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Richard Keller: Efficacy and Safety of Enlicitide in High-Risk ASCVD Patients
Richard Keller/LinkedIn
Feb 17, 2026, 14:33

Richard Keller: Efficacy and Safety of Enlicitide in High-Risk ASCVD Patients

Richard Keller, Independent Contractor, Forensic Medical Reviewer and Physician Advisor Physician Advisor at CommonSpirit Health, shared a post on LinkedIn about a recent article by Ann Marie Navar  et al. published in The New England Journal of Medicine:

“Hot off the press!

Another landmark study in drug development for lipid-lowering therapy: the CORALreefLipids Trial. A phase 3 randomized, double-blind, placebo-controlled study of the efficacy and safety of enlicitide, an oral macrocyclic peptide that inhibits the binding of PCSK9 to the LDL receptor, in the treatment of patients who have established ASCVD, or who are at high risk for a first ASCVD event, and an elevated LDL (not at goal).

  • 58.3% of all participants had a previous major ASCVD event. At baseline, 96.6 % of all participants were on treatment with a statin (95.4% on moderate or high intensity dosages). The mean LDL-C in the enlicitide group was 95 ± 38.8 mg/dL (not at goal) and 98.3 ± 39.2 mg/dL in the placebo group (not at goal).
  • The primary endpoint, the mean percent change in LDL-C from baseline to week 24, was -57.1% in the enlicitide group and 3% in the placebo group. This reduction was sustained through week 52 (a key secondary endpoint).
  • Other secondary end points: The mean percent change in non-HDL-C from baseline to week 24: -53.4%. That for apoB, -50.3%. And that for lipoprotein (a), -28.2%.
  • The percentage of patients who reached their guideline-recommended targets for LDL-C was greater in the enlicitide group. 67.5% in the enlicitide group achieved an LDL-C < 55 mg/dL at week 24, compared to placebo. And 70.3% in the enlicitide group achieved an LDL-C < 70 mg/dL at week 24, compared to placebo.
  • Safety outcomes were comparable between the enlicitide and placebo groups.
  • The degree of lowering of multiple atherogenic lipid indices with enlicitide was comparable/greater than currently FDA-approved drug therapies targeting PCSK9 (e.g., monoclonal antibodies, small interfering RNA) and greater than with bempedoic acid and ezetimibe.
  • A dedicated cardiovascular outcomes trial with enlicitide is in progress.

Overall, these results are spectacular and strongly support the use of enlicitide for the treatment of patients with ASCVD (or at high risk for a first ASCVD event) who are unable to meet their LDL-C goals with currently approved drug therapies.”

Title: A Placebo-Controlled Trial of the Oral PCSK9 Inhibitor Enlicitide

Authors: Ann Marie Navar, Elina Mikhailova, Alberico L. Catapano, Puja Banka, Dirk J. Blom, Alberto Cadena, Susan Kourpanidis, Norman E. Lepor, Kazuhisa Tsukamoto, Geraldine Mendizabal, Julio Nunez, Wenjuan Zhang, Pengfei Zhu, D.Phil., Min Zhuo, Christie M. Ballantyne

Richard Keller: Efficacy and Safety of Enlicitide in High-Risk ASCVD Patients

Find the latest updates on Hemostasis Today.

Alberico L Catapano Alberto Cadena Ann Marie Navar Christie M. Ballantyne D.Phil. Dirk J. Blom Elina Mikhailova enlicitide Geraldine Mendizabal Health Hematology Hemostasis Hemostasis News Hemostasis Today Julio Nunez Kazuhisa Tsukamoto Medicine Min Zhuo Norman E. Lepor Oral PCSK9 Inhibitor Pengfei Zhu Puja Banka Susan Kourpanidis The New England Journal of Medicine Wenjuan Zhang
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