Open-label Extension Study of Enlicitide Decanoate (MK-0616/Enlicitide Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-019) CORALreef Extension

NCT06492291 | Active Not Recruiting Phase 3 DMC FDA Drug

• 5 other identifiers: 0616-0192023-504922-20-00U1111-1290-3950jRCT2051240110MK-0616-019
• Study Type: interventional
• Target: 3,000
• Locations: 28 countries
• Sites: 222

Brief Summary

This is an extension study to evaluate the longer-term safety and efficacy of enlicitide decanoate in adults with hypercholesterolemia who completed either study MK-0616-013 (NCT05952856), study MK-0616-017 (NCT05952869), or study MK-0616-018 (NCT06450366).

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (2)

• 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 approximately 3 years

• 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 approximately 3 years

Secondary Outcomes (6)

• Mean percent change from baseline of the parent study in LDL-C at Week 8 of this extension study

  Baseline of the parent study and Week 8 of this extension study

• Mean percent change from baseline of the parent study in non-high-density lipoprotein cholesterol (non-HDL-C) at Week 8 of this Extension Study

  Baseline of the parent study and Week 8 of this extension study

• Mean percent change from baseline of the parent study in apolipoprotein B (ApoB) at Week 8 of this extension study

  Baseline of the parent study and Week 8 of this extension study

• Percent change from baseline of the parent study in lipoprotein(a) (Lp[a]) at Week 8 of this extension study

  Baseline of the parent study and Week 8 of this extension study

• Percentage of participants with LDL-C <70 mg/dL and ≥50% reduction from baseline of the parent study

  Baseline in the parent study and up to approximately 3 years in this extension study

Study Arms (1)

Enlicitide Decanoate

EXPERIMENTAL

Participants will receive 20 mg of enlicitide decanoate orally once daily (QD)

Drug: Enlicitide Decanoate

Interventions

Enlicitide Decanoate DRUG

Oral tablet

Also known as: MK-0616, Enlicitide

Enlicitide Decanoate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has completed an enlicitide decanoate (also known as enlictide and MK-0616) parent study \[MK-0616-013 (NCT05952856), MK-0616-017 (NCT05952869), and MK-0616-018 (NCT06450366)\] per protocol (including the final assessments/procedures of their parent study)
• Had an overall study intervention compliance ≥80% while participating in their parent study

You may not qualify if:

• Has discontinued study intervention in their parent study
• Has an ongoing serious adverse event considered related to study intervention by the investigator in the parent study
• Is planning to begin treatment with a nonstudy protein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) while enrolled in the study
• Is currently participating in an interventional clinical study other than an enlicitide decanoate parent study

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (222)

Alliance for Multispecialty Research, LLC ( Site 0027)

Daphne, Alabama, 36526, United States

Location

G&L Research ( Site 0035)

Foley, Alabama, 36535, United States

Location

Synexus Clinical Research US, Inc.-Synexus Clinical Research US, Inc - Central Phoenix ( Site 0048)

Phoenix, Arizona, 85020, United States

Location

National Heart Institute-Research ( Site 0029)

Beverly Hills, California, 90211, United States

Location

Clinical Trials Research ( Site 0054)

Sacramento, California, 95821, United States

Location

Velocity Clinical Research, Banning ( Site 0023)

San Bernardino, California, 92408, United States

Location

Emerson Clinical Research Institute ( Site 0017)

Washington D.C., District of Columbia, 20009, United States

Location

Excel Medical Clinical Trials ( Site 0010)

Boca Raton, Florida, 33434, United States

Location

Alliance for Multispecialty Research, LLC ( Site 0037)

Doral, Florida, 33172, United States

Location

Alliance for Multispecialty Research, LLC ( Site 0056)

Fort Myers, Florida, 33912, United States

Location

Velocity Clinical Research, Hallandale Beach ( Site 0053)

Hallandale, Florida, 33009, United States

Location

Jacksonville Center for Clinical Research ( Site 0025)

Jacksonville, Florida, 32216, United States

Location

South Broward Research ( Site 0012)

Miramar, Florida, 33027, United States

Location

Progressive Medical Research ( Site 0033)

Port Orange, Florida, 32127, United States

Location

Clinical Research Trials of Florida ( Site 0006)

