Esperion Therapeutics announced a global trial to assess the effects of bempedoic acid on the occurrence of major CV events is launching.
Researchers for the randomized, double blind, placebo-controlled CLEAR Outcomes study expect to enroll 12,600 patients with hypercholesterolemia and high CVD risk, according to a press release issued by the company.
The study will span across 600 sites in about 30 countries and is estimated to last approximately 4.75 years.
The trial will measure the effect of bempedoic acid vs. placebo on the risk for major adverse CV events in patients with a history of or high risk for CVD and LDL level 100 mg/dL to 190 mg/dL despite maximally tolerated statin or other lipid-lowering therapy, according to the release.
“The start of the CLEAR Outcomes [CV outcomes trial] is one of the last and most exciting steps in the development of bempedoic acid, and we are very pleased to have begun dosing patients,” Tim M. Mayleben, president and CEO of Esperion. “We believe bempedoic acid has the potential to provide a well-tolerated, complementary, once-daily, oral therapy for patients with ‘statin intolerance’ and other high-risk patient populations with hypercholesterolemia.”
Disclosure: Mayleben is an employee of Esperion Therapeutics.