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Merck’s Oral PCSK9 Pill Cuts LDL Up to 60% in Phase 3, Matching Injectable Therapies

Regulatory review is planned for early 2026, pending results from a 14,500‑plus outcomes study on heart attack and stroke prevention.

Overview

  • At the AHA Scientific Sessions, enlicitide reduced LDL cholesterol by about 56% at 24 weeks in a 2,912‑patient Phase 3 trial, with effects largely sustained to one year.
  • In a separate study of heterozygous familial hypercholesterolemia (n≈303), LDL reductions reached roughly 59% at 24 weeks and remained about 61.5% lower than placebo at one year.
  • Safety findings showed similar serious adverse event rates versus placebo (10% vs 12%) and low discontinuation due to side effects (3% vs 4%).
  • Investigators reported comparable improvements in non‑HDL cholesterol, ApoB, and Lp(a), with LDL‑lowering described as nearly identical to that seen with PCSK9 antibody injections.
  • Merck is positioning the once‑daily pill as a convenient, potentially lower‑cost alternative to injectables, though practical use may be influenced by a short fasting requirement noted by analysts.