A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-013) CORALreef Lipids
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-0616 in Adults With Hypercholesterolemia
5 other identifiers
interventional
2,912
14 countries
168
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2023
168 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2023
CompletedFirst Posted
Study publicly available on registry
July 19, 2023
CompletedStudy Start
First participant enrolled
August 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 28, 2025
CompletedSeptember 10, 2025
September 1, 2025
2 years
July 10, 2023
September 8, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24
Blood samples will be collected at baseline and at Week 24 to assess mean percent change in LDL-C.
Baseline and Week 24
Number of participants with one or more adverse events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Up to ~60 weeks
Number of participants who discontinue study drug due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Up to ~52 weeks
Secondary Outcomes (6)
Mean percent change from baseline in LDL-C at Week 52
Baseline and Week 52
Mean percent change from baseline in non-high-density lipoprotein cholesterol (non-HDL-C) at Week 24
Baseline and Week 24
Mean percent change from baseline in apolipoprotein B (ApoB) at Week 24
Baseline and Week 24
Percent change from baseline in lipoprotein(a) (Lp[a]) at Week 24
Baseline and Week 24
Percentage of participants with LDL-C <70 mg/dL and ≥50% reduction from baseline at Week 24
Baseline and Week 24
- +1 more secondary outcomes
Study Arms (2)
Enlicitide Decanoate
EXPERIMENTALParticipants will receive 20 mg of enlicitide decanoate orally once daily (QD) for up to 52 weeks.
Placebo
PLACEBO COMPARATORParticipants will receive enlicitide decanoate-matching placebo orally QD for up to 52 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Has a history of a major atherosclerotic cardiovascular disease (ASCVD) event and LDL-C ≥55 mg/dL OR, if no history of a major ASCVD event, has intermediate to high risk for development of a first major ASCVD event and LDL-C ≥70 mg/dL.
- Is treated with a moderate- or high-intensity statin OR is treated with low-intensity statin with documentation of intolerance to a moderate or high-intensity statin OR is not receiving statins with documentation of statin intolerance
- If on any lipid-lowering therapies (LLTs), should be on a stable dose with no planned medication change.
You may not qualify if:
- Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria, compound heterozygous FH, or double heterozygous FH
- 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 without adequate washout
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (168)
Alliance for Multispecialty Research, LLC ( Site 0093)
Daphne, Alabama, 36526, United States
G&L Research ( Site 0043)
Foley, Alabama, 36535, United States
Synexus Clinical Research US, Inc.-Synexus Clinical Research US, Inc - Central Phoenix ( Site 0084)
Phoenix, Arizona, 85020, United States
National Heart Institute-Research ( Site 0087)
Beverly Hills, California, 90211, United States
Clinical Trials Research ( Site 0115)
Sacramento, California, 95821, United States
Velocity Clinical Research, Banning ( Site 0017)
San Bernardino, California, 92408, United States
Emerson Clinical Research Institute ( Site 0118)
Washington D.C., District of Columbia, 20009, United States
Excel Medical Clinical Trials ( Site 0053)
Boca Raton, Florida, 33434, United States
Alliance for Multispecialty Research, LLC ( Site 0088)
Coral Gables, Florida, 33134, United States
