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Enlicitide Decanoate

Phase 3

Arteriosclerosis | Small molecule | Metabolic |Merck & Company, Inc.|Last Updated: Apr 23, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment14,550
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06008756Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Cardiovascular Outcomes Study (MK-0616-015) CORALreef OutcomesPHASE3 ACTIVE NOT_RECRUITING 14,550 — — Oct 9, 2023Nov 29, 2031Apr 23, 2026669 United States, Argentina +27
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Study Endpoints
Primary Endpoints
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).

Secondary Endpoints
Blinded Period: Time to First Occurrence of 3-point MACE
From date of randomization until the date of first occurrence of 3-point MACE, assessed up to approximately 6 years
Blinded Period: Time to First Occurrence of Cardiovascular (CV) Death-Based MACE Plus
From date of randomization until the date of first occurrence of CV death-based MACE plus, assessed up to approximately 6 years
Blinded Period: Time to First Occurrence of CHD Death or MI
From date of randomization until the date of first occurrence of CHD death or MI, assessed up to approximately 6 years
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
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.
Interventions
NameTypeDescription
Enlicitide DecanoateDRUGEnlicitide Decanoate 20 mg tablet taken by mouth.
PlaceboDRUGPlacebo tablet matched to enlicitide decanoate taken by mouth.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites669

Inclusion Criteria: * Meets one of the following: 1. Age ≥18 years with a history of a major atherosclerotic cardiovascular disease (ASCVD) event defined as at least 1 of the following: ≥30 days post MI (presumed Type 1 due to plaque rupture or erosion); ≥30 days post ischemic stroke (presumed d...

Countries:United StatesArgentinaAustraliaBrazilCanadaChileChinaColombiaDenmarkFranceGermanyHong KongHungaryIsraelItalyJapanMexicoNetherlandsNew ZealandNorwayPeruPolandPuerto RicoSouth AfricaSouth KoreaSpainTaiwanTurkey (Türkiye)United Kingdom
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT06008756primaryCompletionDate: changed
LOWMay 24, 2026NCT06008756studyFirstPostDate: changed