- Enlicitide is the first oral PCSK9 inhibitor to show significant LDL-C reduction in Phase 3 trials.
- The CORALreef Lipids trial met all primary and key secondary endpoints at Week 24.
- Enlicitide demonstrated safety with low and comparable discontinuation rates between groups.
- Merck plans to present trial data at a future scientific congress.
Study Overview
Merck's Phase 3 CORALreef Lipids trial evaluated the safety and efficacy of enlicitide decanoate, an oral PCSK9 inhibitor, for treating adults with hypercholesterolemia. The study focused on patients on moderate or high-intensity statins or those with documented statin intolerance.
Key Findings
The trial successfully met all primary and key secondary endpoints, showing statistically significant and clinically meaningful reductions in low-density lipoprotein cholesterol (LDL-C) compared to placebo at Week 24. Enlicitide also demonstrated significant reductions in non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB), and lipoprotein(a) [Lp(a)].
Safety Profile
Enlicitide exhibited a favorable safety profile, with no clinically meaningful differences in adverse events, including serious adverse events, between treatment groups. Discontinuations due to adverse events were low and comparable across groups.
Future Plans
Merck intends to share these results with regulatory authorities worldwide and present the data at a future scientific congress. The company is also conducting an ongoing cardiovascular outcomes trial to further evaluate enlicitide's potential in reducing atherosclerotic cardiovascular risk.
