Is Enlicitide safe?
52-week adverse events matched placebo
AStrong human evidenceFDA approvedas of 2026-10-27
In CORALreef Lipids, about the same share of people on enlicitide and placebo had adverse events and serious adverse events over 52 weeks. In the familial hypercholesterolemia trial, diarrhea and dizziness were common. The label says to take the tablet on an empty stomach, because food cuts absorption. Safety beyond one year, and safety in pregnancy, have not been established. 12
More on Enlicitide
Citations
- Ballantyne 2026, NEJM: oral PCSK9 inhibitor enlicitide in adults with hypercholesterolemia (CORALreef Lipids) doi.org
- Merck 2026: Lipfendra (enlicitide) prescribing information merck.com
- Merck 2026: Lipfendra approved by the FDA as the first oral PCSK9 inhibitor merck.com
- Journal of the American College of Cardiology 2026: enlicitide phase 3 report (DOI record) doi.org
- 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.