Tampa, Florida, 33607, United States

Location

Clinical Site Partners, LLC dba Flourish Research ( Site 0004)

Winter Park, Florida, 32789, United States

Location

East Coast Institute for Research, LLC ( Site 0020)

Macon, Georgia, 31210, United States

Location

Healthcare Research Network - Chicago ( Site 0051)

Flossmoor, Illinois, 60422, United States

Location

Synexus Clinical Research US - Evansville ( Site 0005)

Evansville, Indiana, 47714, United States

Location

Midwest Institute For Clinical Research ( Site 0052)

Indianapolis, Indiana, 46260, United States

Location

Alliance for Multispecialty Research, LLC ( Site 0001)

Lexington, Kentucky, 40509, United States

Location

L-MARC Research Center ( Site 0011)

Louisville, Kentucky, 40213, United States

Location

Velocity Clinical Research, Covington ( Site 0026)

Covington, Louisiana, 70433, United States

Location

Velocity Clinical Research Rockville ( Site 0022)

Rockville, Maryland, 20854, United States

Location

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0018)

Troy, Michigan, 48098, United States

Location

Velocity Clinical Research, Gulfport ( Site 0032)

Gulfport, Mississippi, 39503, United States

Location

Healthcare Research Network - St. Louis ( Site 0040)

Hazelwood, Missouri, 63042, United States

Location

Velocity Clinical Research at The Pioneer Heart Institute, Lincoln ( Site 0031)

Lincoln, Nebraska, 68510, United States

Location

Jubilee Clinical Research ( Site 0049)

Las Vegas, Nevada, 89106, United States

Location

AB Clinical Trials ( Site 0002)

Las Vegas, Nevada, 89119, United States

Location

New Mexico Clinical Research & Osteoporosis Center ( Site 0043)

Albuquerque, New Mexico, 87106, United States

Location

Velocity Clinical Research, Syracuse ( Site 0014)

East Syracuse, New York, 13057, United States

Location

Icahn School of Medicine at Mount Sinai-Cardiology ( Site 0042)

New York, New York, 10029, United States

Location

Lillestol Research ( Site 0030)

Fargo, North Dakota, 58104, United States

Location

altoona center for clinical research ( Site 0024)

Duncansville, Pennsylvania, 16635, United States

Location

Cardiology Consultants of Philadelphia Yardley ( Site 0021)

Yardley, Pennsylvania, 19067, United States

Location

Velocity Clinical Research, Anderson ( Site 0015)

Anderson, South Carolina, 29621, United States

Location

Piedmont Research Partners ( Site 0045)

Fort Mill, South Carolina, 29707, United States

Location

Coastal Carolina Research Center ( Site 0055)

North Charleston, South Carolina, 29405, United States

Location

Monument Health Clinical Research, a department of Monument -Monument Health Clinical Research, a d ( Site 0038)

Rapid City, South Dakota, 57701, United States

Location

Holston Medical Group ( Site 0034)

Kingsport, Tennessee, 37660, United States

Location

Alliance for Multispecialty Research, LLC ( Site 0050)

Knoxville, Tennessee, 37920, United States

Location

Velocity Clinical Research, Dallas ( Site 0028)

Dallas, Texas, 75230, United States

Location

Center for Cardiometabolic Disease Prevention/Baylor College of Medicine ( Site 0009)

Houston, Texas, 77030, United States

Location

Clinical Trials of Texas, LLC ( Site 0016)

San Antonio, Texas, 78229, United States

Location

Synexus Clinical Research US, Inc. ( Site 0003)

Salt Lake City, Utah, 84106, United States

Location

Velocity Clinical Research, Salt Lake City ( Site 0041)

West Jordan, Utah, 84088, United States

Location

Manassas Clinical Research Center ( Site 0007)

Manassas, Virginia, 20110, United States

Location

Health Research of Hampton Roads, Inc. ( Site 0019)

Newport News, Virginia, 23606, United States

Location

Alliance for Multispecialty Research, LLC ( Site 0008)

Norfolk, Virginia, 23502, United States

Location

National Clinical Research, Inc ( Site 0044)

Richmond, Virginia, 23294, United States

Location

Rainier Clinical Research Center ( Site 0013)

Renton, Washington, 98057, United States

Location

CEDIC ( Site 0603)

