A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017) CORALreef HeFH
NCT ID: NCT05952869
Last Updated: 2025-05-13
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
303 participants
INTERVENTIONAL
2023-08-08
2025-04-07
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 will receive 20 mg of enlicitide decanoate orally once daily (QD) for up to 52 weeks.
Enlicitide Decanoate
Oral tablet
Placebo
Participants will receive enlicitide decanoate-matching placebo orally QD for up to 52 weeks.
Placebo
Placebo
Interventions
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Enlicitide Decanoate
Oral tablet
Placebo
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has an LDL-C ≥55 mg/dL or ≥70 mg/dL depending on medical history
* Is treated with a moderate- or high-intensity statin medication
* Is on a stable dose of all background lipid-lowering therapies (LLTs) with no planned medication change
Exclusion Criteria
* Has a history of heart failure or heart failure hospitalization within 3 months before first study visit
* Is undergoing or previously underwent an LDL-C apheresis program within 3 months before first study visit 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
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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Alliance for Multispecialty Research, LLC ( Site 0023)
Daphne, Alabama, United States
Excel Medical Clinical Trials ( Site 0008)
Boca Raton, Florida, United States
Advanced Pharma Research ( Site 0007)
Cutler Bay, Florida, United States
Progressive Medical Research ( Site 0021)
Port Orange, Florida, United States
Clinical Site Partners LLC, dba CSP Orlando ( Site 0028)
Winter Park, Florida, United States
Synexus Clinical Research US - Evansville ( Site 0031)
Evansville, Indiana, United States
Franciscan Physician Network - Indiana Heart Physicians ( Site 0040)
Indianapolis, Indiana, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0001)
Troy, Michigan, United States
Velocity Clinical Research at The Pioneer Heart Institute, Lincoln ( Site 0026)
Lincoln, Nebraska, United States
Jubilee Clinical Research ( Site 0030)
Las Vegas, Nevada, United States
Wake Forest Baptist Health-Cardiovascular Medicine ( Site 0041)
Winston-Salem, North Carolina, United States
Velocity Clinical Research, Salt Lake City ( Site 0004)
West Jordan, Utah, United States
Health Research of Hampton Roads, Inc. ( Site 0020)
Newport News, Virginia, United States
Royal Prince Alfred Hospital-6West CV Ambulatory Care ( Site 2808)
Camperdown, New South Wales, Australia
Victorian Heart Hospital-Monash Cardiovascular Research Centre (MCRC) ( Site 2803)
Clayton, Victoria, Australia
Universidade Federal Do Ceara ( Site 0702)
Fortaleza, Ceará, Brazil
Instituto Dante Pazzanese de Cardiology-Fundação Adib Jatene ( Site 0701)
São Paulo, São Paulo, Brazil
Incor - Instituto do Coracao ( Site 0703)
São Paulo, , Brazil
Ecogene-21 ( Site 0510)
Chicoutimi, Quebec, Canada
Institut de Cardiologie de Montreal ( Site 0506)
Montreal, Quebec, Canada
Diex Recherche Trois-Rivieres ( Site 0513)
Trois-Rivières, Quebec, Canada
Clinical Research Chile SpA ( Site 0804)
Valdivia, Los Ríos Region, Chile
CDIEM ( Site 0814)
Providencia, Region M. de Santiago, Chile
Enroll SpA ( Site 0803)
Santiago, Region M. de Santiago, Chile
Pontificia Universidad Catolica de Chile-CICUC ( Site 0812)
Santiago, Region M. de Santiago, Chile
Fundación Centro de Investigación Clínica CIC ( Site 0906)
Medellín, Antioquia, Colombia
Ciensalud Ips S A S ( Site 0903)
Barranquilla, Atlántico, Colombia
Clinica de la Costa S.A.S. ( Site 0902)
Barranquilla, Atlántico, Colombia
Salud SURA Calle 100 ( Site 0918)
Bogotá, Cundinamarca, Colombia
Fakultní nemocnice Brno Bohunice-Interni kardiologicka klinika ( Site 3602)
Brno, Brno-mesto, Czechia
Institut Klinicke a Experimentalni Mediciny ( Site 3601)
Prague, Praha 4, Czechia
Fakultni Nemocnice u sv. Anny v Brne ( Site 3604)
Brno, South Moravian, Czechia
Meilahden tornisairaala - Meilahti Tower Hospital ( Site 1300)
Helsinki, Uusimaa, Finland
Queen Mary Hospital-Medical ( Site 3300)
Pok Fu Lam, , Hong Kong
Prince of Wales Hospital ( Site 3304)
Shatin, , Hong Kong
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Belgyógyászati Klinika ( Site 1603)
Szeged, Csongrád megye, Hungary
Semmelweis Egyetem-Városmajori Szív- és Érgyógyászati Klinika ( Site 1600)
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Anyagcsere Tanszék) ( Site 1601)
Debrecen, , Hungary
Shaare Zedek Medical Center ( Site 1710)
Jerusalem, , Israel
Hadassah Medical Center ( Site 1709)
Jerusalem, , Israel
Rabin Medical Center ( Site 1717)
Petah Tikva, , Israel
Clalit Health Services - Sakhnin Community Clinic-Research Unit ( Site 1700)
Sakhnin, , Israel
Radboudumc-internal medicine ( Site 1952)
Nijmegen, Gelderland, Netherlands
Amsterdam UMC, locatie AMC-Vascular Medicine Clin Trial Unit ( Site 1954)
Amsterdam, North Holland, Netherlands
Vasculair Onderzoek Centrum Hoorn ( Site 1953)
Hoorn, North Holland, Netherlands
Universitair Medisch Centrum Utrecht-Vascular Medicine Research ( Site 1955)
Utrecht, , Netherlands
Pacific Clinical Research Network - Rotorua ( Site 2902)
Rotorua, Bay of Plenty, New Zealand
New Zealand Clinical Research (Christchurch) ( Site 2901)
Christchurch, Canterbury, New Zealand
Nordlandssykehuset ( Site 2001)
Bodø, Nordland, Norway
Oslo Universitetssykehus Aker-Lipidklinikken ( Site 2000)
Oslo, , Norway
National University Hospital-Department of Medicine ( Site 3212)
Singapore, Central Singapore, Singapore
Changi General Hospital ( Site 3211)
Singapore, Central Singapore, Singapore
Hospital de Sant Joan Despí Moisès Broggi ( Site 2335)
Sant Joan Despí, Catalonia, Spain
SALUT SANT JOAN DE REUS-BAIX CAMP (EDP)-Vascular and Metabolism Unit ( Site 2329)
Reus, Tarragona, Spain
HOSPITAL CLINICO DE VALENCIA ( Site 2321)
Valencia, Valenciana, Comunitat, Spain
Mackay Memorial Hospital -Tamshui Branch ( Site 3109)
New Taipei City, New Taipei, Taiwan
Shin Kong Wu Ho-Su Memorial Hospital ( Site 3106)
Taipei City, Taipei, Taiwan
National Cheng Kung University Hospital-Internal Medicine ( Site 3107)
Tainan City, , Taiwan
National Taiwan University Hospital ( Site 3100)
Taipei, , Taiwan
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-0616-017
Identifier Type: OTHER
Identifier Source: secondary_id
2022-502782-14-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1285-4257
Identifier Type: REGISTRY
Identifier Source: secondary_id
0616-017
Identifier Type: -
Identifier Source: org_study_id
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