A Study to Evaluate the Efficacy and Safety of Enlicitide Decanoate (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
NCT ID: NCT06450366
Last Updated: 2025-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
301 participants
INTERVENTIONAL
2024-07-08
2025-03-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Enlicitide Decanoate
Participants receive enlicitide decanoate 20mg, ezetimibe-matching placebo, and bempedoic acid-matching placebo once daily (QD) orally up to approximately 56 days.
Enlicitide Decanoate
Administered orally.
Placebo for Ezetimibe
Administered orally.
Placebo for Bempedoic Acid
Administered orally.
Ezetimibe
Participants receive ezetimibe 10mg, enlicitide decanoate-matching placebo, and bempedoic acid-matching placebo QD orally up to approximately 56 days.
Ezetimibe
Administered orally.
Placebo for Enlicitide Decanoate
Administered orally.
Placebo for Bempedoic Acid
Administered orally.
Bempedoic Acid
Participants receive bempedoic acid 180mg, ezetimibe-matching placebo, and enlicitide decanoate-matching placebo QD orally up to approximately 56 days.
Bempedoic Acid
Administered orally.
Placebo for Enlicitide Decanoate
Administered orally.
Placebo for Ezetimibe
Administered orally.
Ezetimibe + Bempedoic Acid
Participants receive ezetimibe 10 mg, bempedoic acid 180mg, enlicitide decanoate-matching placebo orally QD for approximately 56 days.
Ezetimibe
Administered orally.
Bempedoic Acid
Administered orally.
Placebo for Enlicitide Decanoate
Administered orally.
Interventions
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Enlicitide Decanoate
Administered orally.
Ezetimibe
Administered orally.
Bempedoic Acid
Administered orally.
Placebo for Enlicitide Decanoate
Administered orally.
Placebo for Ezetimibe
Administered orally.
Placebo for Bempedoic Acid
Administered orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
Exclusion Criteria
* 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)
* Participants with a history of tendon disorder or tendon rupture
* Participants with a history of gout
* 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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Clinical Trials Research ( Site 1509)
Lincoln, California, United States
Healthcare Research Network - Chicago ( Site 1507)
Flossmoor, Illinois, United States
L-MARC Research Center ( Site 1501)
Louisville, Kentucky, United States
Velocity Clinical Research Rockville ( Site 1503)
Rockville, Maryland, United States
Velocity Clinical Research, Gulfport ( Site 1505)
Gulfport, Mississippi, United States
Piedmont Research Partners ( Site 1506)
Fort Mill, South Carolina, United States
Rainier Clinical Research Center ( Site 1502)
Renton, Washington, United States
Instituto de Investigaciones Clínicas Mar del Plata ( Site 1002)
Mar del Plata, Buenos Aires, Argentina
CIPREC-CIPREC Sede Arenales ( Site 1000)
Buenos Aires, Buenos Aires F.D., Argentina
Fundacion Estudios Clinicos ( Site 1001)
Rosario, Santa Fe Province, Argentina
The Medical Arts Health Research Group ( Site 1606)
Vancouver, British Columbia, Canada
Cambridge Cardiac Care Centre ( Site 1603)
Cambridge, Ontario, Canada
North York Diagnostic and Cardiac Centre ( Site 1605)
North York, Ontario, Canada
Institut de Cardiologie de Montreal ( Site 1604)
Montreal, Quebec, Canada
Diex Recherche Trois-Rivieres ( Site 1602)
Trois-Rivières, Quebec, Canada
Hôpital Arnaud de Villeneuve - CHU Montpellier ( Site 0505)
Montpellier, Herault, France
Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes-CIC Endocrinology-Diabetology-Nutrition ( Sit
Nantes, Loire-Atlantique, France
Hospices Civils de Lyon - Hopital Louis Pradel ( Site 0501)
Bron, Rhone, France
Hôpital Bichat - Claude-Bernard ( Site 0504)
Paris, , France
Yitzhak Shamir Medical Center. ( Site 0702)
Beer Yaakov, , Israel
Assuta Beersheba MC ( Site 0704)
Beersheba, , Israel
Rambam Health Care Campus ( Site 0700)
Haifa, , Israel
Meir Medical Center. ( Site 0703)
Kfar Saba, , Israel
Hospital Universitario Virgen de la Victoria-UGC Endocrinologia y nutricion ( Site 0801)
Málaga, Andalusia, Spain
Hospital de Figueres ( Site 0804)
Figueres, Gerona, Spain
Hospital San Rafael de Coruna ( Site 0805)
A Coruña, La Coruna, Spain
EAP Sardenya ( Site 0800)
Barcelona, , Spain
Hospital Universitari Vall d'Hebron ( Site 0803)
Barcelona, , Spain
National Cheng Kung University Hospital-Internal Medicine ( Site 0403)
Tainan City, , Taiwan
National Taiwan University Hospital ( Site 0400)
Taipei, , Taiwan
Taipei Veterans General Hospital-Department of Medicine ( Site 0402)
Taipei, , Taiwan
Chang Gung Medical Foundation-Linkou Branch ( Site 0404)
Taoyuan District, , Taiwan
Barts Health NHS Trust-William Harvey Clinical Research Centre ( Site 0901)
London, England, United Kingdom
Royal Free Hospital ( Site 0900)
London, England, United Kingdom
National Institute for Health Research UCLH Clinical Research Facility ( Site 0908)
London, London, City of, United Kingdom
Countries
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Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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MK-0616-018
Identifier Type: OTHER
Identifier Source: secondary_id
2023-504920-25
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1290-3888
Identifier Type: REGISTRY
Identifier Source: secondary_id
0616-018
Identifier Type: -
Identifier Source: org_study_id
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