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.
"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
"This unfortunate outcome for evacetrapib does not change our ability to generate long-term growth," said
The decision to discontinue development of evacetrapib is expected to result in a fourth-quarter charge to research and development expense of up to
The ACCELERATE study was designed to evaluate 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 - 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. More information on the ACCELERATE trial is available at https://clinicaltrials.gov.
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This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Lilly's product pipeline and about charges relating to the decision to discontinue development of evacetrapib and reflects Lilly's current beliefs. However, there are substantial risks and uncertainties in the process of pharmaceutical research, development, and commercialization. For further discussion of these and other risks and uncertainties, see Lilly's most recent 10-K and 10-Q filings with the