Overview
- The late-stage data presented at the American Heart Association meeting showed roughly 56% LDL-C reduction at 24 weeks in a 2,912-patient study, with a 48% drop sustained at one year.
- In a separate 303-participant trial of heterozygous familial hypercholesterolemia, the therapy delivered a 61.5% LDL-C reduction versus placebo at one year.
- Participants were largely on statins, and the once-daily oral agent targets PCSK9 like Repatha and Praluent but could be easier to use and store.
- Merck says it will share the Phase 3 results with regulators, and multiple reports indicate an FDA filing is planned for early 2026.
- An outcomes trial testing reductions in heart attacks and strokes is ongoing, and analysts note a brief fasting window around dosing could challenge adherence.