Also known as: MK-0616
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.
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.
Merck stock reached a 52-week high at $122.69, rising 46.25% over 12 months and 7.4% in the past month following strong Q4 results and improved long-term pipeline outlook beyond Keytruda's 2028 patent expiration.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07058077 |
A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029) |
RECRUITING | PHASE2/PHASE3 |
| NCT06772792 |
A Study to Evaluate the Drug-Drug Interaction Between Enlicitide Decanoate (MK-0616) and Alendronate in Healthy Adult Participants (MK-0616-027) |
COMPLETED | PHASE1 |
| NCT06772779 |
A Study of Enlicitide Decanoate (MK-0616), Warfarin, and Lisinopril in Healthy Adult Participants (MK-0616-026) |
COMPLETED | PHASE1 |
| NCT06699355 |
A Study to Evaluate the Drug-Drug Interaction Between Enlicitide Decanoate (MK-0616) and Atorvastatin in Healthy Adult Participants (MK-0616-024) |
COMPLETED | PHASE1 |
| NCT06699329 |
A Study of Enlicitide Decanoate (MK-0616) and Semaglutide in Healthy Adult Participants (MK-0616-023) |
COMPLETED | PHASE1 |
| NCT06691906 |
A Clinical Study of Enlicitide Decanoate (MK-0616) in Healthy Adult Participants (MK-0616-025) |
COMPLETED | PHASE1 |
| NCT06658652 |
The Effect of Food and Water Volume in Healthy Adult Participants Administered Enlicitide Decanoate (MK-0616) (MK-0616-022) |
COMPLETED | PHASE1 |
| NCT06625814 |
A Study of Levothyroxine and Enlicitide Decanoate (MK-0616) in Healthy Adult Participants (MK-0616-028) |
COMPLETED | PHASE1 |
| NCT06492291 |
Open-label Extension Study of Enlicitide Decanoate (MK-0616/Enlicitide Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-019) CORALreef Extension |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT06008756 |
Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Cardiovascular Outcomes Study (MK-0616-015) CORALreef Outcomes |
ACTIVE_NOT_RECRUITING | PHASE3 |
