Phase 3 Trial Shows Enlicitide Reduces LDL Cholesterol by 60%
A phase 3 trial shows that the oral drug enlicitide reduces LDL cholesterol by 60% compared to placebo, according to results published in the New England Journal of Medicine. Sponsored by Merck & Co., the trial involved 2,909 participants with atherosclerosis or at risk. If approved, enlicitide could help lower heart attack and stroke risk.
A phase 3 clinical trial has found that the experimental cholesterol-lowering drug enlicitide reduces low-density lipoprotein (LDL) cholesterol levels by 60% compared to a placebo, according to findings published in the New England Journal of Medicine. The study, sponsored by Merck & Co. Inc., tested enlicitide in 2,909 individuals with established atherosclerosis or at risk of developing it. Two-thirds of participants received the drug, while the rest received a placebo. After 24 weeks, those taking enlicitide had LDL cholesterol levels about 60% lower than the placebo group.
Enlicitide is a monoclonal antibody that can be taken daily in pill form. It works by attaching to the PCSK9 protein in the bloodstream, which reduces the liver's ability to clear LDL cholesterol from the blood. This mechanism is based on the observation that some people naturally have lower LDL cholesterol due to genetic variants that lead to unusually low levels of PCSK9. Other cardiovascular biomarkers, including apolipoprotein B, non-HDL lipoprotein cholesterol, and lipoprotein(a), were also reduced.
"These reductions in LDL cholesterol are the most we have ever achieved with an oral drug by far since the development of statins," said a cardiologist and associate professor at UT Southwestern Medical Center. If the drug receives approval from the Food and Drug Administration, it could help individuals significantly reduce their risk of heart attacks or strokes. Another clinical trial is underway to determine whether these reductions in LDL cholesterol translate into a reduced risk of heart attacks and strokes.