Daiichi Sankyo has reported findings from the Phase III clinical trial of bempedoic acid / ezetimibe fixed-dose combination (FDC) tablet in hypercholesterolemia patients.

The FDC tablet is an oral ATP citrate lyase (ACL) inhibitor intended to minimise cholesterol synthesis in the liver. It is currently being reviewed by regulatory authorities in the US and EU.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

Study 053 investigated the safety, efficacy, and tolerability of the therapeutic over 12 weeks in 382 patients who had a history of atherosclerotic cardiovascular disease or are at high-risk for the disease.

The trial enrolled subjects who were on maximally tolerated statin therapy. Participants received the FDC tablet, comprising 180mg bempedoic acid and 10mg ezetimibe, or placebo.

Study 053 has met its primary endpoint and key secondary endpoints, demonstrating a significant decrease of 38% in LDL-cholesterol and 35% in high-sensitivity C-reactive protein (hsCRP) compared to placebo.

The tablet was well-tolerated and showed a favourable safety profile when given with maximally tolerated statin therapy.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

During the trial, the number of adverse events, serious adverse events, and discontinuations due to an event were observed to be similar to those in other active treatment arms.

Daiichi Sankyo Europe Antithrombotic and Cardiovascular Medical Affairs department head Wolfgang Zierhut said: “We are pleased to report the superior LDL-C and hsCRP lowering benefits versus placebo that the FDC of bempedoic acid with ezetimibe brings to patients at high risk of CVD who do not reach their target for LDL-C despite being on maximally tolerated statin therapy.

“These results add to the growing body of evidence supporting bempedoic acid and the bempedoic acid / ezetimibe FDC tablet.”

The results have been published in the European Journal of Preventative Cardiology.