A Study to Evaluate the Efficacy and Safety of Enlicitide (MK-0616, Oral PCSK9 Inhibitor) Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia (MK-0616-018/CORALreef AddOn)

Summary

The main purpose of this study is to assess whether enlicitide is superior to ezetimibe or bempedoic acid or ezetimibe + bempedoic acid in reducing low-density lipoprotein cholesterol (LDL-C) in participants with hypercholesterolemia, and to evaluate its safety and tolerability. The primary study hypotheses are enlicitide is superior to ezetimibe, bempedoic acid, and ezetimibe + bempedoic acid on mean percent change from baseline in LDL-C at week 8.

Timeline

Start

2024-07-08

Primary completion

2025-02-14

Completion

2025-03-28

Publications

• Catapano AL, Mikhailova E, Navar AM, Banka P, Corral P, Saxena M, Steg PG, Verma S, Kordahi AY, Mendizabal G, Zhu P, Ballantyne CM; CORALreef AddOn Investigators. Oral PCSK9 Inhibitor Enlicitide Versus Oral Nonstatin Therapies: A Phase 3 Randomized Clinical Trial. J Am Coll Cardiol. 2026 Mar 30:S0735-1097(26)05832-8. doi: 10.1016/j.jacc.2026.03.036. Online ahead of print.

Drugs

Indications