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

A Phase 3, Open-label Extension Study to Evaluate the Safety and Efficacy of MK-0616 in Adults With Hypercholesterolemia

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Drug: Enlicitide Decanoate

• Study Type: Interventional
• Enrollment (Estimated): 3000
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • CABA, Argentina, C1056ABI
    • Centro de Investigaciones Metabolicas CINME - Cardiology ( Site 0607)
  • CABA, Argentina, C1061AAS
    • CIPREC ( Site 0600)
  • CABA, Argentina, C1426ABP
    • Fundación Respirar ( Site 0606)
  • Buenos Aires
    • CABA, Buenos Aires, Argentina, C1060ABN
      • CEDIC ( Site 0603)
    • CABA, Buenos Aires, Argentina, C1425AGC
      • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0605)
    • Mar del Plata, Buenos Aires, Argentina, B7600FZO
      • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0602)
    • Zárate, Buenos Aires, Argentina, B2800DGH
      • Instituto de Investigaciones Clinicas Zarate ( Site 0604)
  • Santa Fe Province
    • Rosario, Santa Fe Province, Argentina, S2000DEJ
      • Fundacion Estudios Clinicos ( Site 0601)
• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Royal Prince Alfred Hospital-6West CV Ambulatory Care ( Site 2808)
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Victorian Heart Hospital-Monash Cardiovascular Research Centre (MCRC) ( Site 2803)
• Brazil
  • São Paulo, Brazil, 05403-900
    • Incor - Instituto do Coracao ( Site 0703)
  • Ceará
    • Fortaleza, Ceará, Brazil, 60430270
      • Universidade Federal Do Ceara ( Site 0702)
  • São Paulo
    • São Paulo, São Paulo, Brazil, 04012-909
      • Instituto Dante Pazzanese de Cardiology ( Site 0701)
• Canada
  • British Columbia
    • North Vancouver, British Columbia, Canada, V7M 2H4
      • The Medical Arts Health Research Group ( Site 0506)
  • Ontario
    • Cambridge, Ontario, Canada, N1R 6V6
      • Cambridge Cardiac Care Centre ( Site 0502)
    • North York, Ontario, Canada, M6B 3H7
      • North York Diagnostic and Cardiac Centre ( Site 0505)
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 7K9
      • Ecogene-21 ( Site 0500)
    • Montreal, Quebec, Canada, H1T 1C8
      • Institut de Cardiologie de Montreal ( Site 0504)
    • Trois-Rivières, Quebec, Canada, G9A 4P3
      • Diex Recherche Trois-Rivieres ( Site 0503)
• Chile
  • Los Ríos Region
    • Valdivia, Los Ríos Region, Chile, 5110683
      • Clinical Research Chile SpA ( Site 0800)
  • Region M. de Santiago
    • Providencia, Region M. de Santiago, Chile, 7500859
      • CDIEM ( Site 0801)
    • Santiago, Region M. de Santiago, Chile, 8330034
      • Pontificia Universidad Catolica de Chile-CICUC ( Site 0803)
• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100029
      • Beijing Anzhen Hospital, Capital Medical University-Cardiovascular ( Site 6000)
    • Beijing, Beijing Municipality, China, 100050
      • Beijing Friendship Hospital Affiliate of Capital University ( Site 6003)
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400072
      • The Second Affiliated Hospital of Chongqing Medical University ( Site 6020)
    • Chongqing, Chongqing Municipality, China, 404100
      • Chongqing University Three Gorges Hospital ( Site 6021)
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Guangdong Provincial People s Hospital ( Site 6004)
    • Guangzhou, Guangdong, China, 510280
      • Zhujiang Hospital ( Site 6029)
    • Huizhou, Guangdong, China, 516001
      • Huizhou Municipal Central Hospital ( Site 6079)
    • Shenzhen, Guangdong, China, 518053
      • The University of Hong Kong-Shenzhen Hospital ( Site 6018)
  • Hubei
    • Jingzhou, Hubei, China, 434036
      • Jingzhou Central Hospital ( Site 6076)
    • Wuhan, Hubei, China, 430030
      • Wuhan Fourth Hospital ( Site 6056)
  • Hunan
    • Changsha, Hunan, China, 400000
