Merck Touts Strong Comparator Data for Enlicitide Decanoate, Oral PCSK9 Inhibitor Reducing LDL-C by Up to 60% in Phase 3 Trials

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Merck's investigational oral PCSK9 inhibitor enlicitide decanoate reduced LDL-C by 59.4% vs placebo at week 24 in Phase 3 CORALreef HeFH trial for adults with HeFH, presented at AHA 2025 and published in JAMA.1

In Phase 3 CORALreef Lipids trial, enlicitide reduced LDL-C by 55.8%-59.7% vs placebo at week 24 in patients with or at-risk for ASCVD, also presented at AHA 2025.2

Enlicitide matches efficacy of injectable PCSK9 inhibitors with a placebo-comparable safety profile, potentially first approved oral option.12

Results from CORALreef trials published in NEJM in early 2026, highlighting up to 60% LDL-C reductions.345

Ongoing CORALreef Outcomes trial with over 14,500 participants evaluates CV event reduction; additional trials in pediatrics and combinations.1

Sources:

1. https://www.merck.com/news/mercks-enlicitide-decanoate-an-investigational-oral-pcsk9-inhibitor-significantly-reduced-ldl-c-in-adults-with-heterozygous-familial-hypercholesterolemia-hefh-in-phase-3-coralreef-hefh-tr/

2. https://www.merck.com/news/mercks-enlicitide-decanoate-an-investigational-oral-pcsk9-inhibitor-significantly-reduced-ldl-c-in-phase-3-coralreef-lipids-trial/

3. https://www.sciencedaily.com/releases/2026/03/260321012659.htm

4. https://www.powershealth.org/about-us/newsroom/health-library/2026/02/09/experimental-pill-slashes-bad-cholesterol-levels

5. https://www.utsouthwestern.edu/newsroom/articles/year-2026/feb-experimental-pill-bad-cholesterol.html