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# Merck PCSK9 Inhibitor Meets Trial Goals
- URL: https://www.fdaweb.com/merck-pcsk9-inhibitor-meets-trial-goals/
- Published: 2025-09-02T12:00:00.000Z
- Updated: 2026-09-14T15:20:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159792

Merck’s investigational oral PCSK9 inhibitor enclicitide decanonate met all its primary and secondary endpoints in the Phase 3 CORALreef Lipids trial evaluating the drug to treat adults with hypercholesterolemia on a moderate or high-intensity statin. A company [statement](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/?ref=fdaweb.com) says treatment with enlicitide resulted in statistically significant and clinically meaningful reduction in LDL (low-density lipoprotein) cholesterol compared to placebo at week 24\. The company says that discontinuations due to adverse events were low and comparable between treatment groups.

Enlicitide is described as a potentially first oral PCSK9 inhibitor designed to lower LDL cholesterol through the same biological mechanism as currently approved monoclonal antibody, injectable PCSK9 inhibitors, but in a daily pill form. It is said to be a novel small molecule macrocyclic peptide that binds to PCSK9 and inhibits the interaction of PCSK9 with LDL receptors.