CABA, Buenos Aires, C1060ABN, Argentina

Location

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0605)

CABA, Buenos Aires, C1425AGC, Argentina

Location

Instituto de Investigaciones Clínicas Mar del Plata ( Site 0602)

Mar del Plata, Buenos Aires, B7600FZO, Argentina

Location

Instituto de Investigaciones Clinicas Zarate ( Site 0604)

Zárate, Buenos Aires, B2800DGH, Argentina

Location

Fundacion Estudios Clinicos ( Site 0601)

Rosario, Santa Fe Province, S2000DEJ, Argentina

Location

Centro de Investigaciones Metabolicas CINME - Cardiology ( Site 0607)

CABA, C1056ABI, Argentina

Location

CIPREC ( Site 0600)

CABA, C1061AAS, Argentina

Location

Fundación Respirar ( Site 0606)

CABA, C1426ABP, Argentina

Location

Royal Prince Alfred Hospital-6West CV Ambulatory Care ( Site 2808)

Camperdown, New South Wales, 2050, Australia

Location

Victorian Heart Hospital-Monash Cardiovascular Research Centre (MCRC) ( Site 2803)

Clayton, Victoria, 3168, Australia

Location

Universidade Federal Do Ceara ( Site 0702)

Fortaleza, Ceará, 60430270, Brazil

Location

Instituto Dante Pazzanese de Cardiology ( Site 0701)

São Paulo, São Paulo, 04012-909, Brazil

Location

Incor - Instituto do Coracao ( Site 0703)

São Paulo, 05403-900, Brazil

Location

The Medical Arts Health Research Group ( Site 0506)

North Vancouver, British Columbia, V7M 2H4, Canada

Location

Cambridge Cardiac Care Centre ( Site 0502)

Cambridge, Ontario, N1R 6V6, Canada

Location

North York Diagnostic and Cardiac Centre ( Site 0505)

North York, Ontario, M6B 3H7, Canada

Location

Ecogene-21 ( Site 0500)

Chicoutimi, Quebec, G7H 7K9, Canada

Location

Institut de Cardiologie de Montreal ( Site 0504)

Montreal, Quebec, H1T 1C8, Canada

Location

Diex Recherche Trois-Rivieres ( Site 0503)

Trois-Rivières, Quebec, G9A 4P3, Canada

Location

Clinical Research Chile SpA ( Site 0800)

Valdivia, Los Ríos Region, 5110683, Chile

Location

CDIEM ( Site 0801)

Providencia, Region M. de Santiago, 7500859, Chile

Location

Pontificia Universidad Catolica de Chile-CICUC ( Site 0803)

Santiago, Region M. de Santiago, 8330034, Chile

Location

Beijing Anzhen Hospital, Capital Medical University-Cardiovascular ( Site 6000)

Beijing, Beijing Municipality, 100029, China

Location

Beijing Friendship Hospital Affiliate of Capital University ( Site 6003)

Beijing, Beijing Municipality, 100050, China

Location

The Second Affiliated Hospital of Chongqing Medical University ( Site 6020)

Chongqing, Chongqing Municipality, 400072, China

Location

Chongqing University Three Gorges Hospital ( Site 6021)

Chongqing, Chongqing Municipality, 404100, China

Location

Guangdong Provincial People s Hospital ( Site 6004)

Guangzhou, Guangdong, 510080, China

Location

Zhujiang Hospital ( Site 6029)

Guangzhou, Guangdong, 510280, China

Location

Huizhou Municipal Central Hospital ( Site 6079)

Huizhou, Guangdong, 516001, China

Location

The University of Hong Kong-Shenzhen Hospital ( Site 6018)

Shenzhen, Guangdong, 518053, China

Location

Jingzhou Central Hospital ( Site 6076)

Jingzhou, Hubei, 434036, China

Location

Wuhan Fourth Hospital ( Site 6056)

Wuhan, Hubei, 430030, China

Location

Hunan Provincial People's Hospital ( Site 6017)

Changsha, Hunan, 400000, China

Location

Changzhou Second People's Hospital ( Site 6073)

Changzhou, Jiangsu, 213000, China

Location

Northern Jiangsu People s Hospital ( Site 6008)

Yangzhou, Jiangsu, 225001, China

Location

The Third Hospital of Nanchang - Fuhe ( Site 6078)