      • Hunan Provincial People's Hospital ( Site 6017)
  • Jiangsu
    • Changzhou, Jiangsu, China, 213000
      • Changzhou Second People's Hospital ( Site 6073)
    • Yangzhou, Jiangsu, China, 225001
      • Northern Jiangsu People s Hospital ( Site 6008)
  • Jiangxi
    • Nanchang, Jiangxi, China, 330003
      • The Third Hospital of Nanchang - Fuhe ( Site 6078)
  • Jilin
    • Siping, Jilin, China, 136000
      • Siping Central People's Hospital ( Site 6011)
  • Shaanxi
    • Xianyang, Shaanxi, China, 712000
      • Xianyang Hospital of Yan'an University ( Site 6040)
  • Sichuan
    • Chengdu, Sichuan, China, 610021
      • Chengdu Second Municipal People's Hospital ( Site 6032)
  • Zhejiang
    • Lishui, Zhejiang, China, 323000
      • Lishui City People s Hospital ( Site 6002)
• Colombia
  • Antioquia
    • Medellín, Antioquia, Colombia, 050021
      • Fundación Centro de Investigación Clínica CIC ( Site 0904)
  • Atlántico
    • Barranquilla, Atlántico, Colombia, 08001
      • Ciensalud Ips S A S ( Site 0900)
    • Barranquilla, Atlántico, Colombia, 080020
      • Clinica de la Costa S.A.S. ( Site 0901)
  • Cundinamarca
    • Bogotá, Cundinamarca, Colombia, 110231
      • Salud SURA Calle 100 ( Site 0905)
    • Zipaquirá, Cundinamarca, Colombia, 250252
      • Healthy Medical Center S.A.S ( Site 0902)
  • Valle del Cauca Department
    • Santiago de Cali, Valle del Cauca Department, Colombia, 760032
      • Fundación Valle del Lili ( Site 0903)
• Czechia
  • Brno-mesto
    • Brno, Brno-mesto, Czechia, 625 00
      • Fakultní nemocnice Brno Bohunice-Interni kardiologicka klinika ( Site 3602)
    • Brno, Brno-mesto, Czechia, 602 00
      • Fakultni Nemocnice u sv. Anny v Brne ( Site 3604)
  • Praha 4
    • Prague, Praha 4, Czechia, 14021
      • Institut Klinicke a Experimentalni Mediciny ( Site 3601)
• Finland
  • Uusimaa
    • Helsinki, Uusimaa, Finland, 00290
      • Meilahden tornisairaala - Meilahti Tower Hospital ( Site 1300)
• France
  • Herault
    • Montpellier, Herault, France, 34090
      • Hôpital Arnaud de Villeneuve - CHU Montpellier ( Site 5002)
  • Loire-Atlantique
    • Saint-Herblain, Loire-Atlantique, France, 44800
      • Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes ( Site 5004)
  • Rhone
    • Bron, Rhone, France, 69677
      • Hospices Civils de Lyon - Hopital Louis Pradel-Service d'endocrinologie, de diabétologie et des mal ( Site 5000)
• Germany
  • Berlin, Germany, 10787
    • Velocity Clinical Research GmbH Berlin ( Site 1503)
  • Berlin, Germany, 12203
    • Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 1534)
  • North Rhine-Westphalia
    • Essen, North Rhine-Westphalia, Germany, 45359
      • Unterfrintroper Hausarztzentrum Klinische Forschung ( Site 1543)
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Universitaetsklinikum Carl Gustav Carus Dresden-Universitätsstudienzentrum für Stoffwechselerkranku ( Site 1510)
  • Saxony-Anhalt
    • Hohenmölsen, Saxony-Anhalt, Germany, 06679
      • Hausarzt- und Diabetologische Schwerpunktpraxis Hohenmölsen - Weiβenfels ( Site 1528)
  • Thuringia
    • Bad Berka, Thuringia, Germany, 99437
      • Zentralklinik Bad Berka ( Site 1531)
• Hong Kong
  • Hksar, Hong Kong
    • Queen Mary Hospital-Medical ( Site 3300)
  • Shatin, Hong Kong
    • Prince of Wales Hospital ( Site 3304)
• Hungary
  • Budapest, Hungary, 1122
    • Semmelweis Egyetem-Városmajori Szív- és Érgyógyászati Klinika ( Site 1600)
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Anyagcsere Tanszék) ( Site 1601)
  • Csongrád megye
    • Szeged, Csongrád megye, Hungary, 6725
      • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Belgyógyászati Klinika ( Site 1603)
• Israel
  • Hadera, Israel, 3810101
    • Hillel Yaffe Medical Center ( Site 1731)
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus ( Site 1739)
