Merck Announces Positive Results from Phase 3 CORALreef Lipids Trial for Enlicitide Decanoate

Merck & Co. has announced positive topline results from the Phase 3 CORALreef Lipids trial evaluating enlicitide decanoate, a PCSK9 inhibitor for hypercholesterolemia on statin intolerance. The trial met all primary and key secondary endpoints, showing significant reductions in LDL-C, non-HDL cholesterol, ApoB, and Lp(a) compared to placebo. Adverse events and discontinuations were low and comparable between groups. Merck plans to share the results with regulatory authorities and present them at a future scientific congress.

Merck & Co. (NYSE: MRK) has announced positive topline results from the Phase 3 CORALreef Lipids trial, evaluating enlicitide decanoate, a novel oral PCSK9 inhibitor for hypercholesterolemia in patients with statin intolerance. The trial successfully met all primary and key secondary endpoints, demonstrating significant reductions in low-density lipoprotein cholesterol (LDL-C), non-HDL cholesterol, apolipoprotein B (ApoB), and lipoprotein(a) [Lp(a)] compared to placebo [1].

Enlicitide decanoate, an investigational, once-daily oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, showed statistically significant and clinically meaningful reductions in LDL-C at Week 24. The trial also met key secondary endpoints, including changes from baseline in non-HDL-C, ApoB, and Lp(a) at Week 24 [1].

The safety profile of enlicitide decanoate was favorable, with comparable rates of adverse events (AEs) and serious adverse events (SAEs) between treatment groups. Discontinuations due to AEs were low and comparable between groups [1].

The CORALreef Lipids trial represents the largest completed Phase 3 study evaluating enlicitide in a broad range of participants with elevated LDL-C and a history of or increased risk for major atherosclerotic cardiovascular disease events despite treatment with at least a moderate or high intensity statin (or with documented statin intolerance) [1].

Merck plans to share these results with regulatory authorities worldwide and will present the data at a future scientific congress. If approved, enlicitide decanoate has the potential to change the way LDL levels are managed, providing a new oral option for patients to achieve treatment goals [1].

References:
[1] https://www.morningstar.com/news/business-wire/20250902024418/mercks-investigational-oral-pcsk9-inhibitor-enlicitide-decanoate-met-all-primary-and-key-secondary-endpoints-in-adults-with-hypercholesterolemia-in-pivotal-coralreef-lipids-study