and development expense of up to $90 million (pre-tax), or approximately $0.05 per share (after-tax). The company will incorporate this estimated charge into its updated 2015 guidance that will be provided as part of its third quarter 2015 earnings press release on Thursday, Oct. 22, 2015.
• • On July 27, 2015, Eli Lilly has accepted the recommendation of the ACCELERATE study data monitoring committee to continue the Phase 3 trial of 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. Eli Lilly is looking forward to receiving the ACCELERATE results in 2016.
• • On February 19, 2015, Eli Lilly announced that it has accepted the recommendation of the ACCELERATE study academic executive committee, based on emerging science in the cardiovascular field, to extend the Phase 3 trial of evacetrapib by approximately six months. The decision is not based on any data from ACCELERATE, as both the academic committee and the company remain blinded to efficacy results. Last patient visit in ACCELERATE - which is evaluating evacetrapib in approximately 12,000 people with high-risk atherosclerotic cardiovascular disease (ASCVD) -- is now expected in July 2016. The academic executive committee based its recommendation on analysis of recent results from other drugs being studied to reduce major adverse cardiovascular events (MACE). Both the committee and Lilly believe longer treatment will allow appropriate testing of the ACCELERATE hypothesis: that evacetrapib added to statins can reduce MACE events compared to statins alone in patients with ASCVD. As part of the study extension, a futility analysis previously anticipated in Q1 2015 is now expected to occur in Q3 2015.

Is general: Yes