About this data Sourced primarily from ClinicalTrials.gov — a listing isn't proof of safety or FDA approval.

Pipeline and clinical trial information here comes primarily from ClinicalTrials.gov. A listing on ClinicalTrials.gov means a study has been registered — not that a treatment is proven safe, effective, or FDA-approved. Investigational treatments may never be approved. Who can join a trial is decided only by that trial's own study team.

Not yet reported

MK-0616

Company: Merck Sharp & Dohme LLC
Mechanism: Mechanism not yet reported
Route: Route not yet reported
Recruiting trials: 2 recruiting

Efficacy results: Not yet reported

Find a Clinical Trial Near Me

2 recruiting studies currently listed on ClinicalTrials.gov.

Data source: ClinicalTrials.gov · trial data as of Oct 1, 2026

Trial details

Recruiting NCT NCT07058077

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

Not yet reported, Not yet reported Merck Sharp & Dohme LLC 153 participants Est. completion 2037-01-23 46 sites Stand-alone

Other conditions: Heterozygous Familial Hypercholesterolemia (HeFH)
View official trial listing →
Recruiting NCT NCT07614984

A Clinical Trial of MK-7262 and Enlicitide in Participants With High Lipoprotein(a) (MK-7262-004)

Not yet reported Merck Sharp & Dohme LLC 750 participants Est. completion 2027-10-12 70 sites Stand-alone

Other conditions: Lipoprotein(a)
View official trial listing →
Completed NCT NCT05070390

A Study of Enlicitide Chloride (MK-0616 Oral PCSK9 Inhibitor) in Participants With Moderate Renal Impairment (MK-0616-007)

Not yet reported Merck Sharp & Dohme LLC 18 participants Est. completion 2023-05-03 2 sites Stand-alone

Other conditions: Moderate Renal Impairment
View official trial listing →
Completed NCT NCT05261126

A Study of the Efficacy and Safety of Enclitide Chloride (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-008)

Not yet reported Merck Sharp & Dohme LLC 381 participants Est. completion 2022-11-28 63 sites Stand-alone

Other conditions: Hypercholesterolemia, Familial Hypercholesterolemia
View official trial listing →
Completed NCT NCT05934292

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

Not yet reported Merck Sharp & Dohme LLC 33 participants Est. completion 2024-01-19 5 sites Stand-alone

Other conditions: Hypercholesterolaemia
View official trial listing →
Completed NCT NCT05952856

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

Not yet reported Merck Sharp & Dohme LLC 2912 participants Est. completion 2025-07-28 168 sites Stand-alone

Other conditions: Hypercholesterolemia, Familial Hypercholesterolemia
View official trial listing →
Completed NCT NCT05952869

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

Not yet reported Merck Sharp & Dohme LLC 303 participants Est. completion 2025-04-07 59 sites Stand-alone

Other conditions: Hypercholesterolemia, Familial Hypercholesterolemia
View official trial listing →
Active, not recruiting NCT NCT06008756

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

Not yet reported Merck Sharp & Dohme LLC 14550 participants Est. completion 2031-11-29 669 sites Stand-alone

Other conditions: Arteriosclerosis, Hypercholesterolaemia
View official trial listing →
Completed NCT NCT06450366

A Study to Evaluate the Efficacy and Safety of Enlicitide (MK-0616, Oral PCSK9 Inhibitor) Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia (MK-0616-018/CORALreef AddOn)

Not yet reported Merck Sharp & Dohme LLC 301 participants Est. completion 2025-03-28 35 sites Stand-alone

Other conditions: Hypercholesterolemia
View official trial listing →
Active, not recruiting NCT NCT06492291

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

Not yet reported Merck Sharp & Dohme LLC 3000 participants Est. completion 2028-10-13 222 sites Stand-alone

Other conditions: Hypercholesterolemia
View official trial listing →
Completed NCT NCT06575959

A Clinical Study of Enlicitide Decanoate in People With Liver Function Problems (MK-0616-030)

Not yet reported Merck Sharp & Dohme LLC 20 participants Est. completion 2025-05-08 2 sites Stand-alone

Other conditions: Hepatic Insufficiency, Hepatic Impairment
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Completed NCT NCT06592339

A Study of MK-0616 in Healthy Adult Participants (MK-0616-009)

Not yet reported Merck Sharp & Dohme LLC 24 participants Est. completion 2022-12-29 1 site Stand-alone

Other conditions: Hypercholesterolemia
View official trial listing →
Completed NCT NCT06597760

A Clinical Study to Assess the Effect of Enlicitide on How the Body Processes Digoxin in Healthy Adult Participants (MK-0616-031)

Not yet reported Merck Sharp & Dohme LLC 24 participants Est. completion 2024-11-15 1 site Stand-alone

Other conditions: Healthy
View official trial listing →
Completed NCT NCT06609512

A Clinical Study of Enlicitide and the Effect of Food in Healthy Adult Participants (MK-0616-033)

Not yet reported Merck Sharp & Dohme LLC 20 participants Est. completion 2025-01-31 1 site Stand-alone

Other conditions: Healthy
View official trial listing →
Completed NCT NCT06625814

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

Not yet reported Merck Sharp & Dohme LLC 28 participants Est. completion 2024-09-11 1 site Stand-alone

Other conditions: Healthy
View official trial listing →
Completed NCT NCT06643377

A Clinical Study of Enlicitide in Participants With Severe Renal Impairment (MK-0616-032)

Not yet reported Merck Sharp & Dohme LLC 27 participants Est. completion 2025-06-25 5 sites Stand-alone

Other conditions: Healthy, Renal Impairment
View official trial listing →
Completed NCT NCT06655311

