A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017/CORALreef HeFH)

Summary

The goal of this study is to evaluate the efficacy, safety, and tolerability of enlicitide decanoate in adult participants with heterozygous familial hypercholesterolemia. The primary hypothesis is that enlicitide decanoate is superior to placebo on mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24.

Timeline

Start

2023-08-08

Primary completion

2025-04-07

Completion

2025-04-07

Outcome

Met primary endpoint

registry analysis (superiority test); Enlicitide Decanoate vs Placebo; p <0.001; Difference in Means -59.4 (95% CI -65.6 to -53.2); ANCOVA NCT05952869 ↗

release “CORALreef HeFH: statistically significant and clinically meaningful reductions in LDL-C for enlicitide versus placebo” merck.com ↗

release “The CORALreef HeFH and CORALreef AddOn trials successfully met their primary and all key secondary endpoints” merck.com ↗

release “In CORALreef HeFH, enlicitide demonstrated statistically significant and clinically meaningful reductions in LDL-C at week 24 (primary endpoint)” msd.com ↗

release “CORALreef HeFH試験では、LIPFENDRA®は24週時において、LDL-Cをプラセボと比較して59%低下させました。” msd.co.jp ↗

Publications

• Results Ballantyne CM, Gellis L, Tardif JC, Banka P, Navar AM, Asprusten EA, Scott R, Stroes ESG, Froman S, Mendizabal G, Wang F, Catapano AL. Efficacy and Safety of Oral PCSK9 Inhibitor Enlicitide in Adults With Heterozygous Familial Hypercholesterolemia: A Randomized Clinical Trial. JAMA. 2026 Jan 13;335(2):129-139. doi: 10.1001/jama.2025.20620.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Enlicitide	Unknown	20 mg	Oral

Indications