Alliance for Multispecialty Research, LLC ( Site 0094)
Fort Myers, Florida, 33912, United States
Velocity Clinical Research, Hallandale Beach ( Site 0018)
Hallandale, Florida, 33009, United States
Jacksonville Center for Clinical Research ( Site 0049)
Jacksonville, Florida, 32216, United States
South Broward Research ( Site 0051)
Miramar, Florida, 33027, United States
Clinical Research Trials of Florida ( Site 0063)
Tampa, Florida, 33607, United States
East Coast Institute for Research, LLC ( Site 0033)
Macon, Georgia, 31210, United States
Healthcare Research Network - Chicago ( Site 0052)
Flossmoor, Illinois, 60422, United States
Synexus Clinical Research US, Inc. ( Site 0109)
Evansville, Indiana, 47714, United States
Midwest Institute For Clinical Research ( Site 0059)
Indianapolis, Indiana, 46260, United States
Alliance for Multispecialty Research, LLC ( Site 0028)
Lexington, Kentucky, 40509, United States
L-MARC Research Center ( Site 0001)
Louisville, Kentucky, 40213, United States
Velocity Clinical Research, Covington ( Site 0068)
Covington, Louisiana, 70433, United States
Velocity Clinical Research Rockville ( Site 0082)
Rockville, Maryland, 20854, United States
Velocity Clinical Research, Gulfport ( Site 0039)
Gulfport, Mississippi, 39503, United States
Healthcare Research Network - St. Louis ( Site 0054)
Hazelwood, Missouri, 63042, United States
Jubilee Clinical Research ( Site 0106)
Las Vegas, Nevada, 89106, United States
AB Clinical Trials ( Site 0070)
Las Vegas, Nevada, 89119, United States
New Mexico Clinical Research & Osteoporosis Center ( Site 0005)
Albuquerque, New Mexico, 87106, United States
Velocity Clinical Research, Syracuse ( Site 0021)
East Syracuse, New York, 13057, United States
Icahn School of Medicine at Mount Sinai-Cardiology ( Site 0002)
New York, New York, 10029, United States
Lillestol Research ( Site 0026)
Fargo, North Dakota, 58104, United States
altoona center for clinical research ( Site 0089)
Duncansville, Pennsylvania, 16635, United States
Cardiology Consultants of Philadelphia Yardley ( Site 0097)
Yardley, Pennsylvania, 19067, United States
Piedmont Research Partners ( Site 0090)
Fort Mill, South Carolina, 29707, United States
Velocity Clinical Research, Greenville ( Site 0023)
Greenville, South Carolina, 29615, United States
Coastal Carolina Research Center ( Site 0006)
North Charleston, South Carolina, 29405, United States
Monument Health Clinical Research, a department of Monument -Monument Health Clinical Research, a d ( Site 0009)
Rapid City, South Dakota, 57701, United States
Holston Medical Group ( Site 0048)
Kingsport, Tennessee, 37660, United States
Alliance for Multispecialty Research, LLC ( Site 0008)
Knoxville, Tennessee, 37920, United States
Velocity Clinical Research, Dallas ( Site 0114)
Dallas, Texas, 75230, United States
Center for Cardiometabolic Disease Prevention/Baylor College of Medicine ( Site 0111)
Houston, Texas, 77030, United States
Clinical Trials of Texas, LLC ( Site 0103)
San Antonio, Texas, 78229, United States
Synexus Clinical Research US, Inc. ( Site 0110)
Salt Lake City, Utah, 84106, United States
Velocity Clinical Research, Salt Lake City ( Site 0019)
West Jordan, Utah, 84088, United States
Manassas Clinical Research Center ( Site 0007)
Manassas, Virginia, 20110, United States
Health Research of Hampton Roads, Inc. ( Site 0044)
Newport News, Virginia, 23606, United States
Alliance for Multispecialty Research, LLC ( Site 0101)
Norfolk, Virginia, 23502, United States
National Clinical Research, Inc ( Site 0061)
Richmond, Virginia, 23294, United States
Centricity Research Suffolk Family Medicine ( Site 0092)
