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Merck's Oral Cholesterol Pill Cuts LDL by 60% in Trial

Merck’s oral PCSK9 inhibitor enlicitide reduced LDL cholesterol by about 60% after 24 weeks and sustained reductions through one year in a trial of 2,912 adults with or at risk for ASCVD.

  • On Saturday at the American Heart Association meeting, Merck, pharmaceutical company, reported enlicitide reduced LDL by up to 60% after 24 weeks in a phase 3 trial of 2,912 adults.
  • Amid widespread under‑treatment of LDL cholesterol, about 70 patients on lipid‑lowering therapies do not reach guideline goals, and PCSK9 injectables face barriers with list prices over $500 a month.
  • Merck reported that safety signals were similar, with about 10% of enlicitide patients experiencing serious adverse events and Dr. Puja Banka stating `Ultimately, the side effects were balanced between the enlictide arm and the placebo arm`.
  • Merck plans to apply to the US Food and Drug Administration for enlicitide early next year and aims to launch the drug in 2027 while making it affordable to 'democratize PCSK9' access.
  • A larger outcomes study of more than 14,500 people is underway as PCSK9 blockade can reduce heart attacks and strokes by up to 20%, with at least 6 million adults in the United States eligible.
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It's called enlicithide and it'll take one tablet a day to halve Ldl levels. A breakthrough is expected for millions of patients. That's how I work...

·Turin, Italy
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fiercebiotech.com broke the news in on Tuesday, September 2, 2025.
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