ClinicalTrials.gov record
Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Cardiovascular Outcomes Study (MK-0616-015) CORALreef Outcomes
ClinicalTrials.gov ID: NCT06008756
Public ClinicalTrials.gov record NCT06008756. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06008756
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 14,550 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 9, 2023 (Actual)
- Primary completion
- Nov 29, 2029 (Estimated)
- Completion
- Nov 29, 2031 (Estimated)
- Last update posted
- Apr 23, 2026
2023 – 2031
United States locations
- U.S. sites
- 132
- U.S. states
- 38
- U.S. cities
- 116
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Advanced Cardiovascular - Alexander City ( Site 0156) | Alexander City | Alabama | 35010 | — |
| Central Research Associates ( Site 0118) | Birmingham | Alabama | 35205 | — |
| St. Vincent's Birmingham Hospital ( Site 0181) | Birmingham | Alabama | 35205 | — |
| Central Alabama Research ( Site 0109) | Birmingham | Alabama | 35209 | — |
| Alliance for Multispecialty Research, LLC ( Site 0076) | Daphne | Alabama | 36526 | — |
| G&L Research ( Site 0042) | Foley | Alabama | 36535 | — |
| NextStage Clinical Research - Phoenix - (01) ( Site 0191) | Glendale | Arizona | 85306 | — |
| Synexus Clinical Research US, Inc.-Synexus Clinical Research US, Inc - Central Phoenix ( Site 0066) | Phoenix | Arizona | 85020 | — |
| Medical Investigations Inc. ( Site 0188) | Little Rock | Arkansas | 72211 | — |
| National Heart Institute-Research ( Site 0077) | Beverly Hills | California | 90211 | — |
| UCSD - Altman Clinical and Translational Research Institute (ACTRI) ( Site 0130) | La Jolla | California | 92037 | — |
| Chemidox Clinical Trials ( Site 0145) | Lancaster | California | 93534 | — |
| Velocity Clinical Research, Westlake ( Site 0039) | Los Angeles | California | 90057 | — |
| Carbon Health - Pasadena ( Site 0149) | Pasadena | California | 91101 | — |
| Carbon Health - San Mateo - Hillsdale Mall ( Site 0151) | San Mateo | California | 94403 | — |
| America Clinical Trials-Research Dept ( Site 0104) | Tarzana | California | 91356-3551 | — |
| Premiere Medical Center ( Site 0093) | Toluca Lake | California | 91602 | — |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center ( Site 0058) | Torrance | California | 90502 | — |
| University of Colorado Anschutz Medical Campus-University of Colorado Hospital Cardiac and Vascular ( Site 0146) | Aurora | Colorado | 80045 | — |
| South Denver Cardiology Associates ( Site 0167) | Littleton | Colorado | 80120 | — |
| Cardiology Associates of Fairfield County, P.C. ( Site 0159) | Stamford | Connecticut | 06905 | — |
| Chase Medical Research, LLC ( Site 0046) | Waterbury | Connecticut | 06708 | — |
| Emerson Clinical Research Institute ( Site 0143) | Washington D.C. | District of Columbia | 20009 | — |
| Excel Medical Clinical Trials ( Site 0052) | Boca Raton | Florida | 33434 | — |
| Advanced Pharma Research ( Site 0040) | Cutler Bay | Florida | 33189 | — |
| Alliance for Multispecialty Research, LLC ( Site 0083) | Fort Myers | Florida | 33912 | — |
| Westside Center for Clinical Research ( Site 0049) | Jacksonville | Florida | 32205 | — |
| University of Florida - Jacksonville ( Site 0166) | Jacksonville | Florida | 32209 | — |
| East Coast Institute for Research, LLC ( Site 0031) | Jacksonville | Florida | 32216 | — |
| Jacksonville Center for Clinical Research ( Site 0048) | Jacksonville | Florida | 32216 | — |
| East Coast Institute for Research ( Site 0034) | Lake City | Florida | 32055 | — |
| Columbus Clinical Services ( Site 0026) | Miami | Florida | 33125 | — |
| Miami Cardiac & Vascular Institute-Ambulatory Research ( Site 0059) | Miami | Florida | 33173 | — |
| Inpatient Research Clinic ( Site 0041) | Miami Lakes | Florida | 33014 | — |
| Eminat ( Site 0082) | Miramar | Florida | 33027 | — |
| Ocala Research Institute - Ocala - Southwest 20th Place ( Site 0079) | Ocala | Florida | 34471 | — |
| Progressive Medical Research ( Site 0045) | Port Orange | Florida | 32127 | — |
| St Johns Center for Clinical Research ( Site 0016) | Saint Augustine | Florida | 32086 | — |
| Clinical Site Partners LLC, dba CSP Orlando ( Site 0067) | Winter Park | Florida | 32789 | — |
