Merck Reports Positive Phase 3 Data For Enlicitide In Treatment For Hyperlipidemia

Merck, also known as MSD outside the U.S. and Canada, announced positive topline results from two Phase 3 trials, CORALreef HeFH and CORALreef AddOn, evaluating enlicitide decanoate, its investigational oral PCSK9 inhibitor. The trials successfully met all primary and key secondary endpoints, showing statistically significant and clinically meaningful reductions in LDL-C (bad cholesterol) in adults already receiving statin therapy.

“We are thrilled to bring forward the first Phase 3 results from our clinical development program evaluating enlicitide, which, if approved, would be the first marketed oral PCSK9 inhibitor in the U.S. Enlicitide is a novel macrocyclic peptide that has the potential to deliver antibody-like efficacy and specificity for the validated PCSK9 mechanism in the form of a daily oral pill. We are working with urgency to make this oral therapy available to patients worldwide,” said Dr. Dean Y. Li, president, Merck Research Laboratories. 

In the CORALreef HeFH study, enlicitide significantly outperformed placebo in reducing LDL-C levels in adults with heterozygous familial hypercholesterolemia (HeFH) at risk for atherosclerotic cardiovascular disease (ASCVD). In the CORALreef AddOn trial, enlicitide also demonstrated greater LDL-C reductions compared to oral non-statin therapies such as ezetimibe and bempedoic acid. Importantly, no clinically meaningful differences in adverse events or serious adverse events were observed.

“Atherosclerotic cardiovascular disease accounts for 85 percent of cardiovascular deaths. Despite available treatment options, cardiovascular-related deaths remain the leading cause of death worldwide and continue to rise. LDL-C is a major modifiable risk driver for atherosclerosis and prioritization of LDL-C management should be a cornerstone of cardiovascular risk prevention. Early intervention and intensification of lipid treatment would allow more patients to achieve LDL-C goals,” said Dr. Christie M. Ballantyne, principal investigator of the CORALreef HeFH study and Professor of Medicine at Baylor College of Medicine. 

These studies are part of the broader CORALreef Phase 3 clinical development program, which will include data from approximately 17,000 patients globally. Results from all three Phase 3 trials will be shared at an upcoming scientific conference.