Nanchang, Jiangxi, 330003, China

Location

Siping Central People's Hospital ( Site 6011)

Siping, Jilin, 136000, China

Location

Xianyang Hospital of Yan'an University ( Site 6040)

Xianyang, Shaanxi, 712000, China

Location

Chengdu Second Municipal People's Hospital ( Site 6032)

Chengdu, Sichuan, 610021, China

Location

Lishui City People s Hospital ( Site 6002)

Lishui, Zhejiang, 323000, China

Location

Fundación Centro de Investigación Clínica CIC ( Site 0904)

Medellín, Antioquia, 050021, Colombia

Location

Ciensalud Ips S A S ( Site 0900)

Barranquilla, Atlántico, 08001, Colombia

Location

Clinica de la Costa S.A.S. ( Site 0901)

Barranquilla, Atlántico, 080020, Colombia

Location

Salud SURA Calle 100 ( Site 0905)

Bogotá, Cundinamarca, 110231, Colombia

Location

Healthy Medical Center S.A.S ( Site 0902)

Zipaquirá, Cundinamarca, 250252, Colombia

Location

Fundación Valle del Lili ( Site 0903)

Cali, Valle del Cauca Department, 760032, Colombia

Location

Fakultni Nemocnice u sv. Anny v Brne ( Site 3604)

Brno, Brno-mesto, 602 00, Czechia

Location

Fakultní nemocnice Brno Bohunice-Interni kardiologicka klinika ( Site 3602)

Brno, Brno-mesto, 625 00, Czechia

Location

Institut Klinicke a Experimentalni Mediciny ( Site 3601)

Prague, Praha 4, 14021, Czechia

Location

Meilahden tornisairaala - Meilahti Tower Hospital ( Site 1300)

Helsinki, Uusimaa, 00290, Finland

Location

Hôpital Arnaud de Villeneuve - CHU Montpellier ( Site 5002)

Montpellier, Herault, 34090, France

Location

Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes ( Site 5004)

Saint-Herblain, Loire-Atlantique, 44800, France

Location

Hospices Civils de Lyon - Hopital Louis Pradel-Service d'endocrinologie, de diabétologie et des mal ( Site 5000)

Bron, Rhone, 69677, France

Location

Unterfrintroper Hausarztzentrum Klinische Forschung ( Site 1543)

Essen, North Rhine-Westphalia, 45359, Germany

Location

Universitaetsklinikum Carl Gustav Carus Dresden-Universitätsstudienzentrum für Stoffwechselerkranku ( Site 1510)

Dresden, Saxony, 01307, Germany

Location

Hausarzt- und Diabetologische Schwerpunktpraxis Hohenmölsen - Weiβenfels ( Site 1528)

Hohenmölsen, Saxony-Anhalt, 06679, Germany

Location

Zentralklinik Bad Berka ( Site 1531)

Bad Berka, Thuringia, 99437, Germany

Location

Velocity Clinical Research GmbH Berlin ( Site 1503)

Berlin, 10787, Germany

Location

Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 1534)

Berlin, 12203, Germany

Location

Queen Mary Hospital-Medical ( Site 3300)

Hksar, Hong Kong

Location

Prince of Wales Hospital ( Site 3304)

Shatin, Hong Kong

Location

Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Belgyógyászati Klinika ( Site 1603)

Szeged, Csongrád megye, 6725, Hungary

Location

Semmelweis Egyetem-Városmajori Szív- és Érgyógyászati Klinika ( Site 1600)

Budapest, 1122, Hungary

Location

Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Anyagcsere Tanszék) ( Site 1601)

Debrecen, 4032, Hungary

Location

Hillel Yaffe Medical Center ( Site 1731)

Hadera, 3810101, Israel

Location

Rambam Health Care Campus ( Site 1739)

Haifa, 3109601, Israel

Location

Rambam Health Care Campus ( Site 1742)

Haifa, 3109601, Israel

Location

Shaare Zedek Medical Center ( Site 1735)

Jerusalem, 9103102, Israel

Location

Hadassah Medical Center ( Site 1732)

Jerusalem, 9112001, Israel

Location

Hadassah Medical Center ( Site 1741)

