Recent Updates
Recently added Catalysts

Enlicitide Decanoate

Phase 3

Hypercholesterolemia | Small molecule | Metabolic |Merck & Company, Inc.|Last Updated: Jul 31, 2026

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials3
Total Enrollment6,215

FDA Designations

No designations recorded

Clinical trial landscape

Enlicitide Decanoate · 12 trials · 6 indications

Phase 3 4Phase 2 1Phase 1 7
NCT06492291Open-label Extension Study of Enlicitide Decanoate (MK-0616/Enlicitide Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-019) CORALreef ExtensionHypercholesterolemia
ACTIVE NOT_RECRUITING3,000 Analytics
NCT06008756Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Cardiovascular Outcomes Study (MK-0616-015) CORALreef OutcomesArteriosclerosis
ACTIVE NOT_RECRUITING14,550 Analytics
NCT05952856A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-013) CORALreef LipidsHypercholesterolemia
COMPLETED2,912 Analytics
NCT05952869A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017/CORALreef HeFH)Hypercholesterolemia
COMPLETED303 Analytics
PHASE3ACTIVE NOT_RECRUITING
Open-label Extension Study of Enlicitide Decanoate (MK-0616/Enlicitide Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-019) CORALreef Extension
HypercholesterolemiaUnlock trial analytics
PHASE3ACTIVE NOT_RECRUITING
Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Cardiovascular Outcomes Study (MK-0616-015) CORALreef Outcomes
ArteriosclerosisUnlock trial analytics
PHASE3COMPLETED
A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-013) CORALreef Lipids
HypercholesterolemiaUnlock trial analytics
PHASE3COMPLETED
A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017/CORALreef HeFH)
HypercholesterolemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with one or more adverse events (AEs)
Up to approximately 3 years

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Number of participants who discontinue study drug due to an AE
Up to approximately 3 years

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Blinded Period: Time to First Occurrence of Coronary Heart Disease (CHD) Death-Based Major Adverse Cardiovascular Events (MACE)-Plus
From date of randomization until the date of first occurrence of CHD death-based MACE-plus, assessed up to approximately 6 years

Time to the first occurrence of CHD death-based MACE-plus, which is defined as any of the following: coronary heart disease death, myocardial infarction (MI), ischemic stroke (fatal and nonfatal), acute limb ischemia or major amputation, or urgent arterial revascularization (coronary, cerebrovascular, or peripheral).

Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24
Baseline and Week 24

Blood samples will be collected at baseline and at Week 24 to assess mean percent change in LDL-C.

Number of Participants With Adverse Events (AEs)
Up to 64 weeks (8 weeks postdose)

An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Number of Participants Who Discontinued Study Drug Due to an AE
Up to 56 weeks

An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Part A: Maximum Plasma Concentration (Cmax) of Enlicitide
At designated timepoints (up to 24 hours postdose on day 14)

Blood samples will be collected to determine the Cmax of enlicitide.

Part A: Area Under the Concentration-Time Curve from 0 to 24 Hours (AUC0-24) of Enlicitide
At designated timepoints (up to 24 hours postdose on day 14)

Blood samples will be collected to determine the AUC0-24 of enlicitide.

Part B: Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)
Baseline and Week 24

Blood samples will be collected to determine the percent change from baseline in LDL-C.

Number of Participants Who Experience an Adverse Event (AE)
Up to approximately 188 weeks

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Number of Participants Who Discontinue Study Treatment Due to an AE
Up to approximately 180 weeks

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Area under the Concentration-Time Curve from Time 0 to 48 hours (AUC0-48hrs) of Levothyroxine (total T4)
At designated timepoints (up to approximately 48 hours postdose)

Blood samples will be collected to determine the AUC0-48hr of Levothyroxine (T4).

Maximum Plasma Concentration (Cmax) of Levothyroxine (total T4)
At designated timepoints (up to approximately 48 hours postdose)

Blood samples will be collected to determine the Cmax of Levothyroxine (T4).

Time to Maximum Plasma Concentration (Tmax) of Levothyroxine (total T4)
At designated timepoints (up to approximately 48 hours postdose)

Blood samples will be collected to determine the Tmax of Levothyroxine (T4).