Suffolk, Virginia, 23435, United States
Rainier Clinical Research Center ( Site 0116)
Renton, Washington, 98057, United States
CEDIC ( Site 0612)
CABA, Buenos Aires, C1060ABN, Argentina
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0605)
Mar del Plata, Buenos Aires, B7600FZO, Argentina
Instituto de Investigaciones Clinicas Zarate ( Site 0600)
Zárate, Buenos Aires, B2800DGH, Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0604)
Buenos Aires, Buenos Aires F.D., C1425AGC, Argentina
Fundación Respirar ( Site 0610)
Buenos Aires, Buenos Aires F.D., C1426ABP, Argentina
Centro de Investigaciones Metabólicas (CINME)-Cardiology ( Site 0620)
CABA, C1056ABI, Argentina
Beijing Anzhen Hospital, Capital Medical University-Cardiovascular ( Site 3300)
Beijing, Beijing Municipality, 100029, China
Beijing Friendship Hospital Affiliate of Capital University-Cardiology ( Site 3303)
Beijing, Beijing Municipality, 100050, China
The Second Affiliated Hospital of Chongqing Medical University ( Site 3320)
Chongqing, Chongqing Municipality, 400072, China
Chongqing University Three Gorges Hospital ( Site 3321)
Chongqing, Chongqing Municipality, 404000, China
Guangdong Provincial People's Hospital-Cardiology ( Site 3304)
Guangzhou, Guangdong, 510080, China
Zhujiang Hospital of Southern Medical University ( Site 3329)
Guangzhou, Guangdong, 510280, China
Huizhou Municipal Central Hospital ( Site 3379)
Huizhou, Guangdong, 516001, China
The University of Hong Kong-Shenzhen Hospital-Cardiovascular department ( Site 3318)
Shenzhen, Guangdong, 518053, China
Jingzhou Central Hospital-Cardiology ( Site 3376)
Jingzhou, Hubei, 434036, China
Wuhan Fourth Hospital ( Site 3356)
Wuhan, Hubei, 430030, China
Hunan Provincial People's Hospital-Cardiology ( Site 3317)
Changsha, Hunan, 410005, China
Changzhou Second People's Hospital-Cardiology ( Site 3373)
Changzhou, Jiangsu, 213000, China
Northern Jiangsu People's Hospital ( Site 3308)
Yangzhou, Jiangsu, 225001, China
The Third Hospital of Nanchang - Fuhe-cardiology ( Site 3378)
Nanchang, Jiangxi, 330003, China
Siping Central People's Hospital-Cardiovascular Department ( Site 3311)
Siping, Jilin, 136000, China
Xianyang Hospital of Yan'an University ( Site 3340)
Xianyang, Shaanxi, 712000, China
Chengdu Second Municipal People's Hospital ( Site 3332)
Chengdu, Sichuan, 610021, China
People's Hospital of Lishui City-department of cardiovascular ( Site 3302)
Lishui, Zhejiang, 323000, China
Fundación Centro de Investigación Clínica CIC ( Site 0906)
Medellín, Antioquia, 050021, Colombia
Ciensalud Ips S A S ( Site 0903)
Barranquilla, Atlántico, 08001, Colombia
Clinica de la Costa S.A.S. ( Site 0902)
Barranquilla, Atlántico, 080020, Colombia
Salud SURA Calle 100 ( Site 0918)
Bogotá, Cundinamarca, 110231, Colombia
Healthy Medical Center S.A.S ( Site 0913)
Zipaquirá, Cundinamarca, 250252, Colombia
Fundación Valle del Lili ( Site 0904)
Cali, Valle del Cauca Department, 760032, Colombia
Unterfrintroper Hausarztzentrum Klinische Forschung ( Site 1542)
Essen, North Rhine-Westphalia, 45359, Germany
Universitaetsklinikum Carl Gustav Carus Dresden-Universitätsstudienzentrum für Stoffwechselerkranku ( Site 1508)
Dresden, Saxony, 01307, Germany
Hausarzt- und Diabetologische Schwerpunktpraxis Hohenmölsen - Weiβenfels ( Site 1527)
Hohenmölsen, Saxony-Anhalt, 06679, Germany
Zentralklinik Bad Berka ( Site 1530)
Bad Berka, Thuringia, 99437, Germany
Velocity Clinical Research GmbH Berlin ( Site 1502)
Berlin, 10787, Germany
Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 1533)
Berlin, 12203, Germany
Hillel Yaffe Medical Center ( Site 1705)
