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Trial · Interventional

Active, not recruitingPhase 3Registry data

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

NCTNCT06008756 (opens ClinicalTrials.gov in a new tab)Other id0616-015Other idjRCT2071230064Other id2022-502781-24-00Other idU1111-1285-4245
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Active, not recruiting
Phase
Phase 3
Enrollment
14,550 participants (estimated)
Sponsor
Merck Sharp & Dohme LLC · Industry
Design
Randomized · Triple masking
Countries
29 countries

United States, Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Peru, Poland, Puerto Rico, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom

Start
9 Oct 2023
Primary completion
29 Nov 2029 (estimated)
Completion
29 Nov 2031 (estimated)
First posted
24 Aug 2023
Last update posted
23 Apr 2026
Conditions
Arteriosclerosis · Hypercholesterolaemia

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20242026202820302032
  1. Ph 3

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

    NCT06008756

    9 Oct 2023 to est. 29 Nov 2031

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Enlicitide DecanoateDrug
  • PlaceboDrug

Arms3

  • Experimental

    Blinded Portion: Enlicitide Decanoate

    Participants receive enlicitide decanoate 20 mg once daily.

  • Placebo comparator

    Blinded Portion: Placebo

    Participants receive placebo once daily.

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

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

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

    Registry description

    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 outcomes(17)

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

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

    Registry description

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

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

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

    Registry description

    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).

  3. Blinded Period: Time to 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

    Registry description

    Time to the first occurrence of CHD death or MI.

  4. Blinded Period: Time to CV Death

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

    Registry description

    Time to cardiovascular death.

  5. Blinded Period: Time to All-Cause Death

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

    Registry description

    Time to all-cause death.

  6. Blinded Period: Time to CHD Death

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

    Registry description

    Time to CHD death.

  7. Blinded Period: Time to First Event of MI

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

    Registry description

    Time to the first occurrence of MI.

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

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

    Registry description

    Time to the first occurrence of ischemic stroke.

  9. Blinded Period: Time to First Event 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

    Registry description

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

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

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

    Registry description

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

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

    Time frame · Baseline and Week 52

    Registry description

    The percent change from baseline in LDL-C.

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

    Time frame · Baseline and Week 52

    Registry description

    The percent change from baseline in apolipoprotein B.

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

    Time frame · Baseline and Week 52

    Registry description

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

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

    Time frame · Baseline and Week 52

    Registry description

    The percent change from baseline in lipoprotein (a).

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

    Time frame · Up to approximately 6 years

    Registry description

    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.

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

    Time frame · Up to approximately 6 years

    Registry description

    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.

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

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

    Registry description

    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).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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: * Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria, compound heterozygous FH, or double heterozygous FH * Has New York Heart Association Class IV heart failure, last known Left Ventricular Ejection Fraction ≤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 washout. * Has a fasting triglyceride value ≥400 mg/dL (≥4.52 mmol/L) at Visit 1 (Screening)

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