Esperion Therapeutics, Inc. announced the start of a global Phase 3 long-term safety and tolerability study (ETC-1002-040) of bempedoic acid in patients with hyperlipidemia whose LDL-C is not adequately controlled with low- and moderate-dose statins. This study will enable the Company to understand the 52 week safety profile of bempedoic acid, and top-line results are expected in the fourth quarter of 2017. ETC-1002-040 is a Phase 3 randomized, multicenter, double-blind, placebo-controlled study evaluating 180 mg of bempedoic acid versus placebo in 900 patients with hyperlipidemia at high cardiovascular disease risk and whose LDL-C is not adequately controlled with maximally tolerated lipid-modifying therapy.

The study will enroll patients at approximately 125 sites in the U.S., Canada and the European Union. The primary objective is to assess safety and tolerability of patients treated with bempedoic acid for 52 weeks. Secondary objectives include assessing the effects of bempedoic acid on other lipid and cardiometabolic risk markers, including LDL-C and high-sensitivity C-reactive protein.

This study marks the launch of the Phase 3 clinical program – known as Cholesterol Lowering via ETC-1002, an ACL-inhibiting Regimen (CLEAR) – which will be focused on the development of bempedoic acid for statin intolerant patients with uncontrolled LDL-C levels. The Company will provide details of the full Phase 3 global development strategy in the second quarter of 2016. Separately, the company anticipates formalizing and communicating the design of the planned cardiovascular outcomes trial in the second quarter of 2016.