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Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Cardiovascular Outcomes Study (MK-0616-015) CORALreef Outcomes
Sponsor: Merck Sharp & Dohme LLC
Summary
This is a phase 3, randomized, placebo-controlled study of the efficacy and safety of enlicitide decanoate, an oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, in participants with high cardiovascular risk. The primary objective is to evaluate the efficacy of enlicitide decanoate compared with placebo in increasing the time to the first occurrence of major adverse cardiovascular events (MACE) including coronary heart disease (CHD) death, ischemic stroke, myocardial infarction (MI), acute limb ischemia or major amputation, or urgent arterial revascularization.
Official title: Phase 3 Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of MK-0616 in Reducing Major Adverse Cardiovascular Events in Participants at High Cardiovascular Risk
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
14550
Start Date
2023-10-09
Completion Date
2031-11-29
Last Updated
2026-04-23
Healthy Volunteers
No
Conditions
Interventions
Enlicitide Decanoate
Enlicitide Decanoate 20 mg tablet taken by mouth.
Placebo
Placebo tablet matched to enlicitide decanoate taken by mouth.
Locations (669)
Advanced Cardiovascular - Alexander City ( Site 0156)
Alexander City, Alabama, United States
Central Research Associates ( Site 0118)
Birmingham, Alabama, United States
St. Vincent's Birmingham Hospital ( Site 0181)
Birmingham, Alabama, United States
Central Alabama Research ( Site 0109)
Birmingham, Alabama, United States
Alliance for Multispecialty Research, LLC ( Site 0076)
Daphne, Alabama, United States
G&L Research ( Site 0042)
Foley, Alabama, United States
NextStage Clinical Research - Phoenix - (01) ( Site 0191)
Glendale, Arizona, United States
Synexus Clinical Research US, Inc.-Synexus Clinical Research US, Inc - Central Phoenix ( Site 0066)
Phoenix, Arizona, United States
Medical Investigations Inc. ( Site 0188)
Little Rock, Arkansas, United States
National Heart Institute-Research ( Site 0077)
Beverly Hills, California, United States
UCSD - Altman Clinical and Translational Research Institute (ACTRI) ( Site 0130)
La Jolla, California, United States
Chemidox Clinical Trials ( Site 0145)
Lancaster, California, United States
Velocity Clinical Research, Westlake ( Site 0039)
Los Angeles, California, United States
Carbon Health - Pasadena ( Site 0149)
Pasadena, California, United States
Carbon Health - San Mateo - Hillsdale Mall ( Site 0151)
San Mateo, California, United States
America Clinical Trials-Research Dept ( Site 0104)
Tarzana, California, United States
Premiere Medical Center ( Site 0093)
Toluca Lake, California, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center ( Site 0058)
Torrance, California, United States
University of Colorado Anschutz Medical Campus-University of Colorado Hospital Cardiac and Vascular ( Site 0146)
Aurora, Colorado, United States
South Denver Cardiology Associates ( Site 0167)
Littleton, Colorado, United States
Cardiology Associates of Fairfield County, P.C. ( Site 0159)
Stamford, Connecticut, United States
Chase Medical Research, LLC ( Site 0046)
Waterbury, Connecticut, United States
Emerson Clinical Research Institute ( Site 0143)
Washington D.C., District of Columbia, United States
Excel Medical Clinical Trials ( Site 0052)
Boca Raton, Florida, United States
Advanced Pharma Research ( Site 0040)
Cutler Bay, Florida, United States
Alliance for Multispecialty Research, LLC ( Site 0083)
Fort Myers, Florida, United States
Westside Center for Clinical Research ( Site 0049)
Jacksonville, Florida, United States
University of Florida - Jacksonville ( Site 0166)
Jacksonville, Florida, United States
East Coast Institute for Research, LLC ( Site 0031)
Jacksonville, Florida, United States
Jacksonville Center for Clinical Research ( Site 0048)
Jacksonville, Florida, United States
East Coast Institute for Research ( Site 0034)
Lake City, Florida, United States
Columbus Clinical Services ( Site 0026)
Miami, Florida, United States
Miami Cardiac & Vascular Institute-Ambulatory Research ( Site 0059)
Miami, Florida, United States
Inpatient Research Clinic ( Site 0041)
Miami Lakes, Florida, United States
Eminat ( Site 0082)
Miramar, Florida, United States
Ocala Research Institute - Ocala - Southwest 20th Place ( Site 0079)
Ocala, Florida, United States
Progressive Medical Research ( Site 0045)
Port Orange, Florida, United States
St Johns Center for Clinical Research ( Site 0016)
Saint Augustine, Florida, United States
Clinical Site Partners LLC, dba CSP Orlando ( Site 0067)
Winter Park, Florida, United States
The Jones Center Clinical Research ( Site 0032)
Macon, Georgia, United States
North Georgia Clinical Research ( Site 0128)
Woodstock, Georgia, United States
Bingham Memorial Hospital ( Site 0195)
Blackfoot, Idaho, United States
