Enlicitide

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

HypercholesterolemiaHyperlipidemiaFamilial HypercholesterolemiaLipoprotein(a)

130 competitors in Hypercholesterolemia

#DrugCompanyPhaseTrials

1

Lescol

Novartis

Phase 3

12

Avapro

Sanofi

Phase 3

13

Micardis

Boehringer Ingelheim

Phase 3

14

Comparator: Statins

Merck & Co.

Phase 3

35

Evacetrapib

Eli Lilly

Phase 3

26

Statin

Bristol-Myers Squibb

Phase 3

27

Kynamro

KKastle Therapeutics, LLC

Phase 3

18

Anacetrapib

Merck & Co.

Phase 3

19

Lapaquistat Acetate

Takeda

Phase 3

910

Enlicitide

Merck & Co.

Phase 3

3Show 27 more competitors

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Clinical

Trials by Indication[1]

Adult8 trials

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

Completed·Merck & Co.·Phase 1·NCT06597760·24 enrolled

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

Completed·Merck & Co.·Phase 1·NCT06609512·20 enrolled

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

Completed·Merck & Co.·Phase 1·NCT06691906·40 enrolled

Show 5 more trials

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

Completed·Merck & Co.·Phase 1·NCT06625814·28 enrolled

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

Completed·Merck & Co.·Phase 1·NCT06772779·36 enrolled

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

Completed·Merck & Co.·Phase 1·NCT06814106·37 enrolled

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

Completed·Merck & Co.·Phase 1·NCT06880874·40 enrolled

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

Completed·Merck & Co.·Phase 1·NCT06719544·16 enrolled

Hypercholesterolemia3 trials

A Study to Evaluate the Efficacy and Safety of Enlicitide Decanoate (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

Completed·Merck & Co.·Phase 3·NCT06450366·301 enrolled

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·Merck & Co.·Phase 3·NCT06492291·3,000 enrolled

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

Completed·Merck & Co.·Phase 3·NCT05952856·2,912 enrolled

Renal Impairment3 trials

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

Completed·Merck & Co.·Phase 1·NCT05070390·18 enrolled

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

Completed·Merck & Co.·Phase 1·NCT05934292·33 enrolled

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

Completed·Merck & Co.·Phase 1·NCT06643377·27 enrolled

PCSK9 Inhibitor1 trial

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

Active, not recruiting·Merck & Co.·Phase 3·NCT06008756·14,550 enrolled

Metabolism1 trial

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

Completed·Merck & Co.·Phase 1·NCT06658626·8 enrolled

13 more indications

Familial Hypercholesterolemia1 trial

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

Completed·Merck & Co.·Phase 3·NCT05952869·303 enrolled

Clinical Trial1 trial

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

Active, not recruiting·Merck & Co.·Phase 1·NCT07300280·60 enrolled

Function1 trial

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

Completed·Merck & Co.·Phase 1·NCT06575959·20 enrolled

Statins1 trial

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

Completed·Merck & Co.·Phase 1·NCT06655311·56 enrolled

Atorvastatin1 trial

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

Completed·Merck & Co.·Phase 1·NCT06699355·18 enrolled

Semaglutide1 trial

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

Completed·Merck & Co.·Phase 1·NCT06699329·38 enrolled

Volume1 trial

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

Completed·Merck & Co.·Phase 1·NCT06658652·34 enrolled

Interaction1 trial

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

Completed·Merck & Co.·Phase 1·NCT06772792·36 enrolled

ART1 trial

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

Not yet recruiting·Merck & Co.·Phase 1·NCT07481708·30 enrolled

Heterozygous Familial Hypercholesterolemia (HeFH)1 trial

An Operationally Seamless Phase 2/3 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Enlicitide Decanoate in Pediatric Participants With Heterozygous Familial Hypercholesterolemia

Recruiting·Merck & Co.·Preclinical·NCT07058077·153 enrolled

Lipoprotein(a)1 trial

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-7262 as Monotherapy and When Coadministered With Enlicitide Decanoate in Adults With Elevated Lipoprotein(a)

Recruiting·Merck & Co.·Phase 2·NCT07614984·750 enrolled

Hyperlipidemia1 trial

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Enlicitide Decanoate Coadministered With Rosuvastatin in Adults With Hyperlipidemia

Active, not recruiting·Merck & Co.·Phase 3·NCT07216482·975 enrolled

Unspecified2 trials

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

Completed·Merck & Co.·Phase 1·NCT07044479·60 enrolled

A Clinical Drug-Drug Interaction Study to Evaluate the Mutual Pharmacokinetic Effects of MK-7262 and Enlicitide in Healthy Participants

Recruiting·Merck & Co.·Phase 1·NCT07619443·30 enrolled

Details

Drug Info

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