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Open-label Extension Study of Enlicitide Decanoate (MK-0616/Enlicitide Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-019) CORALreef Extension
Sponsor: Merck Sharp & Dohme LLC
Summary
This is an extension study to evaluate the longer-term safety and efficacy of enlicitide decanoate in adults with hypercholesterolemia who completed either study MK-0616-013 (NCT05952856), study MK-0616-017 (NCT05952869), or study MK-0616-018 (NCT06450366).
Official title: A Phase 3, Open-label Extension Study to Evaluate the Safety and Efficacy of MK-0616 in Adults With Hypercholesterolemia
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
3000
Start Date
2024-08-05
Completion Date
2028-10-13
Last Updated
2025-10-07
Healthy Volunteers
No
Conditions
Interventions
Enlicitide Decanoate
Oral tablet
Locations (222)
Alliance for Multispecialty Research, LLC ( Site 0027)
Daphne, Alabama, United States
G&L Research ( Site 0035)
Foley, Alabama, United States
Synexus Clinical Research US, Inc.-Synexus Clinical Research US, Inc - Central Phoenix ( Site 0048)
Phoenix, Arizona, United States
National Heart Institute-Research ( Site 0029)
Beverly Hills, California, United States
Clinical Trials Research ( Site 0054)
Sacramento, California, United States
Velocity Clinical Research, Banning ( Site 0023)
San Bernardino, California, United States
Emerson Clinical Research Institute ( Site 0017)
Washington D.C., District of Columbia, United States
Excel Medical Clinical Trials ( Site 0010)
Boca Raton, Florida, United States
Alliance for Multispecialty Research, LLC ( Site 0037)
Doral, Florida, United States
Alliance for Multispecialty Research, LLC ( Site 0056)
Fort Myers, Florida, United States
Velocity Clinical Research, Hallandale Beach ( Site 0053)
Hallandale, Florida, United States
Jacksonville Center for Clinical Research ( Site 0025)
Jacksonville, Florida, United States
South Broward Research ( Site 0012)
Miramar, Florida, United States
Progressive Medical Research ( Site 0033)
Port Orange, Florida, United States
Clinical Research Trials of Florida ( Site 0006)
Tampa, Florida, United States
Clinical Site Partners, LLC dba Flourish Research ( Site 0004)
Winter Park, Florida, United States
East Coast Institute for Research, LLC ( Site 0020)
Macon, Georgia, United States
Healthcare Research Network - Chicago ( Site 0051)
Flossmoor, Illinois, United States
Synexus Clinical Research US - Evansville ( Site 0005)
Evansville, Indiana, United States
Midwest Institute For Clinical Research ( Site 0052)
Indianapolis, Indiana, United States
Alliance for Multispecialty Research, LLC ( Site 0001)
Lexington, Kentucky, United States
L-MARC Research Center ( Site 0011)
Louisville, Kentucky, United States
Velocity Clinical Research, Covington ( Site 0026)
Covington, Louisiana, United States
Velocity Clinical Research Rockville ( Site 0022)
Rockville, Maryland, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0018)
Troy, Michigan, United States
Velocity Clinical Research, Gulfport ( Site 0032)
Gulfport, Mississippi, United States
Healthcare Research Network - St. Louis ( Site 0040)
Hazelwood, Missouri, United States
Velocity Clinical Research at The Pioneer Heart Institute, Lincoln ( Site 0031)
Lincoln, Nebraska, United States
Jubilee Clinical Research ( Site 0049)
Las Vegas, Nevada, United States
AB Clinical Trials ( Site 0002)
Las Vegas, Nevada, United States
New Mexico Clinical Research & Osteoporosis Center ( Site 0043)
Albuquerque, New Mexico, United States
Velocity Clinical Research, Syracuse ( Site 0014)
East Syracuse, New York, United States
Icahn School of Medicine at Mount Sinai-Cardiology ( Site 0042)
New York, New York, United States
Lillestol Research ( Site 0030)
Fargo, North Dakota, United States
altoona center for clinical research ( Site 0024)
Duncansville, Pennsylvania, United States
Cardiology Consultants of Philadelphia Yardley ( Site 0021)
Yardley, Pennsylvania, United States
Velocity Clinical Research, Anderson ( Site 0015)
Anderson, South Carolina, United States
Piedmont Research Partners ( Site 0045)
Fort Mill, South Carolina, United States
Coastal Carolina Research Center ( Site 0055)
North Charleston, South Carolina, United States
Monument Health Clinical Research, a department of Monument -Monument Health Clinical Research, a d ( Site 0038)
Rapid City, South Dakota, United States
Holston Medical Group ( Site 0034)