Synexus Clinical Research US, Inc. ( Site 0084)
Chicago, Illinois, United States
Great Lakes Clinical Trials - Ravenswood ( Site 0056)
Chicago, Illinois, United States
Great Lakes Clinical Trials - Gurnee ( Site 0134)
Gurnee, Illinois, United States
Alliance for Multispecialty Research, LLC ( Site 0173)
Park Ridge, Illinois, United States
Healthcare Research Network - Chicago ( Site 0051)
Tinley Park, Illinois, United States
Alliance for Multispecialty Research - Medisphere Medical Research Center ( Site 0080)
Evansville, Indiana, United States
Parkview Research Center at Parkview Regional Medical Center ( Site 0154)
Fort Wayne, Indiana, United States
Franciscan Physician Network - Indiana Heart Physicians ( Site 0141)
Indianapolis, Indiana, United States
Reid Physician Associates ( Site 0174)
Richmond, Indiana, United States
University of Kansas Medical Center ( Site 0004)
Kansas City, Kansas, United States
Cotton O'Neil Clinical Research Center ( Site 0095)
Topeka, Kansas, United States
AMR Clinical - Wichita ( Site 0116)
Wichita, Kansas, United States
Alliance for Multispecialty Research, LLC ( Site 0027)
Lexington, Kentucky, United States
L-MARC Research Center ( Site 0001)
Louisville, Kentucky, United States
Avant Research Associates ( Site 0103)
Crowley, Louisiana, United States
IMA Clinical Research- Monroe- North 18th Street ( Site 0111)
Monroe, Louisiana, United States
Northeast Cardiology Associates ( Site 0168)
Bangor, Maine, United States
Flourish Research - Bowie ( Site 0190)
Bowie, Maryland, United States
Centennial Medical Group ( Site 0179)
Columbia, Maryland, United States
Brigham and Women's Hospital-Cardiovascular Medicine ( Site 0147)
Boston, Massachusetts, United States
Boston Clinical Trials ( Site 0029)
Boston, Massachusetts, United States
Alliance for Multispecialty Research, LLC. ( Site 0171)
Dearborn, Michigan, United States
Healthy Heart Cardiology ( Site 0113)
Grand Rapids, Michigan, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0003)
Troy, Michigan, United States
Trinity Health-Michigan d/b/a Michigan Heart ( Site 0186)
Ypsilanti, Michigan, United States
Fairview Health Services ( Site 0024)
Maplewood, Minnesota, United States
Abbott Northwestern Hospital ( Site 0199)
Minneapolis, Minnesota, United States
University of Minnesota, Lillehei Clinical Research Unit ( Site 0193)
Minneapolis, Minnesota, United States
Velocity Clinical Research, Gulfport ( Site 0038)
Gulfport, Mississippi, United States
Cardiology Associates of North Mississippi ( Site 0169)
Tupelo, Mississippi, United States
Healthcare Research Network - St. Louis ( Site 0053)
Hazelwood, Missouri, United States
Alliance for Multispecialty Research, LLC ( Site 0071)
Kansas City, Missouri, United States
Skyline Medical Center/CCT Research ( Site 0148)
Elkhorn, Nebraska, United States
Velocity Clinical Research at The Pioneer Heart Institute, Lincoln ( Site 0078)
Lincoln, Nebraska, United States
CHI Health Clinic Heart Institute ( Site 0180)
Lincoln, Nebraska, United States
Excel Clinical Research, LLC ( Site 0123)
Las Vegas, Nevada, United States
Clinical Research of South Nevada ( Site 0135)
Las Vegas, Nevada, United States
Advanced Heart Care - Bridgewater Route 22 ( Site 0160)
Bridgewater, New Jersey, United States
Cardiovascular Associates of the Delaware Valley ( Site 0162)
Washington Township, New Jersey, United States
New Mexico Clinical Research & Osteoporosis Center ( Site 0005)
Albuquerque, New Mexico, United States
Velocity Clinical Research, Binghamton ( Site 0063)
Binghamton, New York, United States
Central New York Clinical Research ( Site 0044)
Manlius, New York, United States
North Shore Diabetes & Endocrine Associates ( Site 0165)
New Hyde Park, New York, United States
Mid Hudson Medical Research ( Site 0087)
New Windsor, New York, United States
NYU Langone Health ( Site 0099)
New York, New York, United States
Rochester Clinical Research, Inc. ( Site 0098)
Rochester, New York, United States
Laurelton Heart Specialist PC ( Site 0092)
Rosedale, New York, United States
Duke University Health System (DUHS) ( Site 0153)
Durham, North Carolina, United States
Wake Forest Baptist Health-Cardiovascular Medicine ( Site 0142)
Winston-Salem, North Carolina, United States
Lillestol Research ( Site 0025)
Fargo, North Dakota, United States
Altru Health System ( Site 0197)
Grand Forks, North Dakota, United States
Velocity Clinical Research, Springdale ( Site 0112)
Cincinnati, Ohio, United States
Cleveland Clinic Main ( Site 0121)
Cleveland, Ohio, United States
The Ohio State Wexner Medical Center ( Site 0200)
Columbus, Ohio, United States
Remington-Davis, Inc. ( Site 0183)
Columbus, Ohio, United States
Premier Cardiovascular Institute ( Site 0136)
Dayton, Ohio, United States
Genesis Healthcare System-Pharmacy Research ( Site 0163)
Zanesville, Ohio, United States
South Oklahoma Heart Research ( Site 0164)
Oklahoma City, Oklahoma, United States