| The Jones Center Clinical Research ( Site 0032) | Macon | Georgia | 31210 | — |
| North Georgia Clinical Research ( Site 0128) | Woodstock | Georgia | 30189 | — |
| Bingham Memorial Hospital ( Site 0195) | Blackfoot | Idaho | 83221 | — |
| Synexus Clinical Research US, Inc. ( Site 0084) | Chicago | Illinois | 60602 | — |
| Great Lakes Clinical Trials - Ravenswood ( Site 0056) | Chicago | Illinois | 60640 | — |
| Great Lakes Clinical Trials - Gurnee ( Site 0134) | Gurnee | Illinois | 60031 | — |
| Alliance for Multispecialty Research, LLC ( Site 0173) | Park Ridge | Illinois | 60068 | — |
| Healthcare Research Network - Chicago ( Site 0051) | Tinley Park | Illinois | 60477 | — |
| Alliance for Multispecialty Research - Medisphere Medical Research Center ( Site 0080) | Evansville | Indiana | 47714 | — |
| Parkview Research Center at Parkview Regional Medical Center ( Site 0154) | Fort Wayne | Indiana | 46845 | — |
| Franciscan Physician Network - Indiana Heart Physicians ( Site 0141) | Indianapolis | Indiana | 46237 | — |
| Reid Physician Associates ( Site 0174) | Richmond | Indiana | 47374 | — |
| University of Kansas Medical Center ( Site 0004) | Kansas City | Kansas | 66160 | — |
| Cotton O'Neil Clinical Research Center ( Site 0095) | Topeka | Kansas | 66606 | — |
| AMR Clinical - Wichita ( Site 0116) | Wichita | Kansas | 67226 | — |
| Alliance for Multispecialty Research, LLC ( Site 0027) | Lexington | Kentucky | 40509 | — |
| L-MARC Research Center ( Site 0001) | Louisville | Kentucky | 40213 | — |
| Avant Research Associates ( Site 0103) | Crowley | Louisiana | 70526 | — |
| IMA Clinical Research- Monroe- North 18th Street ( Site 0111) | Monroe | Louisiana | 71201 | — |
| Northeast Cardiology Associates ( Site 0168) | Bangor | Maine | 04401 | — |
| Flourish Research - Bowie ( Site 0190) | Bowie | Maryland | 20715 | — |
| Centennial Medical Group ( Site 0179) | Columbia | Maryland | 21045 | — |
| Brigham and Women's Hospital-Cardiovascular Medicine ( Site 0147) | Boston | Massachusetts | 02115 | — |
| Boston Clinical Trials ( Site 0029) | Boston | Massachusetts | 02131 | — |
| Alliance for Multispecialty Research, LLC. ( Site 0171) | Dearborn | Michigan | 48126 | — |
| Healthy Heart Cardiology ( Site 0113) | Grand Rapids | Michigan | 49546 | — |
| Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0003) | Troy | Michigan | 48098 | — |
| Trinity Health-Michigan d/b/a Michigan Heart ( Site 0186) | Ypsilanti | Michigan | 48197 | — |
| Fairview Health Services ( Site 0024) | Maplewood | Minnesota | 55109 | — |
| Abbott Northwestern Hospital ( Site 0199) | Minneapolis | Minnesota | 55407 | — |
| University of Minnesota, Lillehei Clinical Research Unit ( Site 0193) | Minneapolis | Minnesota | 55455 | — |
| Velocity Clinical Research, Gulfport ( Site 0038) | Gulfport | Mississippi | 39503 | — |
| Cardiology Associates of North Mississippi ( Site 0169) | Tupelo | Mississippi | 38801 | — |
| Healthcare Research Network - St. Louis ( Site 0053) | Hazelwood | Missouri | 63042 | — |
| Alliance for Multispecialty Research, LLC ( Site 0071) | Kansas City | Missouri | 64114 | — |
| Skyline Medical Center/CCT Research ( Site 0148) | Elkhorn | Nebraska | 68022 | — |
| Velocity Clinical Research at The Pioneer Heart Institute, Lincoln ( Site 0078) | Lincoln | Nebraska | 68510 | — |
| CHI Health Clinic Heart Institute ( Site 0180) | Lincoln | Nebraska | 68526 | — |
| Excel Clinical Research, LLC ( Site 0123) | Las Vegas | Nevada | 89109 | — |
| Clinical Research of South Nevada ( Site 0135) | Las Vegas | Nevada | 89121-4350 | — |
| Advanced Heart Care - Bridgewater Route 22 ( Site 0160) | Bridgewater | New Jersey | 08807 | — |
| Cardiovascular Associates of the Delaware Valley ( Site 0162) | Washington Township | New Jersey | 08080 | — |
| New Mexico Clinical Research & Osteoporosis Center ( Site 0005) | Albuquerque | New Mexico | 87106 | — |
| Velocity Clinical Research, Binghamton ( Site 0063) | Binghamton | New York | 13905 | — |
| Central New York Clinical Research ( Site 0044) | Manlius | New York | 13104 | — |
| North Shore Diabetes & Endocrine Associates ( Site 0165) | New Hyde Park | New York | 11042 | — |
| Mid Hudson Medical Research ( Site 0087) | New Windsor | New York | 12553 | — |