Hadera, 3810101, Israel
Rambam Health Care Campus-internal department ( Site 1718)
Haifa, 3109601, Israel
Shaare Zedek Medical Center ( Site 1710)
Jerusalem, 9103102, Israel
Hadassah Medical Center ( Site 1706)
Jerusalem, 9112001, Israel
Hadassah Medical Center ( Site 1709)
Jerusalem, 9112001, Israel
Meir Medical Center. ( Site 1714)
Kfar Saba, 4428164, Israel
Rabin Medical Center ( Site 1720)
Petah Tikva, 4941 492, Israel
Sheba Medical Center ( Site 1708)
Ramat Gan, 5265601, Israel
Yitzhak Shamir Medical Center. ( Site 1712)
Ẕerifin, 7033001, Israel
Fondazione Policlinico Tor Vergata ( Site 1809)
Rome, Lazio, 00133, Italy
Centro Cardiologico Monzino ( Site 1804)
Milan, Milano, 20138, Italy
ASST Grande Ospedale Metropolitano Niguarda-Unità Ricerche Cliniche della Cardiologia 4 ( Site 1811)
Milan, Milano, 20162, Italy
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino ( Site 1801)
Turin, Piedmont, 10126, Italy
Azienda Ospedaliera Sant'Andrea-Department of Clinical and Molecular Medicine ( Site 1807)
Rome, Roma, 00189, Italy
Azienda Ospedaliera Garibaldi ( Site 1810)
Catania, 95122, Italy
Hirohata Naika Clinic ( Site 3513)
Kitakyusyu-shi, Fukuoka, 807-0857, Japan
Nakakinen clinic ( Site 3510)
Naka, Ibaraki, 311-0113, Japan
Noritake Clinic ( Site 3512)
Ushiku, Ibaraki, 300-1207, Japan
National Hospital Organization Kanazawa Medical Center ( Site 3508)
Kanazawa, Ishikawa-ken, 920-8650, Japan
Hirano Medical Clinic ( Site 3522)
Morioka, Iwate, 020-0132, Japan
Shirai Healthcare Clinic Izumichuou ( Site 3527)
Sendai, Miyagi, 981-3133, Japan
Rinku General Medical Center ( Site 3503)
Izumisano, Osaka, 598-8577, Japan
Shiraiwa Medical Clinic ( Site 3514)
Kashihara, Osaka, 582-0005, Japan
Medical Corporation Heishinkai OCROM Clinic ( Site 3501)
Suita-shi, Osaka, 565-0853, Japan
Saitama Medical University Hospital ( Site 3506)
Iruma, Saitama, 350-0495, Japan
Teramoto Medical and Dental Clinic ( Site 3507)
Bunkyo-ku, Tokyo, 113-0033, Japan
Tokyo-Eki Center-building Clinic ( Site 3505)
Chuo-ku, Tokyo, 103-0027, Japan
Fukuwa Clinic ( Site 3504)
Chuo-ku, Tokyo, 104-0031, Japan
Teikyo University Hospital ( Site 3500)
Itabashi-ku, Tokyo, 173-8606, Japan
Kato Clinic of Internal Medicine ( Site 3509)
Katsushika-ku, Tokyo, 125-0054, Japan
Kanno Naika ( Site 3511)
Mitaka, Tokyo, 181-0013, Japan
Sugawara Clinic ( Site 3519)
Nerima-ku, Tokyo, 177-0041, Japan
Shin Clinic ( Site 3517)
Ōta-ku, Tokyo, 144-0051, Japan
Medical Corporation Heishinkai ToCROM Clinic ( Site 3502)
Shinjuku-ku, Tokyo, 160-0008, Japan
Mitsukoshi Health and Welfare Foundation ( Site 3521)
Shinjuku-ku, Tokyo, 160-0023, Japan
Medical Corporation Hakuaikai Wellness Tenjin Clinic ( Site 3520)
Fukuoka, 810-0001, Japan
Hiroshima City Hiroshima Citizens Hospital ( Site 3518)
Hiroshima, 730-8518, Japan
Mishuku Hospital ( Site 3524)
Tokyo, 153-0051, Japan
Instituto Jalisciense de Investigacion en Diabetes y Obesidad-Endocrinology ( Site 1057)
Guadalajara, Jalisco, 44600, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 1071)
Mexico City, Mexico City, 14080, Mexico
IATROS INTERNATIONAL ( Site 2247)
Bloemfontein, Free State, 9301, South Africa
Soweto Clinical Trials Centre ( Site 2242)
Johannesburg, Gauteng, 1818, South Africa
Charlotte Maxeke Johannesburg Academic Hospital-WCR-LIPIDS ( Site 2241)
Johannesburg, Gauteng, 2193, South Africa
Tiervlei Trial Centre-Clinical ( Site 2246)
Bellville, Cape Town, Western Cape, 7530, South Africa
TREAD Research ( Site 2253)
Cape Town, Western Cape, 7500, South Africa
University of Cape Town (UCT)-Medicine, Division of Lipidology ( Site 2259)
Cape Town, Western Cape, 7925, South Africa
