Merck’s investigational oral PCSK9 inhibitor, enlicitide decanoate, met all primary and key secondary endpoints in the pivotal Phase 3 CORALreef Lipids trial for adults with hypercholesterolemia13.
Enlicitide demonstrated statistically significant and clinically meaningful reductions in low-density lipoprotein cholesterol (LDL-C) compared to placebo at 24 weeks13.
Secondary endpoints, including reductions in non-HDL cholesterol, apolipoprotein B (ApoB), and lipoprotein(a) (Lp(a)), were also achieved with statistical and clinical significance1.
The safety profile of enlicitide was favorable, with rates of adverse events and treatment discontinuation comparable to placebo13.
This marks the third consecutive successful Phase 3 result for enlicitide in the CORALreef program, supporting regulatory discussions to potentially make enlicitide the first approved oral PCSK9 inhibitor34.
Enlicitide is designed for once-daily oral dosing and targets patients on moderate or high-intensity statins or with statin intolerance15.
Sources:
1. https://www.merck.com/news/mercks-investigational-oral-pcsk9-inhibitor-enlicitide-decanoate-met-all-primary-and-key-secondary-endpoints-in-adults-with-hypercholesterolemia-in-pivotal-coralreef-lipids-study/
3. https://www.fiercebiotech.com/biotech/merck-dives-regulatory-talks-after-oral-pcsk9-surfaces-third-phase-3-win
4. https://druganddeviceworld.com/2025/06/10/merck-reports-positive-phase-iii-results-for-oral-pcsk9-inhibitor/
5. https://en.chingcheng-law.com/news/details.php?id=54945&group_id=10763