Esperion Therapeutics, Inc. announced initiation of its Phase 2 pharmacokinetics/pharmacodynamics (PK/PD) study (ETC-1002-035) of bempedoic acid in patients treated with atorvastatin 80 mg, the most commonly prescribed high-dose statin. The Company expects to announce top-line results from the study by mid-year. ETC-1002-035 is a Phase 2 randomized, double-blind, parallel group study evaluating 60 patients on stable atorvastatin 80 mg per day.

All patients in the study will receive 80 mg of atorvastatin for four weeks. Patients will then be randomized to receive either 180 mg of bempedoic acid, or placebo, for four weeks. The study will enroll patients at approximately 20 centers across the U.S. The primary objectives of the study are to assess the LDL-C lowering efficacy of bempedoic acid versus placebo on a background of atorvastatin 80 mg, as well as multiple-dose plasma PK of atorvastatin 80 mg alone and in combination with bempedoic acid.

Secondary objectives include assessing the effect of bempedoic acid on lipid and cardiometabolic biomarkers, including high-sensitivity C-reactive protein; characterizing the tolerability and safety of bempedoic acid; and evaluating the steady-state plasma PK of bempedoic acid. In February, the company also intends to initiate a Phase 1 clinical pharmacology study of bempedoic acid (ETC-1002-037), which will be an open label, drug-drug interaction study to assess the safety and tolerability of bempedoic acid at steady-state, as well as the PK of single doses of the highest-doses of the most commonly prescribed statins: atorvastatin 80 mg, rosuvastatin 40 mg, simvastatin 40 mg, and pravastatin 80 mg. The company expects to announce top-line results from the study by mid-year.