Wonju Severance Christian Hospital ( Site 3008)
Wŏnju, Kang-won-do, 26426, South Korea
Chonnam National University Hospital ( Site 3014)
Gwangju, Kwangju-Kwangyokshi, 61469, South Korea
Seoul National University Bundang Hospital ( Site 3005)
Seongnam, Kyonggi-do, 13620, South Korea
Ajou University Hospital ( Site 3006)
Suwon, Kyonggi-do, 16499, South Korea
Chungbuk National University Hospital ( Site 3011)
Cheongju-si, North Chungcheong, 28644, South Korea
Dong-A University Hospital ( Site 3013)
Busan, Pusan-Kwangyokshi, 49201, South Korea
Pusan National University Hospital-Internal Medicine ( Site 3012)
Busan, Pusan-Kwangyokshi, 49241, South Korea
Inje University Haeundae Paik Hospital ( Site 3010)
Haeundae-gu, Pusan-Kwangyokshi, 48108, South Korea
Keimyung University Dongsan Hospital CRC room 1 ( Site 3003)
Daegu, Taegu-Kwangyokshi, 42601, South Korea
Seoul National University Hospital ( Site 3001)
Seoul, 03080, South Korea
Kangbuk Samsung Hospital ( Site 3009)
Seoul, 03181, South Korea
Severance Hospital, Yonsei University Health System ( Site 3002)
Seoul, 03722, South Korea
Asan Medical Center ( Site 3004)
Seoul, 05505, South Korea
Samsung Medical Center-cardiology ( Site 3000)
Seoul, 06351, South Korea
The Catholic Univ. of Korea Seoul St. Mary's Hospital-cardiology ( Site 3007)
Seoul, 06591, South Korea
Hospital Universitario Virgen Macarena ( Site 2352)
Seville, Andalusia, 41009, Spain
EBA CENTELLES ( Site 2311)
Centelles, Catalonia, 08500, Spain
Hospital Abente y Lago ( Site 2356)
A Coruña, La Coruna, 15001, Spain
CHUS - Hospital Clinico Universitario-Cardiology - Clinical Research Unit ( Site 2320)
Santiago de Compostela, La Coruna, 15706, Spain
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-Endocrinologia y Nutrición ( Site 2344)
Pozuelo de Alarcón, Madrid, 28223, Spain
Hospital Universitario Fundacion ALcorcon-Endocrinologia y Nutrición ( Site 2316)
Alcorcón, Madrid, Comunidad de, 28922, Spain
Vithas Hospital Sevilla-Unidad de Salud Metabólica. Diabetes y Obesidad ( Site 2349)
Castilleja de la Cuesta, Sevilla, 41950, Spain
HOSPITAL CLINICO DE VALENCIA-CARDIOLOGY ( Site 2321)
Valencia, Valenciana, Comunitat, 46010, Spain
Hospital Universitario 12 de Octubre-Internal Medicine. Unidad de Ensayos Clínicos ( Site 2319)
Madrid, 28041, Spain
Chi Mei Medical Center-Cardiology ( Site 3104)
Tainan, Tainan, 71004, Taiwan
Changhua Christian Hospital ( Site 3101)
Changhua, 50006, Taiwan
Chang Gung Memorial Hospital at Kaohsiung ( Site 3102)
Kaohsiung City, 83301, Taiwan
National Cheng Kung University Hospital ( Site 3107)
Tainan, 704, Taiwan
National Taiwan University Hospital ( Site 3100)
Taipei, 10002, Taiwan
Taipei Medical University Hospital-Cardiology ( Site 3108)
Taipei, 110, Taiwan
Taipei Veterans General Hospital ( Site 3106)
Taipei, 112, Taiwan
Hacettepe Universite Hastaneleri ( Site 2500)
Altindağ, Ankara, 06230, Turkey (Türkiye)
Ege Universitesi Hastanesi-Cardilogy Department ( Site 2502)
Bornova, İzmir, 35100, Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi-cardiology ( Site 2501)
Ankara, 06800, Turkey (Türkiye)
Eskisehir Osmangazi University-Cardiology ( Site 2510)
Eskişehir, 26480, Turkey (Türkiye)
Erciyes Universitesi Tıp Fakultesi Hastaneleri-endocrine ( Site 2522)
Kayseri, 380280, Turkey (Türkiye)
Kocaeli Üniversitesi-Cardiology ( Site 2516)
Kocaeli, 41380, Turkey (Türkiye)
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2023
First Posted
July 19, 2023
Study Start
August 10, 2023
Primary Completion
July 28, 2025
Study Completion
July 28, 2025
Last Updated
September 10, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf