Start of global phase 3 long-term safety/tolerability study in hyperlipidemia
The launch of the CLEAR phase 3 clinical program (Cholesterol Lowering via ETC-1002, an ACL-inhibiting Regimen) was announced, with the initiation of a long-term safety study.
This phase 3 randomized, multicenter, double-blind, placebo-controlled study will evaluate 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.
Bempedoic acid s an inhibitor of ATP Citrate Lyase, a well-characterized enzyme on the cholesterol biosynthesis pathway. Bempedoic acid inhibits cholesterol synthesis, decreases intracellular cholesterol, up-regulates LDL-receptors, and causes increased LDL-C clearance and reduced plasma levels of LDL-C.
The phase 3 program will focus on the development of bempedoic acid for statin intolerant patients with uncontrolled LDL-c levels. Further details on the phase 3 development strategy and the design of the planned cardiovascular outcomes trial are expected in Q2 2016.
Source: Press release Esperion Therapeutics, Januari 13, 2016