| NYU Langone Health ( Site 0099) | New York | New York | 10016 | — |
| Rochester Clinical Research, Inc. ( Site 0098) | Rochester | New York | 14609 | — |
| Laurelton Heart Specialist PC ( Site 0092) | Rosedale | New York | 11422 | — |
| Duke University Health System (DUHS) ( Site 0153) | Durham | North Carolina | 27710 | — |
| Wake Forest Baptist Health-Cardiovascular Medicine ( Site 0142) | Winston-Salem | North Carolina | 27157 | — |
| Lillestol Research ( Site 0025) | Fargo | North Dakota | 58104 | — |
| Altru Health System ( Site 0197) | Grand Forks | North Dakota | 58201 | — |
| Velocity Clinical Research, Springdale ( Site 0112) | Cincinnati | Ohio | 45246 | — |
| Cleveland Clinic Main ( Site 0121) | Cleveland | Ohio | 44195 | — |
| The Ohio State Wexner Medical Center ( Site 0200) | Columbus | Ohio | 43203 | — |
| Remington-Davis, Inc. ( Site 0183) | Columbus | Ohio | 43215 | — |
| Premier Cardiovascular Institute ( Site 0136) | Dayton | Ohio | 45414 | — |
| Genesis Healthcare System-Pharmacy Research ( Site 0163) | Zanesville | Ohio | 43701 | — |
| South Oklahoma Heart Research ( Site 0164) | Oklahoma City | Oklahoma | 73135 | — |
| Capital Area Research, LLC ( Site 0139) | Camp Hill | Pennsylvania | 17011 | — |
| Guthrie Medical Group, P.C. ( Site 0176) | Sayre | Pennsylvania | 18840 | — |
| Cardiology Consultants of Philadelphia Yardley ( Site 0072) | Yardley | Pennsylvania | 19067 | — |
| Velocity Clinical Research, Anderson ( Site 0022) | Anderson | South Carolina | 29621 | — |
| Coastal Carolina Research Center ( Site 0006) | North Charleston | South Carolina | 29405 | — |
| Monument Health Clinical Research, a department of Monument -Monument Health Clinical Research, a d ( Site 0009) | Rapid City | South Dakota | 57701 | — |
| Holston Medical Group ( Site 0106) | Bristol | Tennessee | 37620 | — |
| Holston Medical Group ( Site 0047) | Kingsport | Tennessee | 37660 | — |
| Alliance for Multispecialty Research, LLC ( Site 0008) | Knoxville | Tennessee | 37909 | — |
| PharmaTex Research, LLC ( Site 0182) | Amarillo | Texas | 79106 | — |
| Texas Diabetes and Endocrinology, P.A. ( Site 0187) | Austin | Texas | 78731 | — |
| Southwest Family Medicine Associates ( Site 0189) | Dallas | Texas | 75235 | — |
| Prolato Clinical Research Center ( Site 0108) | Houston | Texas | 77054 | — |
| Permian Research Foundation ( Site 0157) | Odessa | Texas | 79761 | — |
| LinQ Research ( Site 0101) | Pearland | Texas | 77584 | — |
| Northeast Clinical Research of San Antonio ( Site 0011) | San Antonio | Texas | 78233 | — |
| Discovery Clinical Trials ( Site 0096) | San Antonio | Texas | 78258 | — |
| Sugar Lakes Family Practice, PA ( Site 0094) | Sugar Land | Texas | 77479 | — |
| LinQ Research - Tomball ( Site 0208) | Tomball | Texas | 77375 | — |
| Northwest Houston Heart Center-Northwest Houston Clinical Research, PLLC ( Site 0158) | Tomball | Texas | 77375 | — |
| NextStage Clinical Research - Waco ( Site 0196) | Waco | Texas | 76712 | — |
| Synexus Clinical Research US, Inc. ( Site 0086) | Salt Lake City | Utah | 84106 | — |
| Highland Clinical Research ( Site 0122) | Salt Lake City | Utah | 84124 | — |
| Velocity Clinical Research, Salt Lake City ( Site 0019) | West Jordan | Utah | 84088 | — |
| Burke Internal Medicine and Research ( Site 0035) | Burke | Virginia | 22015 | — |
| Charlottesville Medical Research ( Site 0030) | Charlottesville | Virginia | 22911 | — |
| Virginia Heart ( Site 0097) | Falls Church | Virginia | 22042 | — |
| Carient Heart & Vascular - Manassas ( Site 0170) | Manassas | Virginia | 20109 | — |
| Manassas Clinical Research Center ( Site 0007) | Manassas | Virginia | 20110 | — |
| Health Research of Hampton Roads, Inc. ( Site 0043) | Newport News | Virginia | 23606 | — |
| Alliance for Multispecialty Research, LLC ( Site 0068) | Norfolk | Virginia | 23502 | — |
| Centricity Research Suffolk Family Medicine ( Site 0105) | Suffolk | Virginia | 23435 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 537 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06008756, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 23, 2026 · Synced Oct 31, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06008756 live on ClinicalTrials.gov.