US pharmaceutical company Merck & Co Inc (NYSE:MRK), known as MSD outside the US and Canada, announced on Tuesday that its investigational oral PCSK9 inhibitor, enlicitide decanoate, met all primary and key secondary endpoints in the Phase 3 CORALreef Lipids trial for adults with hypercholesterolemia.

The once-daily therapy demonstrated statistically significant and clinically meaningful reductions in LDL cholesterol compared to placebo at 24 weeks.

The trial also showed improvements across secondary endpoints, including reductions in non-HDL cholesterol, apolipoprotein B, and lipoprotein(a). Enlicitide had a favourable safety profile, with adverse event and discontinuation rates comparable to placebo.

Hypercholesterolemia affects an estimated 86 million US adults and is a key driver of atherosclerotic cardiovascular disease, which accounts for 85% of cardiovascular deaths. Nearly 70% of patients with ASCVD do not achieve target LDL cholesterol levels despite treatment with statins.

Merck said that CORALreef Lipids is the largest Phase 3 study completed to date evaluating enlicitide in patients with elevated LDL cholesterol at risk for major cardiovascular events. The company plans to present the data at an upcoming scientific congress and engage regulators worldwide.