Jerusalem, 9112001, Israel

Location

Hadassah Medical Center-Heart Institute ( Site 1734)

Jerusalem, 9112001, Israel

Location

Meir Medical Center. ( Site 1737)

Kfar Saba, 4428164, Israel

Location

Rabin Medical Center ( Site 1738)

Petah Tikva, 4941492, Israel

Location

Rabin Medical Center ( Site 1740)

Petah Tikva, 4941492, Israel

Location

Sheba Medical Center ( Site 1733)

Ramat Gan, 5265601, Israel

Location

Clalit Health Services - Sakhnin Community Clinic ( Site 1730)

Sakhnin, 3081000, Israel

Location

Yitzhak Shamir Medical Center. ( Site 1736)

Ẕerifin, 7033001, Israel

Location

Fondazione Policlinico Tor Vergata ( Site 1809)

Rome, Lazio, 00133, Italy

Location

Centro Cardiologico Monzino ( Site 1804)

Milan, Milano, 20138, Italy

Location

Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino ( Site 1801)

Turin, Piedmont, 10126, Italy

Location

Azienda Ospedaliera Sant'Andrea-Department of Clinical and Molecular Medicine ( Site 1807)

Rome, Roma, 00189, Italy

Location

Azienda Ospedaliera Garibaldi ( Site 1810)

Catania, 95122, Italy

Location

Hirohata Naika Clinic ( Site 3513)

Kitakyushu, Fukuoka, 807-0857, Japan

Location

Nakakinen clinic ( Site 3510)

Naka, Ibaraki, 311-0113, Japan

Location

Noritake Clinic ( Site 3512)

Ushiku, Ibaraki, 300-1207, Japan

Location

National Hospital Organization Kanazawa Medical Center ( Site 3508)

Kanazawa, Ishikawa-ken, 920-8650, Japan

Location

Hirano Medical Clinic ( Site 3522)

Morioka, Iwate, 020-0132, Japan

Location

Shirai Healthcare Clinic Izumichuou ( Site 3527)

Sendai, Miyagi, 981-3133, Japan

Location

Rinku General Medical Center ( Site 3503)

Izumisano, Osaka, 598-8577, Japan

Location

Shiraiwa Medical Clinic ( Site 3514)

Kashihara, Osaka, 582-0005, Japan

Location

Medical Corporation Heishinkai OCROM Clinic ( Site 3501)

Suita-shi, Osaka, 565-0853, Japan

Location

Saitama Medical University Hospital ( Site 3506)

Iruma, Saitama, 350-0495, Japan

Location

Teramoto Medical and Dental Clinic ( Site 3507)

Bunkyo-ku, Tokyo, 113-0033, Japan

Location

Tokyo-Eki Center-building Clinic ( Site 3505)

Chuo-ku, Tokyo, 103-0027, Japan

Location

Fukuwa Clinic ( Site 3504)

Chuo-ku, Tokyo, 104-0031, Japan

Location

Teikyo University Hospital ( Site 3500)

Itabashi-ku, Tokyo, 173-8606, Japan

Location

Kato Clinic of Internal Medicine ( Site 3509)

Katsushika-ku, Tokyo, 125-0054, Japan

Location

Kanno Naika ( Site 3511)

Mitaka, Tokyo, 181-0013, Japan

Location

Sugawara Clinic ( Site 3519)

Nerima-ku, Tokyo, 177-0041, Japan

Location

Shin Clinic ( Site 3517)

Ōta-ku, Tokyo, 144-0051, Japan

Location

Medical Corporation Heishinkai ToCROM Clinic ( Site 3502)

Shinjuku-ku, Tokyo, 160-0008, Japan

Location

Medical Corporation Hakuaikai Wellness Tenjin Clinic ( Site 3520)

Fukuoka, 810-0001, Japan

Location

Hiroshima City Hiroshima Citizens Hospital ( Site 3518)

Hiroshima, 730-8518, Japan

Location

Mishuku Hospital ( Site 3524)

Tokyo, 153-0051, Japan

Location

Mitsukoshi Health and Welfare Foundation ( Site 3521)

Tokyo, 160-0023, Japan

Location

Instituto Jalisciense de Investigacion en Diabetes y Obesidad-Endocrinology ( Site 1057)

