Baylor College of…

Houston, TX - Jul 17, 2026

Share this article

Baylor College of Medicine researchers played a key role in the clinical development of the first oral PCSK9 inhibitor approved by the U.S. Food and Drug Administration. This novel therapy reduces LDL cholesterol, the bad cholesterol, in adults with hypercholesterolemia, including those with the inherited genetic disorder heterozygous familial hypercholesterolemia (HeFH).

The approval of LIPFENDRA® (enlicitide), developed by Merck, is based on two Phase 3 trials from the CORALreef clinical program: CORALreef Lipids and CORALreef HeFH. This global research effort helped to evaluate the new cholesterol-lowering therapy.

Dr. Christie M. Ballantyne, professor and director of the Center for Cardiometabolic Disease Prevention at Baylor, was the principal investigator for the CORALreef HeFH trial and senior author on the CORALreef Lipids study. The approval marks an important advance for patients who need additional LDL-C lowering despite current therapies, he said.

"Cardiovascular disease remains the leading cause of pain, suffering and death in the U.S., and high levels of LDL cholesterol are a major contributor to this disease," said Ballantyne, who also is the section chief of cardiology and cardiovascular research at Baylor. "Unfortunately, high cholesterol has no symptoms, making it critical to have your cholesterol tested. We still see the majority of high-risk individuals are not achieving the optimal levels of LDL cholesterol."

In the Phase 3 trials, enlicitide reduced LDL-C by 56% in high-risk adults with hypercholesterolemia and by 59% in adults with HeFH compared with placebo after 24 weeks of treatment. The studies also demonstrated significant reductions in other atherogenic lipoproteins, such as lipoprotein (a), associated with cardiovascular risk.

"Hopefully, the availability of a new oral PCSK9 inhibitor will provide a simpler treatment option for both healthcare providers and patients to manage an otherwise asymptomatic condition," Ballantyne said. "People are already accustomed to taking a daily pill for conditions like high blood pressure, and this new oral therapy may help more patients achieve their optimal LDL cholesterol levels."

Ballantyne adds that the most important aspect of treating cardiovascular disease is knowing your cholesterol and blood pressure numbers and working with your healthcare provider to determine health goals and treatments that are right for you.