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NCT06450366CompletedPhase 3

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

A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of MK-0616 Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia

Source: ClinicalTrials.gov · Last updated 27 Mar 2026

Brief summary (registry, in English)

The main purpose of this study is to assess whether enlicitide is superior to ezetimibe or bempedoic acid or ezetimibe + bempedoic acid in reducing low-density lipoprotein cholesterol (LDL-C) in participants with hypercholesterolemia, and to evaluate its safety and tolerability. The primary study hypotheses are enlicitide is superior to ezetimibe, bempedoic acid, and ezetimibe + bempedoic acid on mean percent change from baseline in LDL-C at week 8.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
301 (actual)
First submitted
4 Jun 2024
Start date
8 Jul 2024
Primary completion date
14 Feb 2025
Lead sponsor
Merck Sharp & Dohme LLC
NCT number
NCT06450366
EU CT number
2023-504920-25-00

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 301
  • From 8 Jul 2024 to the primary completion date, 14 Feb 2025
  • 35 sites in 8 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 ezetimibe, bempedoic acid, or protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors without adequate washout

Other illness

  • Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria, compound heterozygous familial hypercholesterolemia (HeFH), or double HeFH
  • Participants with a history of tendon disorder or tendon rupture
  • Participants with a history of gout

Lab values

  • Has New York Heart Association class IV heart failure, or last known left ventricular ejection fraction ≤25% by any imaging method, or had a heart failure hospitalization within 3 months before Visit 1 (Screening)

Who the study is looking for

  • Has either a) history of a major atherosclerotic cardiovascular disease (ASCVD) event or b) if no history of a major ASCVD event, has intermediate to high risk for development of a first major ASCVD event
  • Has fasted lipid values (evaluated by the central laboratory) at Visit 1 (Screening) as follows: a) history of a major ASCVD event with LDL-C ≥55 mg/dL (≥1.42 mmol/L) OR b) No history of a major ASCVD event with low-density lipoprotein cholesterol (LDL-C) ≥70 mg/dL (≥1.81 mmol/L)
  • Is treated with a low, moderate, or high intensity statin (±non-statin lipid lowering therapy \[LLT\])
  • Is on a stable dose of all background LLTs with no planned medication or dose changes during the study
  • Is an individual of any sex/gender, from 18 years of age inclusive, at the time of providing the informed consent

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (35)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CIPREC-CIPREC Sede Arenales ( Site 1000)
Coordinator of this site? Confirm its status
Buenos AiresArgentinaUnknown status
Instituto de Investigaciones Clínicas Mar del Plata ( Site 1002)
Coordinator of this site? Confirm its status
Mar del PlataArgentinaUnknown status
Fundacion Estudios Clinicos ( Site 1001)
Coordinator of this site? Confirm its status
RosarioArgentinaUnknown status
Cambridge Cardiac Care Centre ( Site 1603)
Coordinator of this site? Confirm its status
CambridgeCanadaUnknown status
Institut de Cardiologie de Montreal ( Site 1604)
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status
North York Diagnostic and Cardiac Centre ( Site 1605)
Coordinator of this site? Confirm its status
North YorkCanadaUnknown status
Diex Recherche Trois-Rivieres ( Site 1602)
Coordinator of this site? Confirm its status
Trois-RivièresCanadaUnknown status
The Medical Arts Health Research Group ( Site 1606)
Coordinator of this site? Confirm its status
VancouverCanadaUnknown status
Instituto Medico Quirurgico San Rafael S.A.
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A CorunaSpainCompleted
Equip D'atencio Primaria Barcelona Sardenya S.L.P.
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BarcelonaSpainCompleted
Hospital Universitari Vall d'Hebron
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BarcelonaSpainCompleted
Fundacio Salut Emporda
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FigueresSpainCompleted
Hospital Universitario Virgen de la Victoria
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MálagaSpainCompleted
Hospices Civils de Lyon
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BronFranceCompleted
Centre Hospitalier Universitaire de Montpellier
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MontpellierFranceCompleted
Assistance Publique Hopitaux De Paris
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Paris Cedex 18FranceCompleted
Institut De Cancerologie De L Ouest
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St HerblainFranceCompleted
National Institute for Health Research UCLH Clinical Research Facility ( Site 0908)
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LondonUnited KingdomUnknown status
Barts Health NHS Trust-William Harvey Clinical Research Centre ( Site 0901)
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LondonUnited KingdomUnknown status
Royal Free Hospital ( Site 0900)
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LondonUnited KingdomUnknown status
Assuta Beersheba MC ( Site 0704)
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BeershebaIsraelUnknown status
Yitzhak Shamir Medical Center. ( Site 0702)
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Beer YaakovIsraelUnknown status
Rambam Health Care Campus ( Site 0700)
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HaifaIsraelUnknown status
Meir Medical Center. ( Site 0703)
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Kfar SabaIsraelUnknown status
National Cheng Kung University Hospital-Internal Medicine ( Site 0403)
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TainanTaiwanUnknown status
Taipei Veterans General Hospital-Department of Medicine ( Site 0402)
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TaipeiTaiwanUnknown status
National Taiwan University Hospital ( Site 0400)
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TaipeiTaiwanUnknown status
Chang Gung Medical Foundation-Linkou Branch ( Site 0404)
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TaoyuanTaiwanUnknown status
Healthcare Research Network - Chicago ( Site 1507)
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FlossmoorUnited StatesUnknown status
Piedmont Research Partners ( Site 1506)
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Fort MillUnited StatesUnknown status
Velocity Clinical Research, Gulfport ( Site 1505)
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GulfportUnited StatesUnknown status
Clinical Trials Research ( Site 1509)
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LincolnUnited StatesUnknown status
L-MARC Research Center ( Site 1501)
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LouisvilleUnited StatesUnknown status
Rainier Clinical Research Center ( Site 1502)
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RentonUnited StatesUnknown status
Velocity Clinical Research Rockville ( Site 1503)
Coordinator of this site? Confirm its status
RockvilleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.