Guadalajara, Jalisco, 44600, Mexico

Location

Instituto Nacional de Ciencias Medicas y Nutricion Salvador -Unidad de Investigación de Enfermedade ( Site 1071)

Mexico City, Mexico City, 14080, Mexico

Location

Radboudumc-internal medicine ( Site 1952)

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

Amsterdam UMC, locatie AMC-Vascular Medicine Clin Trial Unit ( Site 1954)

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Dijklander Ziekenhuis ( Site 1953)

Hoorn, North Holland, 1624 NP, Netherlands

Location

Universitair Medisch Centrum Utrecht-Vascular Medicine Research ( Site 1955)

Utrecht, 3584 CX, Netherlands

Location

Pacific Clinical Research Network - Rotorua ( Site 2902)

Rotorua, Bay of Plenty, 3010, New Zealand

Location

New Zealand Clinical Research (Christchurch) ( Site 2901)

Christchurch, Canterbury, 8011, New Zealand

Location

Nordlandssykehuset ( Site 2041)

Bodø, Nordland, 8005, Norway

Location

Oslo Universitetssykehus Aker-Lipidklinikken ( Site 2040)

Oslo, 0316, Norway

Location

Changi General Hospital ( Site 3211)

Singapore, Central Singapore, 529889, Singapore

Location

IATROS International ( Site 2204)

Bloemfontein, Free State, 9301, South Africa

Location

Charlotte Maxeke Johannesburg Academic Hospital ( Site 2202)

Johannesburg, Gauteng, 2193, South Africa

Location

Soweto Clinical Trials Centre ( Site 2203)

Soweto, Gauteng, 1818, South Africa

Location

TREAD Research ( Site 2201)

Cape Town, Western Cape, 7500, South Africa

Location

Tiervlei Trial Centre ( Site 2205)

Cape Town, Western Cape, 7530, South Africa

Location

University of Cape Town (UCT)-Medicine, Division of Lipidology ( Site 2200)

Cape Town, Western Cape, 7925, South Africa

Location

Wonju Severance Christian Hospital ( Site 3008)

Wŏnju, Kang-won-do, 26426, South Korea

Location

Chonnam National University Hospital ( Site 3014)

Gwangju, Kwangju-Kwangyokshi, 61469, South Korea

Location

Seoul National University Bundang Hospital ( Site 3005)

Seongnam, Kyonggi-do, 13620, South Korea

Location

Ajou University Hospital ( Site 3006)

Suwon, Kyonggi-do, 16499, South Korea

Location

Chungbuk National University Hospital ( Site 3011)

Cheongju-si, North Chungcheong, 28644, South Korea

Location

Dong-A University Hospital-Cardiology ( Site 3013)

Busan, Pusan-Kwangyokshi, 49201, South Korea

Location

Pusan National University Hospital-Internal Medicine ( Site 3012)

Busan, Pusan-Kwangyokshi, 49241, South Korea

Location

Inje University Haeundae Paik Hospital ( Site 3010)

Haeundae-gu, Pusan-Kwangyokshi, 48108, South Korea

Location

Keimyung University Dongsan Hospital CRC room 1 ( Site 3003)

Daegu, Taegu-Kwangyokshi, 42601, South Korea

Location

Seoul National University Hospital ( Site 3001)

Seoul, 03080, South Korea

Location

Kangbuk Samsung Hospital ( Site 3009)

Seoul, 03181, South Korea

Location

Severance Hospital, Yonsei University Health System ( Site 3002)

Seoul, 03722, South Korea

Location

Asan Medical Center ( Site 3004)

Seoul, 05505, South Korea

Location

Samsung Medical Center-cardiology ( Site 3000)

Seoul, 06351, South Korea

Location

The Catholic Univ. of Korea Seoul St. Mary's Hospital-cardiology ( Site 3007)

Seoul, 06591, South Korea

Location

Hospital Universitario Virgen de la Victoria-UGC Endocrinologia y nutricion ( Site 2358)

Málaga, Andalusia, 29010, Spain

Location

EBA CENTELLES ( Site 2319)

Centelles, Barcelona, 08540, Spain

Location

Hospital Universitari Vall d'Hebron ( Site 2362)

Barcelona, Catalonia, 08035, Spain

Location

Hospital de Figueres ( Site 2361)

