- Enlicitide decanoate reduced LDL-C by 59.4% at week 24 in the CORALreef HeFH trial.
- The trial involved 303 participants with HeFH on stable lipid-lowering therapy.
- Enlicitide's safety profile was comparable to placebo, with low discontinuation rates.
- Merck plans to share trial data with regulatory authorities worldwide.
Trial Results
Enlicitide decanoate, an investigational oral PCSK9 inhibitor, demonstrated a significant reduction in LDL-C levels by 59.4% at week 24 in adults with heterozygous familial hypercholesterolemia (HeFH) during the Phase 3 CORALreef HeFH trial. The trial results were presented at the AHA Scientific Sessions 2025 and published in the Journal of the American Medical Association.
Study Details
The CORALreef HeFH trial was a randomized, double-blind, placebo-controlled study involving 303 participants with HeFH. Participants were on stable lipid-lowering therapy, including moderate or high-intensity statins. They were randomized 2:1 to receive either 20 mg of enlicitide orally once daily or a placebo.
Safety and Efficacy
Enlicitide showed a safety profile comparable to placebo, with low discontinuation rates due to adverse events. The study also reported statistically significant reductions in non-HDL-C, ApoB, and Lp(a) at week 24. High adherence to the study intervention and dosing instructions was observed across treatment groups.
Future Plans
Merck plans to share data from this trial, along with data from other CORALreef studies, with regulatory authorities worldwide. The company aims to advance enlicitide's clinical development program to address the growing cardiovascular epidemic.