Area under the Concentration-Time Curve from Time 0 to 48 hours (AUC0-48hrs) of Triiodothyronine (total T3)
At designated timepoints (up to approximately 48 hours postdose)

Blood samples will be collected to determine the AUC0-48hr of triiodothyronine (T3).

Maximum Plasma Concentration (Cmax) of Triiodothyronine (total T3)
At designated timepoints (up to approximately 48 hours postdose)

Blood samples will be collected to determine the Cmax of triiodothyronine (T3).

Time to Maximum Plasma Concentration (Tmax) of Triiodothyronine (total T3)
At designated timepoints (up to approximately 48 hours postdose)

Blood samples will be collected to determine the Tmax of triiodothyronine (T3).

Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Warfarin
At designated timepoints (up to approximately 2 weeks postdose)

Blood samples will be collected to determine the AUC0-Inf of warfarin.

Area Under the Concentration-Time Curve from Time 0 to Last Measurable Concentration (AUC0-Last) of Warfarin
At designated timepoints (up to approximately 2 weeks postdose)

Blood samples will be collected to determine the AUC0-Last of warfarin.

Maximum Plasma Concentration (Cmax) of Warfarin
At designated timepoints (up to approximately 2 weeks postdose)

Blood samples will be collected to determine the Cmax of warfarin.

Time to Maximum Plasma Concentration (Tmax) of Warfarin
At designated timepoints (up to approximately 2 weeks postdose)

Blood samples will be collected to determine the Tmax of warfarin.

Apparent Terminal Half-life (t½) of Warfarin
At designated timepoints (up to approximately 2 weeks postdose)

Blood samples will be collected to determine the t½ of warfarin.

Apparent Clearance (CL/F) of Warfarin
At designated timepoints (up to approximately 2 weeks postdose)

Blood samples will be collected to determine the CL/F of warfarin.

Apparent Volume of Distribution During Terminal Phase (Vz/F) of Warfarin
At designated timepoints (up to approximately 2 weeks postdose)

Blood samples will be collected to determine the Vz/F of warfarin.

Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Lisinopril
At designated timepoints (up to approximately 3 days postdose)

Blood samples will be collected to determine the AUC0-Inf of lisinopril.

Area Under the Concentration-Time Curve from Time 0 to Last Measurable Concentration (AUC0-Last) of Lisinopril
At designated timepoints (up to approximately 3 days postdose)

Blood samples will be collected to determine the AUC0-Last of lisinopril.

Maximum Plasma Concentration (Cmax) of Lisinopril
At designated timepoints (up to approximately 3 days postdose)

Blood samples will be collected to determine the Cmax of lisinopril.

Time to Maximum Plasma Concentration (Tmax) of Lisinopril
At designated timepoints (up to approximately 3 days postdose)

Blood samples will be collected to determine the Tmax of lisinopril.

Apparent Terminal Half-life (t½) of Lisinopril
At designated timepoints (up to approximately 3 days postdose)

Blood samples will be collected to determine the t½ of lisinopril.

Apparent Clearance (CL/F) of Lisinopril
At designated timepoints (up to approximately 3 days postdose)

Blood samples will be collected to determine the CL/F of lisinopril.

Apparent Volume of Distribution During Terminal Phase (Vz/F) of Lisinopril
At designated timepoints (up to approximately 3 days postdose)

Blood samples will be collected to determine the Vz/F of lisinopril.

Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of enlicitide decanoate
Predose and at designated timepoints (up to 24 hours postdose)

Blood samples will be collected to determine the AUC0-24 of enlicitide decanoate.

Area Under the Concentration-Time Curve from 0 to Time of Last Quantifiable Sample (AUC0-last) of enlicitide decanoate
Predose and at designated timepoints (up to 168 hours postdose)

Blood samples will be collected to determine the AUC0-last of enlicitide decanoate.

Area Under the Concentration-Time Curve from 0 to Infinity (AUC0-inf) of enlicitide decanoate
Predose and at designated timepoints (up to 168 hours postdose)

Blood samples will be collected to determine the AUC0-inf of enlicitide decanoate.

Maximum Plasma Concentration (Cmax) of enlicitide decanoate
Predose and at designated timepoints (up to 168 hours postdose)

Blood samples will be collected to determine the Cmax of enlicitide decanoate.

Time to Maximum Plasma Concentration (Tmax) of enlicitide decanoate
Predose and at designated timepoints (up to 168 hours postdose)

Blood samples will be collected to determine the Tmax of enlicitide decanoate.

