Overview
- Enlicitide cut LDL cholesterol by about 56% at 24 weeks in the CORALreef Lipids Phase 3 trial, with reductions approaching 60% in some analyses and remaining roughly 48% to 52% at one year.
- A separate Phase 3 study in heterozygous familial hypercholesterolemia showed about a 59% LDL reduction at 24 weeks versus placebo, with effects sustained through 52 weeks.
- Safety findings were comparable to placebo, including similar rates of serious adverse events (10% vs. 12%) and low discontinuations, and investigators reported improvements in non‑HDL cholesterol, ApoB and Lp(a).
- The main trial enrolled 2,912 adults across 14 countries, most already on statins and some on ezetimibe, and evaluated once‑daily oral dosing of the investigational PCSK9 inhibitor.
- An outcomes trial is ongoing to determine whether LDL lowering with enlicitide reduces heart attacks and strokes, and analysts note potential adherence considerations such as fasting requirements around dosing.