Kingsport, Tennessee, United States
Alliance for Multispecialty Research, LLC ( Site 0050)
Knoxville, Tennessee, United States
Velocity Clinical Research, Dallas ( Site 0028)
Dallas, Texas, United States
Center for Cardiometabolic Disease Prevention/Baylor College of Medicine ( Site 0009)
Houston, Texas, United States
Clinical Trials of Texas, LLC ( Site 0016)
San Antonio, Texas, United States
Synexus Clinical Research US, Inc. ( Site 0003)
Salt Lake City, Utah, United States
Velocity Clinical Research, Salt Lake City ( Site 0041)
West Jordan, Utah, United States
Manassas Clinical Research Center ( Site 0007)
Manassas, Virginia, United States
Health Research of Hampton Roads, Inc. ( Site 0019)
Newport News, Virginia, United States
Alliance for Multispecialty Research, LLC ( Site 0008)
Norfolk, Virginia, United States
National Clinical Research, Inc ( Site 0044)
Richmond, Virginia, United States
Rainier Clinical Research Center ( Site 0013)
Renton, Washington, United States
CEDIC ( Site 0603)
CABA, Buenos Aires, Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0605)
CABA, Buenos Aires, Argentina
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0602)
Mar del Plata, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Zarate ( Site 0604)
Zárate, Buenos Aires, Argentina
Fundacion Estudios Clinicos ( Site 0601)
Rosario, Santa Fe Province, Argentina
Centro de Investigaciones Metabolicas CINME - Cardiology ( Site 0607)
CABA, Argentina
CIPREC ( Site 0600)
CABA, Argentina
Fundación Respirar ( Site 0606)
CABA, Argentina
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 ( Site 0701)
São Paulo, São Paulo, Brazil
Incor - Instituto do Coracao ( Site 0703)
São Paulo, Brazil
The Medical Arts Health Research Group ( Site 0506)
North Vancouver, British Columbia, Canada
Cambridge Cardiac Care Centre ( Site 0502)
Cambridge, Ontario, Canada
North York Diagnostic and Cardiac Centre ( Site 0505)
North York, Ontario, Canada
Ecogene-21 ( Site 0500)
Chicoutimi, Quebec, Canada
Institut de Cardiologie de Montreal ( Site 0504)
Montreal, Quebec, Canada
Diex Recherche Trois-Rivieres ( Site 0503)
Trois-Rivières, Quebec, Canada
Clinical Research Chile SpA ( Site 0800)
Valdivia, Los Ríos Region, Chile
CDIEM ( Site 0801)
Providencia, Region M. de Santiago, Chile
Pontificia Universidad Catolica de Chile-CICUC ( Site 0803)
Santiago, Region M. de Santiago, Chile
Beijing Anzhen Hospital, Capital Medical University-Cardiovascular ( Site 6000)
Beijing, Beijing Municipality, China
Beijing Friendship Hospital Affiliate of Capital University ( Site 6003)
Beijing, Beijing Municipality, China
The Second Affiliated Hospital of Chongqing Medical University ( Site 6020)
Chongqing, Chongqing Municipality, China
Chongqing University Three Gorges Hospital ( Site 6021)
Chongqing, Chongqing Municipality, China
Guangdong Provincial People s Hospital ( Site 6004)
Guangzhou, Guangdong, China
Zhujiang Hospital ( Site 6029)
Guangzhou, Guangdong, China
Huizhou Municipal Central Hospital ( Site 6079)
Huizhou, Guangdong, China
The University of Hong Kong-Shenzhen Hospital ( Site 6018)
Shenzhen, Guangdong, China
Jingzhou Central Hospital ( Site 6076)
Jingzhou, Hubei, China
Wuhan Fourth Hospital ( Site 6056)
Wuhan, Hubei, China
Hunan Provincial People's Hospital ( Site 6017)
Changsha, Hunan, China
Changzhou Second People's Hospital ( Site 6073)
Changzhou, Jiangsu, China
Northern Jiangsu People s Hospital ( Site 6008)
Yangzhou, Jiangsu, China
The Third Hospital of Nanchang - Fuhe ( Site 6078)
Nanchang, Jiangxi, China
Siping Central People's Hospital ( Site 6011)
Siping, Jilin, China
Xianyang Hospital of Yan'an University ( Site 6040)
Xianyang, Shaanxi, China
Chengdu Second Municipal People's Hospital ( Site 6032)
Chengdu, Sichuan, China
Lishui City People s Hospital ( Site 6002)
Lishui, Zhejiang, China
Fundación Centro de Investigación Clínica CIC ( Site 0904)
Medellín, Antioquia, Colombia
Ciensalud Ips S A S ( Site 0900)
Barranquilla, Atlántico, Colombia
Clinica de la Costa S.A.S. ( Site 0901)
Barranquilla, Atlántico, Colombia
Salud SURA Calle 100 ( Site 0905)
Bogotá, Cundinamarca, Colombia
Healthy Medical Center S.A.S ( Site 0902)
Zipaquirá, Cundinamarca, Colombia
Fundación Valle del Lili ( Site 0903)
Cali, Valle del Cauca Department, Colombia
Fakultni Nemocnice u sv. Anny v Brne ( Site 3604)
Brno, Brno-mesto, Czechia
Fakultní nemocnice Brno Bohunice-Interni kardiologicka klinika ( Site 3602)
Brno, Brno-mesto, Czechia