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus ( Site 1742)
  • Jerusalem, Israel, 9103102
    • Shaare Zedek Medical Center ( Site 1735)
  • Jerusalem, Israel, 9112001
    • Hadassah Medical Center ( Site 1732)
  • Jerusalem, Israel, 9112001
    • Hadassah Medical Center ( Site 1741)
  • Jerusalem, Israel, 9112001
    • Hadassah Medical Center-Heart Institute ( Site 1734)
  • Kfar Saba, Israel, 4428164
    • Meir Medical Center. ( Site 1737)
  • Petah Tikva, Israel, 4941492
    • Rabin Medical Center ( Site 1738)
  • Petah Tikva, Israel, 4941492
    • Rabin Medical Center ( Site 1740)
  • Ramat Gan, Israel, 5265601
    • Sheba Medical Center ( Site 1733)
  • Sakhnin, Israel, 3081000
    • Clalit Health Services - Sakhnin Community Clinic ( Site 1730)
  • Ẕerifin, Israel, 7033001
    • Yitzhak Shamir Medical Center. ( Site 1736)
• Italy
  • Catania, Italy, 95122
    • Azienda Ospedaliera Garibaldi ( Site 1810)
  • Lazio
    • Rome, Lazio, Italy, 00133
      • Fondazione Policlinico Tor Vergata ( Site 1809)
  • Milano
    • Milan, Milano, Italy, 20138
      • Centro Cardiologico Monzino ( Site 1804)
  • Piedmont
    • Turin, Piedmont, Italy, 10126
      • Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino ( Site 1801)
  • Roma
    • Rome, Roma, Italy, 00189
      • Azienda Ospedaliera Sant'Andrea-Department of Clinical and Molecular Medicine ( Site 1807)
• Japan
  • Fukuoka, Japan, 810-0001
    • Medical Corporation Hakuaikai Wellness Tenjin Clinic ( Site 3520)
  • Hiroshima, Japan, 730-8518
    • Hiroshima City Hiroshima Citizens Hospital ( Site 3518)
  • Tokyo, Japan, 153-0051
    • Mishuku Hospital ( Site 3524)
  • Tokyo, Japan, 160-0023
    • Mitsukoshi Health and Welfare Foundation ( Site 3521)
  • Fukuoka
    • Kitakyushu, Fukuoka, Japan, 807-0857
      • Hirohata Naika Clinic ( Site 3513)
  • Ibaraki
    • Naka, Ibaraki, Japan, 311-0113
      • Nakakinen clinic ( Site 3510)
    • Ushiku, Ibaraki, Japan, 300-1207
      • Noritake Clinic ( Site 3512)
  • Ishikawa-ken
    • Kanazawa, Ishikawa-ken, Japan, 920-8650
      • National Hospital Organization Kanazawa Medical Center ( Site 3508)
  • Iwate
    • Morioka, Iwate, Japan, 020-0132
      • Hirano Medical Clinic ( Site 3522)
  • Miyagi
    • Sendai, Miyagi, Japan, 981-3133
      • Shirai Healthcare Clinic Izumichuou ( Site 3527)
  • Osaka
    • Izumisano, Osaka, Japan, 598-8577
      • Rinku General Medical Center ( Site 3503)
    • Kashihara, Osaka, Japan, 582-0005
      • Shiraiwa Medical Clinic ( Site 3514)
    • Suita-shi, Osaka, Japan, 565-0853
      • Medical Corporation Heishinkai OCROM Clinic ( Site 3501)
  • Saitama
    • Iruma, Saitama, Japan, 350-0495
      • Saitama Medical University Hospital ( Site 3506)
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-0033
      • Teramoto Medical and Dental Clinic ( Site 3507)
    • Chuo-ku, Tokyo, Japan, 103-0027
      • Tokyo-Eki Center-building Clinic ( Site 3505)
    • Chuo-ku, Tokyo, Japan, 104-0031
      • Fukuwa Clinic ( Site 3504)
    • Itabashi-ku, Tokyo, Japan, 173-8606
      • Teikyo University Hospital ( Site 3500)
    • Katsushika-ku, Tokyo, Japan, 125-0054
      • Kato Clinic of Internal Medicine ( Site 3509)
    • Mitaka, Tokyo, Japan, 181-0013
      • Kanno Naika ( Site 3511)
    • Nerima-ku, Tokyo, Japan, 177-0041
      • Sugawara Clinic ( Site 3519)
    • Shinjuku-ku, Tokyo, Japan, 160-0008
      • Medical Corporation Heishinkai ToCROM Clinic ( Site 3502)
    • Ōta-ku, Tokyo, Japan, 144-0051
      • Shin Clinic ( Site 3517)
• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44600
      • Instituto Jalisciense de Investigacion en Diabetes y Obesidad-Endocrinology ( Site 1057)
  • Mexico City
    • Mexico City, Mexico City, Mexico, 14080
      • Instituto Nacional de Ciencias Medicas y Nutricion Salvador -Unidad de Investigación de Enfermedade ( Site 1071)
