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Active, not recruitingNCT06008756Updated Apr 23, 2026

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

A Phase 3 interventional study of Enlicitide Decanoate and Placebo in Arteriosclerosis and Hypercholesterolaemia, sponsored by Merck Sharp & Dohme LLC. Active, not recruiting at 669 sites in 29 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-23.

Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
14,550
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a phase 3, randomized, placebo-controlled study of the efficacy and safety of enlicitide decanoate, an oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, in participants with high cardiovascular risk. The primary objective is to evaluate the efficacy of enlicitide decanoate compared with placebo in increasing the time to the first occurrence of major adverse cardiovascular events (MACE) including coronary heart disease (CHD) death, ischemic stroke, myocardial infarction (MI), acute limb ischemia or major amputation, or urgent arterial revascularization.

02

Conditions studied

  • Arteriosclerosis
  • Hypercholesterolaemia
03

In context

Arteriosclerosis

157 studies on the registry are indexed under Arteriosclerosis; 18 are open to participants now.

This study's planned enrollment of 14,550 is above the median of 109 across 104 interventional studies indexed under Arteriosclerosis.

Browse Arteriosclerosis studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,166 studies on the registry; 132 are open to participants now.

Of its 501 completed or terminated interventional studies of FDA-regulated products, 370 (74%) have results posted.

Browse Merck Sharp & Dohme LLC studies →All Merck & Co., Inc studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 due to atherosclerosis); or ≥30 days post successful peripheral (carotid or lower extremity) arterial revascularization (surgical or endovascular) or major (ankle or above) amputation due to atherosclerosis; or
    2. High risk for first major ASCVD event defined as at least 1 of the following: Age ≥50 years with evidence of coronary artery disease; Age ≥50 years with evidence of atherosclerotic cerebrovascular disease; Age ≥50 years with evidence of peripheral arterial disease; or Age ≥60 years with diabetes mellitus and at least one of the following: microvascular disease or urine albumin-creatinine ratio ≥30 mg/mmol within 6 months before Visit 1, daily insulin use, or diabetes for ≥10 years

  • Has fasted lipid values (evaluated by the Central Laboratory) at Visit 1 (Screening) as follows:

    1. History of major ASCVD Event: LDL-C ≥70 mg/dL (1.81 mmol/L) OR non-HDL-C ≥100 mg/dL (2.59 mmol/L)
    2. High risk for first major ASCVD Event: LDL-C ≥90 mg/dL (2.33 mmol/L) OR non-HDL-C ≥120 mg/dL (3.11 mmol/L)
  • Is treated with moderate- or high-intensity statin (± nonstatin lipid-lowering therapy [LLT]) at Visit 1
  • Is on a stable dose of all background LLTs (including statin and nonstatin agents) for at least 30 days before Visit 1 (Screening) with no medication or dose changes planned during the participation in the study

Exclusion criteria

Exclusion Criteria:

  • Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria, compound heterozygous FH, or double heterozygous FH
  • Has Class IV heart failure, last known ≤25% by any imaging method, or had a Heart Failure hospitalization within 3 months before Visit 1 (Screening)
  • Has recurrent ventricular tachycardia within 3 months prior to randomization
  • Has a planned arterial revascularization procedure
  • Is undergoing or previously underwent an LDL-C apheresis program within 3 months before Visit 1 (Screening) or plans to initiate an LDL-C apheresis program
  • Was previously treated/is being treated with certain other cholesterol lowering medications, including protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors without adequate .
  • Has a fasting triglyceride value ≥400 mg/dL (≥4.52 mmol/L) at Visit 1 (Screening)
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
14,550 participants (estimated)

Study arms

  • Experimental
    Blinded Portion: Enlicitide Decanoate

    Participants receive enlicitide decanoate 20 mg once daily.

    Drug: Enlicitide Decanoate

  • Placebo comparator
    Blinded Portion: Placebo

    Participants receive placebo once daily.

    Drug: Placebo

  • Experimental
    Open-Label Extension: Enlicitide Decanoate

    Participants 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.

    Drug: Enlicitide Decanoate

Interventions

  • DrugEnlicitide Decanoate

    Enlicitide Decanoate 20 mg tablet taken by mouth.

    Also known as: MK-0616

  • DrugPlacebo

    Placebo tablet matched to enlicitide decanoate taken by mouth.

06

What researchers measure

Primary outcomes

  1. Blinded Period: Time to First Occurrence of Coronary Heart Disease (CHD) Death-Based Major Adverse Cardiovascular Events (MACE)-Plus

    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).

