A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-013) CORALreef Lipids

Phase 3 Completed 2912 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupTriple-blindTreatment

Summary

The goal of this study is to evaluate the efficacy, safety, and tolerability of enlicitide decanoate in adult participants with 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: 2023-08-10
Primary completion: 2025-07-28
Completion: 2025-07-28

Outcome

Met primary endpoint

paper The mean percent change in LDL cholesterol levels at week 24 was -57.1% (95% confidence interval [CI], -61.8 to -52.5) with enlicitide and 3.0% (95% CI, 0.9 to 5.1) with placebo PMID 41879224 ↗

release “The CORALreef Lipids trial successfully met all primary and key secondary endpoints.” merck.com ↗

Publications

Navar AM, Mikhailova E, Catapano AL, Banka P, Blom DJ, Cadena A, Kourpanidis S, Lepor NE, Tsukamoto K, Mendizabal G, Nunez J, Zhang W, Zhu P, Zhuo M, Ballantyne CM; CORALreef Lipids Investigators. A Placebo-Controlled Trial of the Oral PCSK9 Inhibitor Enlicitide. N Engl J Med. 2026 Feb 5;394(6):529-539. doi: 10.1056/NEJMoa2511002.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Enlicitide Decanoate	Unknown	20 mg	Oral