Enlicitide decanoate is an investigational once-daily oral PCSK9 inhibitor in late-stage development for hypercholesterolemia, including heterozygous familial hypercholesterolemia. Phase 3 data showed large LDL-C reductions versus placebo with similar overall safety profile in reported studies. The therapy remains unapproved and under regulatory review.
A phase 3 trial shows that the oral drug enlicitide reduces LDL cholesterol by 60% compared to placebo, according to results published in the New England Journal of Medicine. Sponsored by Merck & Co., the trial involved 2,909 participants with atherosclerosis or at risk. If approved, enlicitide could help lower heart attack and stroke risk.
Trump secured agreements with 16 pharmaceutical companies tied to TrumpRx.gov, including most-favoured-nation pricing and direct-to-patient discounts. Several companies disclosed price cuts for obesity, diabetes, insulin and other medicines.
Merck will present late-breaking clinical data from its cardio-pulmonary pipeline at ACC.26, including positive Phase 3 results for enlicitide, an investigational oral PCSK9 inhibitor, and Phase 2 data for WINREVAIR in heart failure patients.
Enlicitide decanoate demonstrated efficacy in reducing LDL cholesterol levels compared to placebo in patients with atherosclerotic cardiovascular disease history or risk, according to phase 3 CORALreef Lipids trial data.
Barclays initiated coverage on Merck with an overweight rating and $140 price target, citing expected product launches including enlicitide and pivotal trial readouts for tulisokibart in 2026.
A phase three clinical trial shows enlicitide, an oral monoclonal antibody, reduced LDL cholesterol by 60% compared to placebo in 2,909 patients with or at risk of atherosclerosis over 24 weeks.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07614984 |
A Clinical Trial of MK-7262 and Enlicitide in Participants With High Lipoprotein(a) (MK-7262-004) |
NOT_YET_RECRUITING | PHASE2 |
| NCT07481708 |
A Clinical Study of the Effect of Enlicitide (MK-0616) Formulations in Healthy Participants (MK-0616-041) |
ACTIVE_NOT_RECRUITING | PHASE1 |
| NCT07300280 |
A Clinical Trial of Enlicitide and Rosuvastatin in Healthy Adults (MK-0616-039) |
RECRUITING | PHASE1 |
| NCT07216482 |
A Clinical Study of Enlicitide in Participants With High Cholesterol (MK-0616-037) |
RECRUITING | PHASE3 |
| NCT07044479 |
A Clinical Study of How Coffee and Tea Affect Enlicitide in Healthy Volunteers (MK-0616-040) |
COMPLETED | PHASE1 |
| NCT06880874 |
A Clinical Study to Evaluate Enlicitide (MK-0616) Formulations in Healthy Adult Participants (MK-0616-035) |
COMPLETED | PHASE1 |
| NCT06719544 |
A Study of Lithium and Enlicitide in Healthy Adult Participants (MK-0616-034) |
COMPLETED | PHASE1 |
| NCT06643377 |
A Clinical Study of Enlicitide in Participants With Severe Renal Impairment (MK-0616-032) |
COMPLETED | PHASE1 |
| NCT06609512 |
A Clinical Study of Enlicitide and the Effect of Food in Healthy Adult Participants (MK-0616-033) |
COMPLETED | PHASE1 |
| NCT06597760 |
A Clinical Study to Assess the Effect of Enlicitide on How the Body Processes Digoxin in Healthy Adult Participants (MK-0616-031) |
COMPLETED | PHASE1 |