Apparent Terminal Half-Life (t1/2) of enlicitide decanoate
Predose and at designated timepoints (up to 168 hours postdose)

Blood samples will be collected to determine the t1/2 of enlicitide decanoate.

Apparent Clearance (CL/F) of enlicitide decanoate
Predose and at designated timepoints (up to 168 hours postdose)

Blood samples will be collected to determine the CL/F of enlicitide decanoate.

Apparent Volume of Distribution During Terminal Phase (Vz/F) of enlicitide decanoate
Predose and at designated timepoints (up to 168 hours postdose)

Blood samples will be collected to determine the Vz/F of enlicitide decanoate.

Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of Enlicitide Decanoate
At designated timepoints (up to 24 hours postdose)

Blood samples will be collected to determine the AUC0-24hrs of enlicitide decanoate.

Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of Semaglutide
At designated timepoints (up to 24 hours postdose)

Blood samples will be collected to determine the AUC0-24hrs of semaglutide.

Maximum Plasma Concentration (Cmax) of Semaglutide
At designated timepoints (up to approximately 2 weeks postdose)

Blood samples will be collected to determine the Cmax of semaglutide.

Time to Maximum Plasma Concentration (Tmax) of Semaglutide
At designated timepoints (up to approximately 2 weeks postdose)

Blood samples will be collected to determine the Tmax of semaglutide.

Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Atorvastatin and its Metabolites
At designated timepoints (up to approximately 8 days)

Blood samples will be collected to determine the AUC0-Inf of atorvastatin and its metabolites.

Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Atorvastatin and its Metabolites
At designated timepoints (up to approximately 8 days)

Blood samples will be collected to determine the AUC0-Last of atorvastatin and its metabolites.

Maximum Plasma Concentration (Cmax) of Atorvastatin and its Metabolites
At designated timepoints (up to approximately 8 days)

Blood samples will be collected to determine the Cmax of atorvastatin and its metabolites.

Time to Maximum Plasma Concentration (Tmax) of Atorvastatin and its Metabolites
At designated timepoints (up to approximately 8 days)

Blood samples will be collected to determine the Tmax of atorvastatin and its metabolites.

Apparent Terminal Half-Life (t1/2) of Atorvastatin and its Metabolites
At designated timepoints (up to approximately 8 days)

Blood samples will be collected to determine the t1/2 of atorvastatin and its metabolites.

Apparent Clearance (CL/F) of Atorvastatin
At designated timepoints (up to approximately 8 days)

Blood samples will be collected to determine the CL/F of atorvastatin.

Apparent Volume of Distribution (Vz/F) of Atorvastatin
At designated timepoints (up to approximately 8 days)

Blood samples will be collected to determine the Vz/F of atorvastatin.

Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Enlicitide Decanoate
At designated timepoints (up to approximately 8 days)

Blood samples will be collected to determine the AUC0-Inf of enlicitide decanoate.

Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Enlicitide Decanoate
At designated timepoints (up to approximately 8 days)

Blood samples will be collected to determine the AUC0-Last of enlicitide decanoate.

Apparent Volume of Distribution (Vz/F) of Enlicitide Decanoate
At designated timepoints (up to approximately 8 days)

Blood samples will be collected to determine the Vz/F of enlicitide decanoate.

Lag Time (tlag) of Enlicitide Decanoate in Plasma
Pre-dose and at designated time points up to 1 week postdose

Tlag is the time from dosing to the first appearance in plasma. Blood samples will be collected to determine the tlag of enlicitide decanoate.

AUC From Time 0 to Last Measurable Concentration (AUClast) of Enlicitide Decanoate
Predose and 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168, and 240 hours postdose

AUClast was defined as the area under the concentration-time curve of enlicitide decanoate from time zero to last measurable concentration. Blood for plasma samples was collected at pre-specified timepoints to determine the AUClast of enlicitide decanoate in Panel A, B, C, and D participants. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C ESRD - enlicitide decanoate pre-hemodialysis and Panel C ESRD - enlicitide decanoate post-hemodialysis to report AUClast. Per protocol, mean AUClast was reported.

