Enlicitide Decanoate

DRUG14 trials

Sponsors

Merck Sharp & Dohme LLC

Conditions

ArteriosclerosisFamilial HypercholesterolemiaHealthyHeterozygous Familial Hypercholesterolemia (HeFH)HypercholesterolaemiaHypercholesterolemiaHyperlipidemia

Phase 1

Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Renal Impairment Study (MK-0616-020)

CompletedNCT05934292

Merck Sharp & Dohme LLCHypercholesterolaemia

Start: 2023-07-20End: 2024-01-19Updated: 2025-02-17

A Study of Levothyroxine and Enlicitide Decanoate (MK-0616) in Healthy Adult Participants (MK-0616-028)

CompletedNCT06625814

Merck Sharp & Dohme LLCHealthy

Start: 2024-07-08End: 2024-09-11Updated: 2024-10-03

The Effect of Food and Water Volume in Healthy Adult Participants Administered Enlicitide Decanoate (MK-0616) (MK-0616-022)

CompletedNCT06658652

Merck Sharp & Dohme LLCHealthy

Start: 2023-10-24End: 2023-12-26Updated: 2024-10-26

A Clinical Study of Enlicitide Decanoate (MK-0616) in Healthy Adult Participants (MK-0616-025)

CompletedNCT06691906

Merck Sharp & Dohme LLCHealthy

Start: 2024-03-18End: 2024-05-01Updated: 2024-11-18

A Study of Enlicitide Decanoate (MK-0616) and Semaglutide in Healthy Adult Participants (MK-0616-023)

CompletedNCT06699329

Merck Sharp & Dohme LLCHealthy

Start: 2024-01-22End: 2024-05-24Updated: 2024-11-21

A Study to Evaluate the Drug-Drug Interaction Between Enlicitide Decanoate (MK-0616) and Atorvastatin in Healthy Adult Participants (MK-0616-024)

CompletedNCT06699355

Merck Sharp & Dohme LLCHealthy

Start: 2023-11-08End: 2023-12-29Updated: 2024-11-21

A Study to Evaluate the Drug-Drug Interaction Between Enlicitide Decanoate (MK-0616) and Alendronate in Healthy Adult Participants (MK-0616-027)

CompletedNCT06772792

Merck Sharp & Dohme LLCHealthy

Start: 2024-04-23End: 2024-06-21Updated: 2025-02-18

A Study of Enlicitide Decanoate (MK-0616), Warfarin, and Lisinopril in Healthy Adult Participants (MK-0616-026)

CompletedNCT06772779

Merck Sharp & Dohme LLCHealthy

Start: 2024-04-01End: 2024-06-04Updated: 2025-01-15

Phase 2

A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)

RecruitingNCT07058077

Merck Sharp & Dohme LLCHeterozygous Familial Hypercholesterolemia (HeFH)

Start: 2025-08-21End: 2037-01-23Target: 153Updated: 2026-09-14

Phase 3

A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-013) CORALreef Lipids

CompletedNCT05952856

Merck Sharp & Dohme LLCFamilial Hypercholesterolemia, Hypercholesterolemia

Start: 2023-08-10End: 2025-07-28Updated: 2026-08-06

A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017/CORALreef HeFH)

CompletedNCT05952869

Merck Sharp & Dohme LLCFamilial Hypercholesterolemia, Hypercholesterolemia

Start: 2023-08-08End: 2025-04-07Updated: 2026-02-24

Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Cardiovascular Outcomes Study (MK-0616-015) CORALreef Outcomes

Active, not recruitingNCT06008756

Merck Sharp & Dohme LLCArteriosclerosis, Hypercholesterolaemia

Start: 2023-10-09End: 2031-11-29Target: 14550Updated: 2026-04-23

Open-label Extension Study of Enlicitide Decanoate (MK-0616/Enlicitide Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-019) CORALreef Extension

Active, not recruitingNCT06492291

Merck Sharp & Dohme LLCHypercholesterolemia

Start: 2024-08-05End: 2028-10-13Target: 3000Updated: 2025-10-07

A Clinical Study of Enlicitide (MK-0616) in Adults With Hyperlipidemia in India (MK-0616-038)

Not yet recruitingNCT07821944

Merck Sharp & Dohme LLCHypercholesterolemia, Hyperlipidemia

Start: 2026-10-16End: 2027-11-26Target: 150Updated: 2026-09-16

Related Papers

Efficacy and Safety of Oral PCSK9 Inhibitor Enlicitide in Adults With Heterozygous Familial Hypercholesterolemia: A Randomized Clinical Trial.

2026-01-014 citations