Oral PCSK9 Inhibitor

Merck’s Phase 3 CORALreef Lipids trial revealed that enlicitide, an investigational oral PCSK9 inhibitor, significantly reduced LDL-C levels by 55.8% in adults with or at risk for ASCVD. The study demonstrated sustained reductions at one year and improvements in other lipid parameters. Enlicitide’s safety profile was comparable to placebo, with high treatment adherence. The oral formulation may address unmet needs in ASCVD management due to the availability of current injectable PCSK9 inhibitors. Merck plans to seek regulatory approval based on these findings and other CORALreef trials.