Peptide LibraryEnlicitide dosage in published studies and labels
These are the doses used for Enlicitide in FDA labelling and published clinical studies, reported as each source states them, one row per regimen. They describe what was studied or approved for a specific population. They are not a recommendation, and none of them is a dose for any individual.
Research and educational reference only. This is not medical advice, and no figure on this page is a dosing recommendation.
Last checked against primary sources:
Studied regimens and sources
Enlicitide has an FDA-approved human dosage. As Lipfendra, approved in July 2026, it is one 20 mg tablet by mouth once daily on an empty stomach, for adults with high LDL cholesterol, including heterozygous familial hypercholesterolemia. It is taken in the morning with water, black coffee or plain tea, at least 30 minutes before food.
FDA Approved
| Human dosing established | Yes |
|---|---|
| Studied dose range | 20 mg by mouth once daily |
| Route | Oral |
| Frequency | Once daily |
| Duration studied | Continuous |
| Titration | None. The label has a single 20 mg dose. LDL cholesterol can be measured as early as 4 weeks after starting. |
| Half-life | Effective half-life about 14 hours; terminal half-life about 244 hours |
| Evidence level | FDA Approved |
| Last reviewed | 2026-10-30 |
Research-reported dosing
Doses as studied, one row per regimen. Different trials used different regimens; they are listed separately rather than averaged.
| Study / context | Population | Dose | Route | Frequency | Duration | Outcome studied | Source |
|---|---|---|---|---|---|---|---|
| FDA label — LipfendraFDA-approved label · FDA prescribing information | Adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia, as an adjunct to diet and exercise | 20 mg | Oral tablet, swallowed whole on an empty stomach | Once daily, in the morning | Continuous | Reduction of LDL cholesterol | LIPFENDRA (enlicitide) tablets — FDA prescribing information, DailyMed |
| Navar et al., 2026 — CORALreef Lipids, phase 3Clinical trial · Randomised, double-blind, placebo-controlled phase 3 | Adults with a past major atherosclerotic cardiovascular event or at risk of a first one, whose LDL cholesterol stayed above target on lipid-lowering treatment (1,935 on enlicitide, 969 on placebo) | 20 mg | Oral | Once daily | 52 weeks | LDL cholesterol changed by -57.1% at week 24 versus +3.0% on placebo | Navar AM et al. A Placebo-Controlled Trial of the Oral PCSK9 Inhibitor Enlicitide. N Engl J Med. 2026. |
| Ballantyne et al., 2026 — CORALreef HeFH, phase 3Clinical trial · Randomised, placebo-controlled phase 3 | Adults with heterozygous familial hypercholesterolemia on a moderate- or high-intensity statin (202 on enlicitide, 101 on placebo) | 20 mg | Oral | Once daily | 52 weeks | LDL cholesterol changed by -58.2% at week 24 versus +2.6% on placebo | Ballantyne CM et al. Efficacy and Safety of Oral PCSK9 Inhibitor Enlicitide in Adults With Heterozygous Familial Hypercholesterolemia: A Randomized Clinical Trial. JAMA. 2026. |
| Catapano et al., 2026 — CORALreef AddOn, phase 3Clinical trial · Randomised, double-blind, active-comparator phase 3 | Statin-treated adults needing further LDL lowering (101 on enlicitide, 200 on bempedoic acid, ezetimibe or both) | 20 mg | Oral | Once daily | 56 days | LDL cholesterol changed by -64.6% versus -6.3% with bempedoic acid, -27.8% with ezetimibe and -36.5% with both | Catapano AL et al. Oral PCSK9 Inhibitor Enlicitide Versus Oral Nonstatin Therapies: A Phase 3 Randomized Clinical Trial. J Am Coll Cardiol. 2026. |
| Ballantyne et al., 2023 — phase 2b dose-ranging trialClinical trial · Randomised, double-blind, placebo-controlled phase 2b | Adults with hypercholesterolemia across a wide range of cardiovascular risk (n=381) | 6, 12, 18 or 30 mg | Oral | Once daily | 8 weeks | Placebo-adjusted LDL cholesterol change of -41.2% (6 mg), -55.7% (12 mg), -59.1% (18 mg) and -60.9% (30 mg) | Ballantyne CM et al. Phase 2b Randomized Trial of the Oral PCSK9 Inhibitor MK-0616. J Am Coll Cardiol. 2023. |
| Johns et al., 2023 — first phase 1 studiesClinical trial · Phase 1 studies | Healthy adults (single rising doses) and participants on statins (multiple doses) | Single rising doses; 20 mg once daily in the multiple-dose study the abstract reports | Oral | — | 14 days (multiple-dose study) | Free PCSK9 fell by more than 93%; LDL cholesterol fell by up to 61% after 14 days of 20 mg | Johns DG et al. Orally Bioavailable Macrocyclic Peptide That Inhibits Binding of PCSK9 to the Low Density Lipoprotein Receptor. Circulation. 2023. |
| NCT06008756 — CORALreef Outcomes, ongoingClinical trial · Randomised, placebo-controlled phase 3 outcomes trial | Adults at high cardiovascular risk (estimated enrollment 14,550) | 20 mg | Oral | Once daily | — | Major cardiovascular events; no results yet (estimated completion 2031) | NCT06008756 — Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Cardiovascular Outcomes Study (CORALreef Outcomes) |
Preclinical and analog research
Not human dosing evidence. Listed for completeness and never extrapolated to a human dose.
| Study / context | Population | Dose | Route | Frequency | Duration | Outcome studied | Source |
|---|---|---|---|---|---|---|---|
| Preclinical — animal reproduction studiesPreclinical · Animal toxicology reported in the FDA label | Pregnant rats and rabbits | Up to 10 mg/kg/day in rats and 3 mg/kg/day in rabbits; not convertible to a human dose | Subcutaneous | Once daily | — | No adverse embryofetal or maternal effects at these doses, but enlicitide crossed the placenta in rats | LIPFENDRA (enlicitide) tablets — FDA prescribing information, section 8.1, DailyMed |
Where sources disagree
- The placebo-adjusted LDL reduction at week 24 is 56% in the primary analysis (label and NEJM). The label also gives 60% from a post hoc analysis that set LDL values of zero or below to missing, which is the figure some later papers quote.
- The label's cardiovascular statement is about LDL lowering with statins and monoclonal antibody PCSK9 inhibitors, not about enlicitide. Enlicitide's own outcomes trial, CORALreef Outcomes (NCT06008756), has not reported.
- Doses are given as enlicitide: one 20 mg tablet contains 22.21 mg of enlicitide decanoate. The registry entry for the phase 2b trial names enlicitide chloride, so its 6 to 30 mg arms are not the marketed salt.
- Food matters. Taken 30 minutes after a meal, exposure fell by about half (AUC 48%, Cmax 50%), and oral bioavailability is about 1%.
- Safety and effectiveness have not been established in children. A pediatric study is under way (NCT07058077).