Phase III Study of Bempedoic Acid Tablets for Adults with Primary Hyperlipidemia Not Controlled by Statins

What this Trial Is About

Researchers are conducting a Phase III clinical trial to study the effects of Bempedoic Acid Tablets in adults with primary hyperlipidemia whose condition is not adequately controlled by statins. The study aims to assess the drugs effectiveness, tolerability, and safety in this patient group. It is sponsored by Gan & Lee Pharmaceuticals and involves a randomized, double-blind design to compare treatments. Participants will be randomly assigned to receive either the Bempedoic Acid Tablet or a placebo, both administered once daily by mouth. The treatment period focuses on a 12-week timeframe to evaluate changes in cholesterol levels. The study includes assessments of LDL-C and total cholesterol levels as key measures, alongside monitoring for any adverse events throughout the trial. During the study, participants will undergo evaluations at baseline and at week 12 to measure cholesterol changes. Safety will be monitored through reports of adverse and serious adverse events up to week 13. The trial requires informed consent and adherence to contraception guidelines for participants of reproductive potential. The total participation length spans at least 13 weeks, including treatment and safety follow-up.

A Clinical Study to Evaluate the Efficacy, Tolerability, and Safety of Bempedoic Acid