A Study of Enlicitide Chloride (MK-0616) in Healthy Participants and Participants Taking Statins (MK-0616-012)

Not yet reported Merck Sharp & Dohme LLC 56 participants Est. completion 2024-01-02 1 site Stand-alone

Other conditions: Healthy, Hypercholesterolemia
View official trial listing →
Completed NCT NCT06658626

A Study to Evaluate the Metabolism, Excretion, and Mass Balance of [¹⁴C]Enlicitide Chloride ([¹⁴C]MK-0616) in Healthy Participants (MK-0616-016)

Not yet reported Merck Sharp & Dohme LLC 8 participants Est. completion 2023-08-02 1 site Stand-alone

Other conditions: Healthy
View official trial listing →
Completed NCT NCT06658652

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

Not yet reported Merck Sharp & Dohme LLC 34 participants Est. completion 2023-12-26 1 site Stand-alone

Other conditions: Healthy
View official trial listing →
Completed NCT NCT06691906

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

Not yet reported Merck Sharp & Dohme LLC 40 participants Est. completion 2024-05-01 1 site Stand-alone

Other conditions: Healthy
View official trial listing →
Completed NCT NCT06699329

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

Not yet reported Merck Sharp & Dohme LLC 38 participants Est. completion 2024-05-24 1 site Added to GLP-1

Other conditions: Healthy
View official trial listing →
Completed NCT NCT06699355

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

Not yet reported Merck Sharp & Dohme LLC 18 participants Est. completion 2023-12-29 1 site Stand-alone

Other conditions: Healthy
View official trial listing →
Completed NCT NCT06719544

A Study of Lithium and Enlicitide in Healthy Adult Participants (MK-0616-034)

Not yet reported Merck Sharp & Dohme LLC 16 participants Est. completion 2025-02-06 1 site Stand-alone

Other conditions: Healthy
View official trial listing →
Completed NCT NCT06772779

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

Not yet reported Merck Sharp & Dohme LLC 36 participants Est. completion 2024-06-04 1 site Stand-alone

Other conditions: Healthy
View official trial listing →
Completed NCT NCT06772792

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

Not yet reported Merck Sharp & Dohme LLC 36 participants Est. completion 2024-06-21 1 site Stand-alone

Other conditions: Healthy
View official trial listing →
Completed NCT NCT06814106

A Single- and Multiple-Dose Study of Enlicitide Chloride (MK-0616) in Healthy Chinese Adult Participants (MK 0616-010)

Not yet reported Merck Sharp & Dohme LLC 37 participants Est. completion 2023-05-08 1 site Stand-alone

Other conditions: Healthy
View official trial listing →
Completed NCT NCT06880874

A Clinical Study to Evaluate Enlicitide (MK-0616) Formulations in Healthy Adult Participants (MK-0616-035)

Not yet reported Merck Sharp & Dohme LLC 40 participants Est. completion 2025-05-31 1 site Stand-alone

Other conditions: Healthy
View official trial listing →
Completed NCT NCT07044479

A Clinical Study of How Coffee and Tea Affect Enlicitide in Healthy Volunteers (MK-0616-040)

Not yet reported Merck Sharp & Dohme LLC 60 participants Est. completion 2025-08-28 1 site Stand-alone

Other conditions: Healthy
View official trial listing →
Active, not recruiting NCT NCT07216482

A Clinical Study of Enlicitide in Participants With High Cholesterol (MK-0616-037)

Not yet reported Merck Sharp & Dohme LLC 996 participants Est. completion 2026-11-05 87 sites Stand-alone

Other conditions: Hyperlipidemia
View official trial listing →
Active, not recruiting NCT NCT07300280

A Clinical Trial of Enlicitide and Rosuvastatin in Healthy Adults (MK-0616-039)

Not yet reported Merck Sharp & Dohme LLC 60 participants Est. completion 2026-10-21 1 site Stand-alone

Other conditions: Healthy
View official trial listing →
Completed NCT NCT07481708

A Clinical Study of the Effect of Enlicitide (MK-0616) Formulations in Healthy Participants (MK-0616-041)

Not yet reported Merck Sharp & Dohme LLC 30 participants Est. completion 2026-05-25 1 site Stand-alone

Other conditions: Healthy
View official trial listing →
Completed NCT NCT07619443

A Clinical Study of MK-7262 and Enlicitide in Healthy Participants (MK-7262-003)

Not yet reported Merck Sharp & Dohme LLC 30 participants Est. completion 2026-09-22 1 site Stand-alone

Other conditions: Healthy
View official trial listing →
Active, not recruiting NCT NCT07776665

A Clinical Trial of Enlicitide (MK-0616) Formulations in Healthy Participants (MK-0616-044)

Not yet reported Merck Sharp & Dohme LLC 30 participants Est. completion 2026-12-21 1 site Stand-alone

Other conditions: Healthy
View official trial listing →
Not yet recruiting NCT NCT07821944

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

Not yet reported Merck Sharp & Dohme LLC 150 participants Est. completion 2027-11-26 Stand-alone

Other conditions: Hyperlipidemia, Hypercholesterolemia
View official trial listing →

Efficacy history

Not yet reported.

Safety

Not yet reported.

Sources

ClinicalTrials.gov — NCT06592339

Also known as: MK-0616, Enlicitide Decanoate, enlicitide

Related On The Pen coverage

No related coverage yet.

This drug may be investigational and not yet approved for any use. Whether someone can join a clinical trial is determined only by that trial's own study team — On The Pen does not determine eligibility. Information here can change; always confirm current details on the official ClinicalTrials.gov listing or with the sponsor.