Peptide Graded

Enlicitide

Does Enlicitide work?

Yes, in large controlled trials, including one of 2,909 adults.

AStrong human evidenceFDA approvedas of 2026-10-27

Approval rests on the CORALreef phase 3 program of randomized, double-blind, placebo-controlled trials. CORALreef Lipids (n=2,909) showed a 56% placebo-adjusted LDL reduction at 24 weeks, and CORALreef HeFH showed 59% in familial hypercholesterolemia. The endpoint is a surrogate, LDL cholesterol, but it is a validated one for this drug class, and the outcomes trial is ongoing. 13

CORALreef Lipids randomized 2,909 adults to enlicitide or placebo for 52 weeks. All had established cardiovascular disease or a high risk of it, and 97% took statins. At week 24, LDL cholesterol was 55.8% lower than placebo in the main analysis. A post hoc analysis dropped biologically implausible baseline LDL values. In that analysis, the drop from baseline was about 60%. Non-HDL cholesterol, apolipoprotein B and lipoprotein(a) also fell significantly. The drops held through week 52. Rates of adverse events, including serious ones, did not differ meaningfully from placebo. 1

CORALreef HeFH studied adults with heterozygous familial hypercholesterolemia. It found a 59% LDL drop beyond placebo at week 24. CORALreef AddOn randomized 301 statin-treated adults for eight weeks. They got enlicitide, ezetimibe, bempedoic acid or the last two together. LDL fell 64.6% with enlicitide. It fell 27.8% with ezetimibe, 6.3% with bempedoic acid and 36.5% with the combination. 34

Evidence checklist

  • Randomised controlled trial CORALreef, placebo-controlled phase 3
  • Human study over 100 people CORALreef Lipids, 2,909 adults
  • More than one research group Phase 3 program run by the sponsor
  • Clinical outcomes, not surrogate markers LDL cholesterol only; outcomes trial ongoing
  • Human safety data beyond case reports 52-week adverse events matched placebo

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More on Enlicitide

Citations

  1. Ballantyne 2026, NEJM: oral PCSK9 inhibitor enlicitide in adults with hypercholesterolemia (CORALreef Lipids) doi.org
  2. Merck 2026: Lipfendra (enlicitide) prescribing information merck.com
  3. Merck 2026: Lipfendra approved by the FDA as the first oral PCSK9 inhibitor merck.com
  4. Journal of the American College of Cardiology 2026: enlicitide phase 3 report (DOI record) doi.org
  5. FDA: Novel Drug Approvals for 2026 fda.gov

Reference information only, not medical advice. Drawn from the Enlicitide article, fact-checked against the cited sources. No dosing anywhere on this site.