CLEAR wisdom and why is this being presented at the March 18th Late breaking Clinical Trial session in New Orleans?

What is CLEAR Wisdom?

It sounds like something from your doctor of philosophy and your brain, but it’s really about a potentially valuable new treatment for your heart. If you visit ClinicalTrials.gov (the major site for any US study), you will see that the unique number for this study is NCT 02991118. This is a long-term study of a new drug called bempedoic acid (no brand name as yet since it is investigational), which also goes by ETC 1002.

This study has several things going for it:

  • The drug works in a new way to lower cholesterol and is actually also being studied in a different study combined with an older medicine to see if this gets even stronger results.
  • It is a long-term study, meaning that it will most likely have continued for enough time to show TRUE BENEFITS as well as uncovering possible risks.
  • This isn’t a study of healthy people with minimal chance of having problems. CLEAR Wisdom is looking at people with increased levels of abnormal lipids (hyperlipidemia) at HIGH RISK of heart and blood vessel (cardiovascular) problems.
  • The study has a reasonable patient (sample) size of roughly 700 people.
  • It is a trial of bempedoic acid added to adults with high cholesterol.
  • You only have to take this medicine once a day.
  • It’s being presented at a major heart meeting (The American College of Cardiology) with a balanced and objective discussion.

Why could this study be important?

Many many patients have problems tolerating (Statin intolerance) the widely used family medicines known as HMG-CoA Reductase inhibitors (AKA statins). The names are familiar because they all end in statin (rosuvastatin-Crestor, atorvastatin-Lipitor, etc.).

There is a clear unmet medical need for a new agent that avoids statin mechanisms of action—bempedoic acid works on liver specific ATP-citrate lyase (trust me, this is a different way of working versus statins.

As always, we have to wait for the ACC meeting and for the FDA to approve the medicine, but this phase 3 study (the last phase before FDA approval) holds great promise!

For additional information, look at the study itself on clinicaltrials.gov. We will be attending the ACC meeting in March and will post and blog more as the news becomes available!

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