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A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-013) CORALreef Lipids
Sponsor: Merck Sharp & Dohme LLC
Summary
The goal of this study is to evaluate the efficacy, safety, and tolerability of enlicitide decanoate in adult participants with hypercholesterolemia. The primary hypothesis is that enlicitide decanoate is superior to placebo on mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24.
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-0616 in Adults With Hypercholesterolemia
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
2912
Start Date
2023-08-10
Completion Date
2025-07-28
Last Updated
2026-09-24
Healthy Volunteers
No
Interventions
Enlicitide Decanoate
Oral tablet
Placebo
Oral tablet
Locations (168)
Alliance for Multispecialty Research, LLC ( Site 0093)
Daphne, Alabama, United States
G&L Research ( Site 0043)
Foley, Alabama, United States
Synexus Clinical Research US, Inc.-Synexus Clinical Research US, Inc - Central Phoenix ( Site 0084)
Phoenix, Arizona, United States
National Heart Institute-Research ( Site 0087)
Beverly Hills, California, United States
Clinical Trials Research ( Site 0115)
Sacramento, California, United States
Velocity Clinical Research, Banning ( Site 0017)
San Bernardino, California, United States
Emerson Clinical Research Institute ( Site 0118)
Washington D.C., District of Columbia, United States
Excel Medical Clinical Trials ( Site 0053)
Boca Raton, Florida, United States
Alliance for Multispecialty Research, LLC ( Site 0088)
Coral Gables, Florida, United States
Alliance for Multispecialty Research, LLC ( Site 0094)
Fort Myers, Florida, United States
Velocity Clinical Research, Hallandale Beach ( Site 0018)
Hallandale, Florida, United States
Jacksonville Center for Clinical Research ( Site 0049)
Jacksonville, Florida, United States
South Broward Research ( Site 0051)
Miramar, Florida, United States
Clinical Research Trials of Florida ( Site 0063)
Tampa, Florida, United States
East Coast Institute for Research, LLC ( Site 0033)
Macon, Georgia, United States
Healthcare Research Network - Chicago ( Site 0052)
Flossmoor, Illinois, United States
Synexus Clinical Research US, Inc. ( Site 0109)
Evansville, Indiana, United States
Midwest Institute For Clinical Research ( Site 0059)
Indianapolis, Indiana, United States
Alliance for Multispecialty Research, LLC ( Site 0028)
Lexington, Kentucky, United States
L-MARC Research Center ( Site 0001)
Louisville, Kentucky, United States
Velocity Clinical Research, Covington ( Site 0068)
Covington, Louisiana, United States
Velocity Clinical Research Rockville ( Site 0082)
Rockville, Maryland, United States
Velocity Clinical Research, Gulfport ( Site 0039)
Gulfport, Mississippi, United States
Healthcare Research Network - St. Louis ( Site 0054)
Hazelwood, Missouri, United States
Jubilee Clinical Research ( Site 0106)
Las Vegas, Nevada, United States
AB Clinical Trials ( Site 0070)
Las Vegas, Nevada, United States
New Mexico Clinical Research & Osteoporosis Center ( Site 0005)
Albuquerque, New Mexico, United States
Velocity Clinical Research, Syracuse ( Site 0021)
East Syracuse, New York, United States
Icahn School of Medicine at Mount Sinai-Cardiology ( Site 0002)
New York, New York, United States
Lillestol Research ( Site 0026)
Fargo, North Dakota, United States
altoona center for clinical research ( Site 0089)
Duncansville, Pennsylvania, United States
Cardiology Consultants of Philadelphia Yardley ( Site 0097)
Yardley, Pennsylvania, United States
Piedmont Research Partners ( Site 0090)
Fort Mill, South Carolina, United States
Velocity Clinical Research, Greenville ( Site 0023)
Greenville, South Carolina, United States
Coastal Carolina Research Center ( Site 0006)
North Charleston, South Carolina, United States
Monument Health Clinical Research, a department of Monument -Monument Health Clinical Research, a d ( Site 0009)
Rapid City, South Dakota, United States
Holston Medical Group ( Site 0048)
Kingsport, Tennessee, United States
Alliance for Multispecialty Research, LLC ( Site 0008)
Knoxville, Tennessee, United States
Velocity Clinical Research, Dallas ( Site 0114)
Dallas, Texas, United States
Center for Cardiometabolic Disease Prevention/Baylor College of Medicine ( Site 0111)
Houston, Texas, United States
Clinical Trials of Texas, LLC ( Site 0103)
San Antonio, Texas, United States
Synexus Clinical Research US, Inc. ( Site 0110)
Salt Lake City, Utah, United States