Figueres, Gerona, 17600, Spain

Location

Hospital Abente y Lago ( Site 2356)

A Coruña, La Coruna, 15001, Spain

Location

Hospital San Rafael de Coruna ( Site 2363)

A Coruña, La Coruna, 15006, Spain

Location

CHUS - Hospital Clinico Universitario-Cardiology - Clinical Research Unit ( Site 2320)

Santiago de Compostela, La Coruna, 15706, Spain

Location

HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 2344)

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Hospital Universitario Fundacion ALcorcon-Endocrinologia y Nutrición ( Site 2316)

Alcorcón, Madrid, Comunidad de, 28922, Spain

Location

Vithas Hospital Sevilla-Unidad de Salud Metabólica. Diabetes y Obesidad ( Site 2349)

Castilleja de la Cuesta, Sevilla, 41950, Spain

Location

Hospital Universitari Sant Joan de Reus ( Site 2329)

Reus, Tarragona, 43204, Spain

Location

HOSPITAL CLINICO DE VALENCIA-CARDIOLOGY ( Site 2321)

Valencia, Valenciana, Comunitat, 46010, Spain

Location

EAP Sardenya ( Site 2357)

Barcelona, 08025, Spain

Location

Hospital Universitario 12 de Octubre-Internal Medicine. Unidad de Ensayos Clínicos ( Site 2311)

Madrid, 28041, Spain

Location

Hospital Universitario Virgen Macarena-Cardiology ( Site 2352)

Seville, 41009, Spain

Location

Mackay Memorial Hospital -Tamsui Branch ( Site 3109)

New Taipei City, New Taipei, 251, Taiwan

Location

Chi Mei Medical Center ( Site 3104)

Tainan, Tainan, 71004, Taiwan

Location

Shin Kong Wu Ho-Su Memorial Hospital ( Site 3110)

Taipei City, Taipei, 111, Taiwan

Location

Changhua Christian Hospital ( Site 3101)

Changhua, 50006, Taiwan

Location

Chang Gung Memorial Hospital at Kaohsiung ( Site 3102)

Kaohsiung City, 83301, Taiwan

Location

National Cheng Kung University Hospital-Internal Medicine ( Site 3107)

Tainan, 704, Taiwan

Location

National Taiwan University Hospital ( Site 3100)

Taipei, 10002, Taiwan

Location

Taipei Medical University Hospital ( Site 3108)

Taipei, 110301, Taiwan

Location

Taipei Veterans General Hospital ( Site 3106)

Taipei, 112, Taiwan

Location

Chang Gung Medical Foundation-Linkou Branch ( Site 3105)

Taoyuan District, 33305, Taiwan

Location

Ege Universitesi Hastanesi-Cardilogy Department ( Site 2502)

Bornova, İzmir, 35100, Turkey (Türkiye)

Location

Hacettepe Universite Hastaneleri ( Site 2500)

Ankara, 06230, Turkey (Türkiye)

Location

Ankara Bilkent Şehir Hastanesi-cardiology ( Site 2501)

Ankara, 06800, Turkey (Türkiye)

Location

Eskisehir Osmangazi University-Cardiology ( Site 2510)

Eskişehir, 26480, Turkey (Türkiye)

Location

Erciyes Universitesi Tıp Fakultesi Hastaneleri ( Site 2522)

Kayseri, 38039, Turkey (Türkiye)

Location

Kocaeli Üniversitesi-Cardiology ( Site 2516)

Kocaeli, 41380, Turkey (Türkiye)

Location

Barts Health NHS Trust-William Harvey Clinical Research Centre ( Site 4001)

London, England, EC1M 6BQ, United Kingdom

Location

Royal Free Hospital ( Site 4000)

London, England, NW3 2QG, United Kingdom

Location

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

MK-0616

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 9, 2024
• Study Start: August 5, 2024
• Primary Completion (Estimated): October 13, 2028
• Study Completion (Estimated): October 13, 2028
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

HK (2); NZ (2); AR (8); AU (2); ZA (6); US (52); CZ (3); CL (3); NO (2); KR (15); TU (6); CN (18); IL (13); NL (4); CO (6); DE (6); CA (6); JP (23); FR (3); SG (1); IT (5); ES (15); HU (3); GB (2); TW (10); BR (3); FI (1); ME (2)