Esperion says six-week Phase 2 study met primary endpoint of LDL-C lowering
Esperion Therapeutics announced top-line results from the Phase 2 clinical study, also known as the triplet oral therapy study, evaluating the LDL-C lowering efficacy and safety of the bempedoic acid / ezetimibe combination plus atorvastatin 20 mg, versus placebo, in patients with hypercholesterolemia. The six-week study met its primary endpoint of greater LDL-C lowering from baseline of 64 percent in the bempedoic acid / ezetimibe combination plus atorvastatin group, as compared to placebo. Ninety five percent of patients receiving treatment achieved greater than or equal to 50 percent LDL-C lowering reduction and 90 percent achieved LDL-C levels of less than 70 mg/dL. The bempedoic acid / ezetimibe combination plus atorvastatin also demonstrated a reduction of 48 percent in high-sensitivity C-reactive protein, an important marker of the underlying inflammation associated with cardiovascular disease. There were no reported serious adverse events, no difference in muscle-related adverse events, or discontinuations due to muscle-related AEs, in the treatment group, as compared to the placebo group. The bempedoic acid / ezetimibe combination plus atorvastatin produced no elevations in liver function tests or creatine kinase. The bempedoic acid / ezetimibe combination plus atorvastatin was observed to be safe and well-tolerated.