MSD has announced positive results from its phase 3 CORALreef Lipids trial, showing that enlicitide decanoate, an investigational oral PCSK9 inhibitor, significantly reduced low-density lipoprotein cholesterol (LDL-C) in adults with high cholesterol.
The once-daily treatment achieved a 55.8% reduction in LDL-C at week 24 compared to placebo. A post-hoc reanalysis confirmed a 59.7% reduction. At week 52, reductions remained statistically significant at 47.6% and 52.4% respectively.
Dean Li, president of MSD Research Laboratories, said: “Enlicitide was designed to deliver PCSK9 antibody-like efficacy and specificity in an oral pill.” He added: “Enlicitide, if approved, could add to physicians’ armamentarium to lower LDL-C.”
The trial enrolled 2,912 participants and is the largest completed phase 3 study of enlicitide. It also showed significant reductions in non-HDL-C, ApoB and Lp(a), with 67.5% of patients achieving a 50% or more reduction in LDL-C and levels below 55 mg/dL at week 24.
Jasveen Chugh, Executive Director and Head of Pharmaceutical Medicines at MSD in the UK, explained: “Cardiovascular disease represents a growing public health threat both globally and within the UK. With ASCVD responsible for approximately 85% of all cardiovascular deaths worldwide, there is a need for new treatment options, and this data represents a promising step forward.”
The safety profile of enlicitide was comparable to placebo, with similar rates of adverse events and discontinuations. The most common treatment-related events were infections, gastrointestinal issues and musculoskeletal disorders.
Enlicitide is not yet licensed in the UK or any other country. MSD plans to present further data from the CORALreef HeFH trial, which focuses on patients with inherited high cholesterol.
