Recently Completed Studies of BEMPEDOIC ACID
Esperion announced on October 13, 2016 the bempedoic acid global pivotal Phase 3 CLEAR LDL-C lowering clinical development program will include patients with hypercholesterolemia on any statin at any dose based on positive top-line results from its Phase 2 pharmacokinetics and pharmacodynamics (PK/PD) study of bempedoic acid added to atorvastatin 80 mg (1002-035), and the previously completed Phase 1 and Phase 2 studies. Top-line results from 1002-035 demonstrated the eight-week study met its primary endpoint of greater LDL-C lowering from baseline of 22 percent (p=0.0028) with bempedoic acid 180 mg compared with placebo with all patients on a background of atorvastatin 80 mg. Bempedoic acid also demonstrated an incremental reduction of 35 percent (p=0.0020) in high-sensitivity C-reactive protein (hsCRP), an important marker of the underlying inflammation associated with cardiovascular disease. Bempedoic acid added to atorvastatin 80 mg produced no clinically relevant effects on atorvastatin PK, and appeared to be safe and well-tolerated, with no serious adverse events reported.
Esperion has studied bempedoic acid in 14 completed clinical studies, including three Clinical Pharmacology studies, three Phase 1 studies, and eight Phase 2 studies. Learn more.
Planned Studies of BEMPEDOIC ACID
Esperion plans to initiate before year-end three global pivotal Phase 3 Cholesterol Lowering via BEmpedoic Acid, an ACL-inhibiting Regimen (CLEAR) LDL-C lowering efficacy studies — 1002-046, 1002-047, and 1002-048 — in patients with hypercholesterolemia who are inadequately treated with current lipid-modifying therapies. Esperion is also expected to initiate before year-end the global cardiovascular outcomes trial (CVOT) — CLEAR Outcomes.
The proposed high-level global pivotal Phase 3 design details, as well as design details of the CLEAR Outcomes CVOT, are included below. Additional design details for 1002-046, 1002-047, and 1002-048 will be made available when the studies are expected to initiate before year-end.
- CLEAR Outcomes (1002-043): A randomized, double-blind, placebo-controlled study to assess the effects of bempedoic acid in “statin intolerant” patients who are at high risk of CV disease with hypercholesterolemia. The global study is expected to enroll about 12,600 patients at up to 1,000 sites in approximately 30 countries. Patients enrolled in the study will be required to have a history of, or be at high risk for, CV disease with LDL-C levels between 100 mg/dL and 190 mg/dL despite background lipid-lowering therapy. The trial will be an event-driven study with the primary efficacy endpoint of the effect of bempedoic acid versus placebo on the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, hospitalization for unstable angina, or coronary revascularization; also referred to as “five-component MACE”) and is expected to initiate before year-end.
- 1002-046: 24-week study to assess the 12-week LDL-C efficacy primary endpoint of bempedoic acid 180 mg versus placebo in patients with hypercholesterolemia (with or without ASCVD) not adequately treated with current lipid-modifying therapies. This study is designed to enroll 300 patients only able to tolerate less than the lowest approved daily starting dose of a statin and can be considered “statin intolerant.” This study is expected to initiate before year-end.
- 1002-047: 52-week study to assess the 12-week LDL-C efficacy primary endpoint of bempedoic acid 180 mg versus placebo in patients with hypercholesterolemia (with ASCVD and/or HeFH) not adequately treated with current lipid-modifying therapies. This study is designed to enroll approximately 750 patients and is expected to initiate before year-end.
- 1002-048: 12-week study to assess the LDL-C efficacy primary endpoint of bempedoic acid 180 mg versus placebo in patients with hypercholesterolemia (with or without ASCVD) when added to ezetimibe. This study is designed to enroll approximately 225 patients and is also expected to initiate before year-end.