A recent phase three clinical trial published in The New England Journal of Medicine has reported promising results for an experimental oral medication called enlicitide, which significantly reduced low-density lipoprotein (LDL) cholesterol by approximately 60%. If approved by the Food and Drug Administration (FDA), enlicitide could provide a new alternative for millions of Americans looking to lower their risk of heart attacks and strokes.
Dr. Ann Marie Navar, a cardiologist and lead investigator of the study at UT Southwestern Medical Center, highlighted the potential of enlicitide to enhance the management of LDL cholesterol levels, particularly for patients with atherosclerotic cardiovascular disease, where less than half currently meet recommended cholesterol targets. Traditionally, LDL cholesterol is associated with an increased risk of cardiovascular issues due to its tendency to accumulate in artery walls, leading to blockages.
Enlicitide operates by targeting the PCSK9 protein, similar to existing injectable treatments that lower LDL cholesterol but with the advantage of being an oral medication taken once daily. This may address some barriers associated with the less frequently prescribed injectable options, which can involve higher costs and require patients to manage injections.
The trial involved 2,909 participants, many of whom were already on statin therapies. After 24 weeks, those taking enlicitide exhibited marked reductions in LDL cholesterol and additional cardiovascular risk markers. The study suggests that enlicitide may represent a significant advancement in oral cholesterol-lowering treatments since the introduction of statins.
Looking ahead, further clinical trials are planned to assess whether the reductions in cholesterol achieved with enlicitide will translate into a decreased incidence of heart attacks and strokes. The study was funded by Merck Sharp & Dohme, and Dr. Navar has disclosed consulting fees from Merck related to this research.