    Time frame: From date of randomization until the date of first occurrence of CHD death-based MACE-plus, assessed up to approximately 6 years

Secondary outcomes

  1. Blinded Period: Time to First Occurrence of 3-point MACE

    Time to the first occurrence of 3-point MACE (defined as cardiovascular death, MI, or ischemic stroke).

    Time frame: From date of randomization until the date of first occurrence of 3-point MACE, assessed up to approximately 6 years

  2. Blinded Period: Time to First Occurrence of Cardiovascular (CV) Death-Based MACE Plus

    Time to the first occurrence of CV death-based MACE plus, defined as any of the following: cardiovascular death, MI, ischemic stroke, acute limb ischemia or major amputation, or urgent arterial revascularization (coronary, cerebrovascular, or peripheral).

    Time frame: From date of randomization until the date of first occurrence of CV death-based MACE plus, assessed up to approximately 6 years

  3. Blinded Period: Time to First Occurrence of CHD Death or MI

    Time to the first occurrence of CHD death or MI.

    Time frame: From date of randomization until the date of first occurrence of CHD death or MI, assessed up to approximately 6 years

  4. Blinded Period: Time to CV Death

    Time to cardiovascular death.

    Time frame: From date of randomization until the date of CV death, assessed up to approximately 6 years

  5. Blinded Period: Time to All-Cause Death

    Time to all-cause death.

    Time frame: From date of randomization until the date of death, assessed up to approximately 6 years

  6. Blinded Period: Time to CHD Death

    Time to CHD death.

    Time frame: From date of randomization until the date of CHD death, assessed up to approximately 6 years

  7. Blinded Period: Time to First Event of MI

    Time to the first occurrence of MI.

    Time frame: From date of randomization until the date of MI, assessed up to approximately 6 years

  8. Blinded Period: Time to First Event of Ischemic Stroke

    Time to the first occurrence of ischemic stroke.

    Time frame: From date of randomization until the date of first occurrence of ischemic stroke, assessed up to approximately 6 years

  9. Blinded Period: Time to First Event of Acute Limb Ischemia or Major Amputation

    Time to the first occurrence of acute limb ischemia or major amputation.

    Time frame: From date of randomization until the date of first occurrence of acute limb ischemia or major amputation, assessed up to approximately 6 years

  10. Blinded Period: Time to First Event of Urgent Arterial Revascularization

    Time to the first occurrence of urgent arterial revascularization (coronary, cerebrovascular, or peripheral).

    Time frame: From date of randomization until the date of urgent arterial revascularization, assessed up to approximately 6 years

  11. Blinded Period: Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)

    The percent change from baseline in LDL-C.

    Time frame: Baseline and Week 52

  12. Blinded Period: Percent Change from Baseline in Apolipoprotein B

    The percent change from baseline in apolipoprotein B.

    Time frame: Baseline and Week 52

  13. Blinded Period: Percent Change from Baseline in Non-High-Density Lipoprotein Cholesterol (non-HDL-C) cholesterol

    The percent change from baseline in Non-HDL-C.

    Time frame: Baseline and Week 52

  14. Blinded Period: Percent Change from Baseline in Lipoprotein (a)

    The percent change from baseline in lipoprotein (a).

    Time frame: Baseline and Week 52

  15. Blinded Period: Number of Participants with an Adverse Event (AE)

    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. The number of participants with AE(s) in each arm will be reported.

    Time frame: Up to approximately 6 years

  16. Blinded Period: Number of Participants Discontinuing from Study Therapy Due to AE

    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. The number of participants discontinuing due to AE(s) in each arm will be reported.

    Time frame: Up to approximately 6 years

  17. Open-Label Extension (OLE): Time to First Occurrence of CHD Death-Based MACE Plus

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

    Time frame: From date of randomization until the date of first occurrence of CHD death-based MACE plus, assessed up to approximately 8 years

07

Study locations

669 sites

Showing the first 100 of 669 sites across 29 countries. Choose a country and city above to see the rest.

08

References and documents

Individual participant data

Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Data sharing details ↗ · externaldatasharing-msd.com

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2023 (actual). Primary completion is estimated for Nov 2029, 73 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 17, 2023
First posted
Aug 24, 2023
StartActual
Oct 9, 2023
Primary completionEst.
Nov 29, 2029
CompletionEst.
Nov 29, 2031
Last update
Apr 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06008756
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Aug 24, 2023
Start date
Oct 9, 2023
Primary completion
Nov 29, 2029 (estimated)
Completion
Nov 29, 2031 (estimated)
Last update
Apr 23, 2026

Study contacts

Medical Director
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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