Esperion (NASDAQ: ESPR) today announced positive top-line results from its global, pivotal Phase 3 clinical study (Study 2 or 1002-047). This trial was a 52-week, randomized, double-blind, placebo-controlled study to evaluate the LDL-C lowering efficacy and the safety and tolerability of bempedoic acid 180 mg compared to placebo in patients with atherosclerotic cardiovascular disease (ASCVD) and/or heterozygous familial hypercholesterolemia (HeFH). These results complete our global pivotal phase 3 LDL-C lowering development program of bempedoic acid.
The study included 779 high cardiovascular risk patients taking maximally tolerated statins who required additional LDL-C lowering. The study achieved its efficacy endpoints and other key measures at 12 weeks, including:
- On-treatment LDL-C lowering of an additional 18 percent (vs. placebo, p<0.001), and in the intent to treat analysis, LDL-C lowering of an additional 17 percent (p<0.001)
- Reduction of 19 percent in high-sensitivity C-reactive protein (hsCRP), an important marker of the underlying inflammation associated with cardiovascular disease
- Reduction in hemoglobin A1c (HbA1c) of 0.21% vs. placebo in patients with diabetes
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