Secondary Endpoints

Mean percent change from baseline of the parent study in LDL-C at Week 8 of this extension study
Baseline of the parent study and Week 8 of this extension study
Mean percent change from baseline of the parent study in non-high-density lipoprotein cholesterol (non-HDL-C) at Week 8 of this Extension Study
Baseline of the parent study and Week 8 of this extension study
Mean percent change from baseline of the parent study in apolipoprotein B (ApoB) at Week 8 of this extension study
Baseline of the parent study and Week 8 of this extension study
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Enlicitide DecanoateEXPERIMENTALParticipants will receive 20 mg of enlicitide decanoate orally once daily (QD)
Blinded Portion: Enlicitide DecanoateEXPERIMENTALParticipants receive enlicitide decanoate 20 mg once daily.
Blinded Portion: PlaceboPLACEBO_COMPARATORParticipants receive placebo once daily.
Open-Label Extension: Enlicitide DecanoateEXPERIMENTALParticipants who complete the blinded portion may enroll in this open-label extension arm. Participants in the extension arm receive enlicitide decanoate once daily up to 2 years.
PlaceboPLACEBO_COMPARATORParticipants will receive enlicitide decanoate-matching placebo orally QD for up to 52 weeks.
Part A: Enlicitide DecanoateEXPERIMENTALParticipants receive enlicitide decanoate orally once daily (QD) at a dosage determined by age for up to 2 weeks.
Part B: Enlicitide DecanoateEXPERIMENTALParticipants receive enlicitide decanoate QD at a dosage determined by age for up to 24 weeks.
Part B: PlaceboPLACEBO_COMPARATORParticipants receive placebo orally QD for up to 24 weeks.
LevothyroxineEXPERIMENTALParticipants will receive a single oral dose of levothyroxine.
Levothyroxine Plus Enlicitide DecanoateEXPERIMENTALParticipants will receive a single oral dose of levothyroxine and a single oral dose of enlicitide decanoate at the same time.
Warfarin Plus Enlicitide DecanoateEXPERIMENTALParticipants receive oral warfarin and oral enlicitide decanoate.
Lisinopril Plus Enlicitide DecanoateEXPERIMENTALParticipants receive oral lisinopril and oral enlicitide decanoate.
Enlicitide Decanoate Treatment AEXPERIMENTALParticipants will receive a single dose of enlicitide decanoate formulation 1 on Day 1 on an empty stomach.
Enlicitide Decanoate Treatment BEXPERIMENTALParticipants will receive a single dose of enlicitide decanoate formulation 2 on Day 1 on an empty stomach.
Enlicitide Decanoate and SemaglutideEXPERIMENTALPeriod 1: Participants receive an oral dose of enlicitide decanoate every day for 1 week. Period 2: Participants receive an oral dose of semaglutide every day for 6 weeks. Period 3: Participants receive an oral dose of both enlicitide decanoate and semaglutide every day for 1 week.
AtorvastatinEXPERIMENTALParticipants receive a single oral dose of atorvastatin (Treatment A) on Day 1.
Enlicitide Decanoate + AtorvastatinEXPERIMENTALParticipants receive a single oral dose of enlicitide decanoate plus a single oral dose of atorvastatin (Treatment B) on Day 1.
Enlicitide Decanoate Food EffectEXPERIMENTALParticipants will be administered enlicitide decanoate on Day 1 with or without food.
Enlicitide Decanoate Water EffectEXPERIMENTALParticipants will be administered enlicitide decanoate on Day 1 with high, medium, and low volumes of water.
Panel A: Moderate Renal Impairment (RI)EXPERIMENTALParticipants receive Enlicitide Decanoate 20 mg tablet single dose orally on Day 1
Panel B: Severe RIEXPERIMENTALParticipants receive Enlicitide Decanoate 20 mg tablet single dose orally on Day 1
Panel C: End-Stage Renal Disease (ESRD) on Hemodialysis (HD)EXPERIMENTALParticipants receive Enlicitide Decanoate 20 mg tablet orally on Day 1 and Day 16.
Panel D: Healthy ControlsEXPERIMENTALParticipants receive Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.

