Merck's Enlicitide Hits Phase 3 Goals in CORALreef Lipids Trial

Merck announced today positive topline data from its phase 3 CORALreef Lipids trial of enlicitide, an investigational oral PCSK9 inhibitor, in adults with hypercholesterolemia. 

The once-daily regimen achieved all primary and key secondary endpoints, demonstrating statistically significant reductions from baseline at Week 24 versus placebo in low density lipoprotein cholesterol (LDL-C), non-HDL-C, apolipoprotein B (ApoB), and lipoprotein(a) [Lp(a)]. Safety data were consistent across treatment groups, with low discontinuation rates in trial participants.

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The trial, the largest phase 3 enlicitide study to date, enrolled adult patients with elevated LDL-C and either a history of or high risk for atherosclerotic cardiovascular disease (ASCVD), and were all on statins or marked as statin-intolerant.  Further data from the trial will be communicated to global regulatory agencies, and presented at a future scientific congress.

“This is the third phase 3 trial to demonstrate clinically meaningful and statistically significant LDL-C lowering for enlicitide,” said Dr. Dean Y. Li, president, Merck Research Laboratories. 

The CORALreef program, which includes the active OUTCOMES trial with 14,500 patients enrolled, continues to explore how the therapy reduces cardiovascular risk. Unlike injectable PCSK9 monoclonal antibodies, enlicitide gives patients a new orally administered form that could help more patients reach guideline-recommended lipid targets.

“These data add to the growing body of evidence supporting the safety and efficacy profile of enlicitide to lower LDL cholesterol and other key atherogenic lipids including ApoB and Lp(a),” said Dr. Ann Marie Navar, a lead trial investigator of the study and Associate Professor of Medicine in the Division of Cardiology at UT Southwestern Medical Center.