Esperion reports first Phase III hypercholesterolemia data

Esperion Therapeutics Inc. (NASDAQ:ESPR) said once-daily oral bempedoic acid (ETC-1002) met the primary endpoint in the Phase III CLEAR Tranquility (1002-048) trial to treat hypercholesterolemia in patients with atherosclerotic cardiovascular disease (ASCVD). The company also reported that two patients in the bempedoic acid arm had liver enzyme elevations that were more than three times the upper limit of normal.

On the 269-patient trial's primary endpoint, once-daily 180 mg oral bempedoic acid as an add-on therapy led to a significant placebo-adjusted reduction in LDL-C from baseline to week 12 of 28% (reduction of 23% vs. an increase of 5%, p<0.001). Bempedoic acid also met the secondary endpoint of reducing high-sensitivity C-reactive protein (hsCRP) levels from baseline to week 12 vs. placebo (reduction of 33% vs. an increase of 2%, p<0.001). The trial enrolled patients with ASCVD, or who were at high risk for ASCVD, with hypercholesterolemia inadequately controlled with ezetimibe and up to the lowest daily starting dose of a statin...