A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-013) CORALreef Lipids
NCT ID: NCT05952856
Last Updated: 2025-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
2912 participants
INTERVENTIONAL
2023-08-10
2025-07-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Enlicitide Decanoate
Participants will receive 20 mg of enlicitide decanoate orally once daily (QD) for up to 52 weeks.
Enlicitide Decanoate
Oral tablet
Placebo
Participants will receive enlicitide decanoate-matching placebo orally QD for up to 52 weeks.
Placebo
Oral tablet
Interventions
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Enlicitide Decanoate
Oral tablet
Placebo
Oral tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Sheba Medical Center ( Site 1708)
Ramat Gan, , 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
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
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
Hirohata Naika Clinic ( Site 3513)
Kitakyusyu-shi, Fukuoka, Japan
Nakakinen clinic ( Site 3510)
Naka, Ibaraki, Japan
Noritake Clinic ( Site 3512)
Ushiku, Ibaraki, Japan
National Hospital Organization Kanazawa Medical Center ( Site 3508)
Kanazawa, Ishikawa-ken, Japan
Hirano Medical Clinic ( Site 3522)
Morioka, Iwate, Japan
Shirai Healthcare Clinic Izumichuou ( Site 3527)
Sendai, Miyagi, Japan
Rinku General Medical Center ( Site 3503)
Izumisano, Osaka, Japan
Shiraiwa Medical Clinic ( Site 3514)
Kashihara, Osaka, Japan
Medical Corporation Heishinkai OCROM Clinic ( Site 3501)
Suita-shi, Osaka, Japan
Saitama Medical University Hospital ( Site 3506)
Iruma, Saitama, Japan
Teramoto Medical and Dental Clinic ( Site 3507)
Bunkyo-ku, Tokyo, Japan
Tokyo-Eki Center-building Clinic ( Site 3505)
Chuo-ku, Tokyo, Japan
Fukuwa Clinic ( Site 3504)
Chuo-ku, Tokyo, Japan
Teikyo University Hospital ( Site 3500)
Itabashi-ku, Tokyo, Japan
Kato Clinic of Internal Medicine ( Site 3509)
Katsushika-ku, Tokyo, Japan
Kanno Naika ( Site 3511)
Mitaka, Tokyo, Japan
Sugawara Clinic ( Site 3519)
Nerima-ku, Tokyo, Japan
Shin Clinic ( Site 3517)
Ōta-ku, Tokyo, Japan
Medical Corporation Heishinkai ToCROM Clinic ( Site 3502)
Shinjuku-ku, Tokyo, Japan
Mitsukoshi Health and Welfare Foundation ( Site 3521)
Shinjuku-ku, Tokyo, Japan
Medical Corporation Hakuaikai Wellness Tenjin Clinic ( Site 3520)
Fukuoka, , Japan
Hiroshima City Hiroshima Citizens Hospital ( Site 3518)
Hiroshima, , Japan
Mishuku Hospital ( Site 3524)
Tokyo, , Japan
Instituto Jalisciense de Investigacion en Diabetes y Obesidad-Endocrinology ( Site 1057)
Guadalajara, Jalisco, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 1071)
Mexico City, Mexico City, Mexico
IATROS INTERNATIONAL ( Site 2247)
Bloemfontein, Free State, South Africa
Soweto Clinical Trials Centre ( Site 2242)
Johannesburg, Gauteng, South Africa
Charlotte Maxeke Johannesburg Academic Hospital-WCR-LIPIDS ( Site 2241)
Johannesburg, Gauteng, South Africa
Tiervlei Trial Centre-Clinical ( Site 2246)
Bellville, Cape Town, Western Cape, South Africa
TREAD Research ( Site 2253)
Cape Town, Western Cape, South Africa
University of Cape Town (UCT)-Medicine, Division of Lipidology ( Site 2259)
Cape Town, Western Cape, South Africa
Wonju Severance Christian Hospital ( Site 3008)
Wŏnju, Kang-won-do, South Korea
Chonnam National University Hospital ( Site 3014)
Gwangju, Kwangju-Kwangyokshi, South Korea
Seoul National University Bundang Hospital ( Site 3005)
Seongnam, Kyonggi-do, South Korea