Velocity Clinical Research, Salt Lake City ( Site 0019)
West Jordan, Utah, United States
Manassas Clinical Research Center ( Site 0007)
Manassas, Virginia, United States
Health Research of Hampton Roads, Inc. ( Site 0044)
Newport News, Virginia, United States
Alliance for Multispecialty Research, LLC ( Site 0101)
Norfolk, Virginia, United States
National Clinical Research, Inc ( Site 0061)
Richmond, Virginia, United States
Centricity Research Suffolk Family Medicine ( Site 0092)
Suffolk, Virginia, United States
Rainier Clinical Research Center ( Site 0116)
Renton, Washington, United States
CEDIC ( Site 0612)
CABA, Buenos Aires, Argentina
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0605)
Mar del Plata, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Zarate ( Site 0600)
Zárate, Buenos Aires, Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0604)
Buenos Aires, Buenos Aires F.D., Argentina
Fundación Respirar ( Site 0610)
Buenos Aires, Buenos Aires F.D., Argentina
Centro de Investigaciones Metabólicas (CINME)-Cardiology ( Site 0620)
CABA, Argentina
Beijing Anzhen Hospital, Capital Medical University-Cardiovascular ( Site 3300)
Beijing, Beijing Municipality, China
Beijing Friendship Hospital Affiliate of Capital University-Cardiology ( Site 3303)
Beijing, Beijing Municipality, China
The Second Affiliated Hospital of Chongqing Medical University ( Site 3320)
Chongqing, Chongqing Municipality, China
Chongqing University Three Gorges Hospital ( Site 3321)
Chongqing, Chongqing Municipality, China
Guangdong Provincial People's Hospital-Cardiology ( Site 3304)
Guangzhou, Guangdong, China
Zhujiang Hospital of Southern Medical University ( Site 3329)
Guangzhou, Guangdong, China
Huizhou Municipal Central Hospital ( Site 3379)
Huizhou, Guangdong, China
The University of Hong Kong-Shenzhen Hospital-Cardiovascular department ( Site 3318)
Shenzhen, Guangdong, China
Jingzhou Central Hospital-Cardiology ( Site 3376)
Jingzhou, Hubei, China
Wuhan Fourth Hospital ( Site 3356)
Wuhan, Hubei, China
Hunan Provincial People's Hospital-Cardiology ( Site 3317)
Changsha, Hunan, China
Changzhou Second People's Hospital-Cardiology ( Site 3373)
Changzhou, Jiangsu, China
Northern Jiangsu People's Hospital ( Site 3308)
Yangzhou, Jiangsu, China
The Third Hospital of Nanchang - Fuhe-cardiology ( Site 3378)
Nanchang, Jiangxi, China
Siping Central People's Hospital-Cardiovascular Department ( Site 3311)
Siping, Jilin, China
Xianyang Hospital of Yan'an University ( Site 3340)
Xianyang, Shaanxi, China
Chengdu Second Municipal People's Hospital ( Site 3332)
Chengdu, Sichuan, China
People's Hospital of Lishui City-department of cardiovascular ( Site 3302)
Lishui, Zhejiang, China
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
Healthy Medical Center S.A.S ( Site 0913)
Zipaquirá, Cundinamarca, Colombia
Fundación Valle del Lili ( Site 0904)
Cali, Valle del Cauca Department, Colombia
Unterfrintroper Hausarztzentrum Klinische Forschung ( Site 1542)
Essen, North Rhine-Westphalia, Germany
Universitaetsklinikum Carl Gustav Carus Dresden-Universitätsstudienzentrum für Stoffwechselerkranku ( Site 1508)
Dresden, Saxony, Germany
Hausarzt- und Diabetologische Schwerpunktpraxis Hohenmölsen - Weiβenfels ( Site 1527)
Hohenmölsen, Saxony-Anhalt, Germany
Zentralklinik Bad Berka ( Site 1530)
Bad Berka, Thuringia, Germany
Velocity Clinical Research GmbH Berlin ( Site 1502)
Berlin, Germany
Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 1533)
Berlin, Germany
Hillel Yaffe Medical Center ( Site 1705)
Hadera, Israel
Rambam Health Care Campus-internal department ( Site 1718)
Haifa, Israel
Shaare Zedek Medical Center ( Site 1710)
Jerusalem, Israel
Hadassah Medical Center ( Site 1706)
Jerusalem, Israel
Hadassah Medical Center ( Site 1709)
Jerusalem, Israel
Meir Medical Center. ( Site 1714)
Kfar Saba, Israel
Rabin Medical Center ( Site 1720)
Petah Tikva, Israel
Sheba Medical Center ( Site 1708)
Ramat Gan, Israel
Yitzhak Shamir Medical Center. ( Site 1712)
Ẕerifin, Israel
Fondazione Policlinico Tor Vergata ( Site 1809)
Rome, Lazio, Italy
Centro Cardiologico Monzino ( Site 1804)
Milan, Milano, Italy
ASST Grande Ospedale Metropolitano Niguarda-Unità Ricerche Cliniche della Cardiologia 4 ( Site 1811)
Milan, Milano, Italy
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino ( Site 1801)
Turin, Piedmont, Italy
Azienda Ospedaliera Sant'Andrea-Department of Clinical and Molecular Medicine ( Site 1807)
Rome, Roma, Italy
Azienda Ospedaliera Garibaldi ( Site 1810)
Catania, Italy