Interventions

NameTypeDescription
Enlicitide DecanoateDRUGOral tablet
PlaceboDRUGPlacebo tablet matched to enlicitide decanoate taken by mouth.
LevothyroxineDRUGsingle oral dose
WarfarinDRUGsingle oral dose
LisinoprilDRUGsingle oral dose
SemaglutideDRUGmultiple doses, oral tablet
AtorvastatinDRUGOral administration
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites222

Inclusion Criteria: * Has completed an enlicitide decanoate (also known as enlictide and MK-0616) parent study \[MK-0616-013 (NCT05952856), MK-0616-017 (NCT05952869), and MK-0616-018 (NCT06450366)\] per protocol (including the final assessments/procedures of their parent study) * Had an overall stu...

Countries:United StatesArgentinaAustraliaBrazilCanadaChileChinaColombiaCzechiaFinlandFranceGermanyHong KongHungaryIsraelItalyJapanMexicoNetherlandsNew ZealandNorwaySingaporeSouth AfricaSouth KoreaSpainTaiwanTurkey (Türkiye)United KingdomDenmarkPeruPolandPuerto RicoBelgium
Unlock Eligibility Criteria

Recent Changes (Last 90 Days)

LOWJul 31, 2026NCT07058077lastUpdatePostDate: changed
LOWJul 31, 2026NCT07058077lastUpdatePostDate: changed
LOWJul 24, 2026NCT07058077lastUpdatePostDate: changed
LOWJul 24, 2026NCT07058077lastUpdatePostDate: changed
LOWJul 10, 2026NCT07058077lastUpdatePostDate: changed
LOWJul 10, 2026NCT07058077lastUpdatePostDate: changed
LOWJul 2, 2026NCT07058077lastUpdatePostDate: changed
LOWJul 2, 2026NCT07058077lastUpdatePostDate: changed
LOWJun 25, 2026NCT07058077lastUpdatePostDate: changed
LOWJun 25, 2026NCT07058077lastUpdatePostDate: changed
LOWJun 25, 2026NCT07058077lastUpdatePostDate: changed
LOWMay 29, 2026NCT07058077lastUpdatePostDate: changed
LOWMay 29, 2026NCT07058077lastUpdatePostDate: changed
LOWMay 29, 2026NCT07058077lastUpdatePostDate: changed
LOWMay 26, 2026NCT07058077primaryCompletionDate: changed
MEDIUMMay 26, 2026NCT06008756primaryCompletionDate: changed
LOWMay 26, 2026NCT06492291primaryCompletionDate: changed
LOWMay 24, 2026NCT07058077studyFirstPostDate: changed
LOWMay 24, 2026NCT06008756studyFirstPostDate: changed
LOWMay 24, 2026NCT06492291studyFirstPostDate: changed

Frequently asked questions about Enlicitide Decanoate

What is Enlicitide Decanoate used for?

Enlicitide Decanoate is an investigational small molecule being developed for cardiovascular conditions including arteriosclerosis, heterozygous familial hypercholesterolemia (HeFH), and hypercholesterolemia. It is currently in Phase 3 clinical development by Merck & Company, Inc. (MRK). The drug is being studied to address cholesterol-related disorders.

What does Enlicitide Decanoate target?

Enlicitide Decanoate is a small molecule with a peptide-based target class, classified as a -tide (peptide) therapeutic. It is being developed to target pathways involved in cholesterol metabolism for the treatment of hypercholesterolemia and related cardiovascular conditions. The specific molecular target has not been disclosed in available information.

Who makes Enlicitide Decanoate?

Enlicitide Decanoate is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. Merck is conducting clinical trials to evaluate the drug for cardiovascular indications including hypercholesterolemia and heterozygous familial hypercholesterolemia.

What phase is Enlicitide Decanoate in?

Enlicitide Decanoate is currently in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 program includes studies in patients with hypercholesterolemia and related conditions, building on earlier Phase 1 trials in healthy volunteers.

What clinical trials is Enlicitide Decanoate in?

Enlicitide Decanoate has been studied in several clinical trials. Phase 1 trials include NCT06625814, NCT06691906, NCT06699329, and NCT06699355, all completed in healthy adults in the United States. These studies evaluated the drug alone and in combination with levothyroxine, semaglutide, and atorvastatin. The drug is now in Phase 3 development.

Is Enlicitide Decanoate the same as MK-0616?

Yes, Enlicitide Decanoate is also known as MK-0616. Clinical trial records reference both names, with studies titled using MK-0616 as the identifier. This includes Phase 1 trials in healthy participants and the ongoing Phase 3 program for cardiovascular indications.