Ajou University Hospital ( Site 3006)
Suwon, Kyonggi-do, South Korea
Chungbuk National University Hospital ( Site 3011)
Cheongju-si, North Chungcheong, South Korea
Dong-A University Hospital ( Site 3013)
Busan, Pusan-Kwangyokshi, South Korea
Pusan National University Hospital-Internal Medicine ( Site 3012)
Busan, Pusan-Kwangyokshi, South Korea
Inje University Haeundae Paik Hospital ( Site 3010)
Haeundae-gu, Pusan-Kwangyokshi, South Korea
Keimyung University Dongsan Hospital CRC room 1 ( Site 3003)
Daegu, Taegu-Kwangyokshi, South Korea
Seoul National University Hospital ( Site 3001)
Seoul, , South Korea
Kangbuk Samsung Hospital ( Site 3009)
Seoul, , South Korea
Severance Hospital, Yonsei University Health System ( Site 3002)
Seoul, , South Korea
Asan Medical Center ( Site 3004)
Seoul, , South Korea
Samsung Medical Center-cardiology ( Site 3000)
Seoul, , South Korea
The Catholic Univ. of Korea Seoul St. Mary's Hospital-cardiology ( Site 3007)
Seoul, , South Korea
Hospital Universitario Virgen Macarena ( Site 2352)
Seville, Andalusia, Spain
EBA CENTELLES ( Site 2311)
Centelles, Catalonia, Spain
Hospital Abente y Lago ( Site 2356)
A Coruña, La Coruna, Spain
CHUS - Hospital Clinico Universitario-Cardiology - Clinical Research Unit ( Site 2320)
Santiago de Compostela, La Coruna, Spain
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-Endocrinologia y Nutrición ( Site 2344)
Pozuelo de Alarcón, Madrid, Spain
Hospital Universitario Fundacion ALcorcon-Endocrinologia y Nutrición ( Site 2316)
Alcorcón, Madrid, Comunidad de, Spain
Vithas Hospital Sevilla-Unidad de Salud Metabólica. Diabetes y Obesidad ( Site 2349)
Castilleja de la Cuesta, Sevilla, Spain
HOSPITAL CLINICO DE VALENCIA-CARDIOLOGY ( Site 2321)
Valencia, Valenciana, Comunitat, Spain
Hospital Universitario 12 de Octubre-Internal Medicine. Unidad de Ensayos Clínicos ( Site 2319)
Madrid, , Spain
Chi Mei Medical Center-Cardiology ( Site 3104)
Tainan City, Tainan, Taiwan
Changhua Christian Hospital ( Site 3101)
Changhua, , Taiwan
Chang Gung Memorial Hospital at Kaohsiung ( Site 3102)
Kaohsiung City, , Taiwan
National Cheng Kung University Hospital ( Site 3107)
Tainan City, , Taiwan
National Taiwan University Hospital ( Site 3100)
Taipei, , Taiwan
Taipei Medical University Hospital-Cardiology ( Site 3108)
Taipei, , Taiwan
Taipei Veterans General Hospital ( Site 3106)
Taipei, , Taiwan
Hacettepe Universite Hastaneleri ( Site 2500)
Altindağ, Ankara, Turkey (Türkiye)
Ege Universitesi Hastanesi-Cardilogy Department ( Site 2502)
Bornova, İzmir, Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi-cardiology ( Site 2501)
Ankara, , Turkey (Türkiye)
Eskisehir Osmangazi University-Cardiology ( Site 2510)
Eskişehir, , Turkey (Türkiye)
Erciyes Universitesi Tıp Fakultesi Hastaneleri-endocrine ( Site 2522)
Kayseri, , Turkey (Türkiye)
Kocaeli Üniversitesi-Cardiology ( Site 2516)
Kocaeli, , Turkey (Türkiye)
Countries
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Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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MK-0616-013
Identifier Type: OTHER
Identifier Source: secondary_id
2022-502777-42-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1285-4164
Identifier Type: REGISTRY
Identifier Source: secondary_id
jRCT2031230320
Identifier Type: REGISTRY
Identifier Source: secondary_id
0616-013
Identifier Type: -
Identifier Source: org_study_id
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