Primary endpoint met in the CLEAR Outcomes Trial of bempedoic acid▼ showing statistically significant relative risk reduction in major adverse CV events1,2

Primary endpoint met in the CLEAR Outcomes Trial of bempedoic acid▼ showing statistically significant relative risk reduction in major adverse CV events^1,2

• Topline results from the CLEAR Outcomes Trial demonstrate that bempedoic acid reduces the risk of serious cardiovascular (CV) events in patients with, or who are at, high risk for cardiovascular disease (CVD) with elevated low-density lipoprotein cholesterol (LDL-C) levels2,3
• The results position bempedoic acid as the first oral adenosine triphosphate-citrate lyase (ACL) inhibitor acting as a lipid-lowering therapy, known to reduce both LDL-C levels and risk of major adverse CV events2
• Comprehensive data will be presented at an international scientific congress in March 2023

 Uxbridge, United Kingdom (08 December, 2022) – Daiichi Sankyo UK, (hereafter, DSUK) announced today that the primary endpoint was met in the Phase 3 cardiovascular CLEAR (Cholesterol Lowering via Bempedoic acid, an ATP citrate lyase (ACL)-Inhibiting Regimen) Outcomes Trial, demonstrating statistically significant relative risk reduction in major adverse CV events (MACE-4) in patients treated with 180 mg/day bempedoic acid compared to placebo (with no or very low statin background).¹

Comprehensive data from the CLEAR Outcomes Trial, led by US-based company Esperion Therapeutics Inc., will be presented at an international scientific congress in March 2023. Data will then subsequently submitted to all applicable regulatory authorities. The initial findings from the data indicate that bempedoic acid can help to reduce both LDL-C levels and the risk of major adverse CV events.²

CLEAR Outcomes was a Phase 3, event-driven, randomised, multicentre, double-blind, placebo[1]controlled trial designed to evaluate whether treatment with bempedoic acid reduces the risk of CV events in patients with or who are at high risk for CVD with documented statin intolerance (an inability to tolerate two or more statins, one at a low dose) and elevated LDL-C levels (fasting blood LDL-C ≥ 100mg/dL (2.6 mmol/L)). ² The study, which was fully enrolled in August 2019,⁴ included 14,014 patients at over 1,200 sites in 32 countries.² Patients had at least 36 months of follow-up.⁴