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
Outcome
Met primary endpoint
registry analysis (superiority test); Enlicitide vs Bempedoic Acid; p <0.001; Difference in Means -56.7 (95% CI -64.3 to -49.0); ANCOVA NCT06450366 ↗
registry analysis (superiority test); Enlicitide vs Ezetimibe; p <0.001; Difference in Means -36.0 (95% CI -41.8 to -30.2); ANCOVA NCT06450366 ↗
registry analysis (superiority test); Enlicitide vs Ezetimibe + Bempedoic Acid; p <0.001; Difference in Means -28.1 (95% CI -33.6 to -22.6); ANCOVA NCT06450366 ↗
release “CORALreef AddOn: statistically significant and clinically meaningful reductions in LDL-C for enlicitide versus ezetimibe” merck.com ↗
release “The CORALreef HeFH and CORALreef AddOn trials successfully met their primary and all key secondary endpoints” merck.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bempedoic acid | Small molecule | 180 mg | Oral |
| Subject | Enlicitide | Unknown | 20 mg | Oral |
| Comparator | Ezetimibe | Unknown | 10 mg | Oral |