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New study will assess bempedoic acid in patients treated with high-dose statins
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Esperion Therapeutics, Inc. announced the initiation of a phase 2 study of bempedoic acid in patients treated with high-dose atorvastatin.
The randomized, double blind, parallel-group study will evaluate 60 patients on stable atorvastatin 80 mg per day. All participants will receive atorvastatin 80 mg for 4 weeks and then undergo random assigned to bempedoic acid 180 mg or placebo for another 4 weeks. The study will be conducted at approximately 20 U.S. centers, according to a press release.
The researchers’ primary objective is to study the LDL-lowering efficacy of bempedoic acid vs. placebo on a background of high-dose atorvastatin, as well as multiple-dose plasma pharmacokinetics of atorvastatin 80 mg alone and in combination with bempedoic acid. Researchers will also assess the effect of bempedoic acid on lipid and cardiometabolic parameters, tolerability and safety, and the steady-state plasma pharmacokinetics of combination therapy, according to the release.
Esperion expects to announce top-line results of this study by mid-2016, according to the release.