• Netherlands
  • Utrecht, Netherlands, 3584 CX
    • Universitair Medisch Centrum Utrecht-Vascular Medicine Research ( Site 1955)
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6525 GA
      • Radboudumc-internal medicine ( Site 1952)
  • North Holland
    • Amsterdam, North Holland, Netherlands, 1105 AZ
      • Amsterdam UMC, locatie AMC-Vascular Medicine Clin Trial Unit ( Site 1954)
    • Hoorn, North Holland, Netherlands, 1624 NP
      • Dijklander Ziekenhuis ( Site 1953)
• New Zealand
  • Bay of Plenty
    • Rotorua, Bay of Plenty, New Zealand, 3010
      • Pacific Clinical Research Network - Rotorua ( Site 2902)
  • Canterbury
    • Christchurch, Canterbury, New Zealand, 8011
      • New Zealand Clinical Research (Christchurch) ( Site 2901)
• Norway
  • Oslo, Norway, 0316
    • Oslo Universitetssykehus Aker-Lipidklinikken ( Site 2040)
  • Nordland
    • Bodø, Nordland, Norway, 8005
      • Nordlandssykehuset ( Site 2041)
• Singapore
  • Central Singapore
    • Singapore, Central Singapore, Singapore, 529889
      • Changi General Hospital ( Site 3211)
• South Africa
  • Free State
    • Bloemfontein, Free State, South Africa, 9301
      • IATROS International ( Site 2204)
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 2193
      • Charlotte Maxeke Johannesburg Academic Hospital ( Site 2202)
    • Soweto, Gauteng, South Africa, 1818
      • Soweto Clinical Trials Centre ( Site 2203)
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7500
      • TREAD Research ( Site 2201)
    • Cape Town, Western Cape, South Africa, 7530
      • Tiervlei Trial Centre ( Site 2205)
    • Cape Town, Western Cape, South Africa, 7925
      • University of Cape Town (UCT)-Medicine, Division of Lipidology ( Site 2200)
• South Korea
  • Seoul, South Korea, 03080
    • Seoul National University Hospital ( Site 3001)
  • Seoul, South Korea, 03181
    • Kangbuk Samsung Hospital ( Site 3009)
  • Seoul, South Korea, 03722
    • Severance Hospital, Yonsei University Health System ( Site 3002)
  • Seoul, South Korea, 05505
    • Asan Medical Center ( Site 3004)
  • Seoul, South Korea, 06351
    • Samsung Medical Center-cardiology ( Site 3000)
  • Seoul, South Korea, 06591
    • The Catholic Univ. of Korea Seoul St. Mary's Hospital-cardiology ( Site 3007)
  • Kang-won-do
    • Wŏnju, Kang-won-do, South Korea, 26426
      • Wonju Severance Christian Hospital ( Site 3008)
  • Kwangju-Kwangyokshi
    • Gwangju, Kwangju-Kwangyokshi, South Korea, 61469
      • Chonnam National University Hospital ( Site 3014)
  • Kyonggi-do
    • Seongnam, Kyonggi-do, South Korea, 13620
      • Seoul National University Bundang Hospital ( Site 3005)
    • Suwon, Kyonggi-do, South Korea, 16499
      • Ajou University Hospital ( Site 3006)
  • North Chungcheong
    • Cheongju-si, North Chungcheong, South Korea, 28644
      • Chungbuk National University Hospital ( Site 3011)
  • Pusan-Kwangyokshi
    • Busan, Pusan-Kwangyokshi, South Korea, 49201
      • Dong-A University Hospital-Cardiology ( Site 3013)
    • Busan, Pusan-Kwangyokshi, South Korea, 49241
      • Pusan National University Hospital-Internal Medicine ( Site 3012)
    • Haeundae-gu, Pusan-Kwangyokshi, South Korea, 48108
      • Inje University Haeundae Paik Hospital ( Site 3010)
  • Taegu-Kwangyokshi
    • Daegu, Taegu-Kwangyokshi, South Korea, 42601
      • Keimyung University Dongsan Hospital CRC room 1 ( Site 3003)
• Spain
  • Barcelona, Spain, 08025
    • EAP Sardenya ( Site 2357)
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre-Internal Medicine. Unidad de Ensayos Clínicos ( Site 2311)
  • Seville, Spain, 41009
    • Hospital Universitario Virgen Macarena-Cardiology ( Site 2352)
  • Andalusia
    • Málaga, Andalusia, Spain, 29010
      • Hospital Universitario Virgen de la Victoria-UGC Endocrinologia y nutricion ( Site 2358)
  • Barcelona
    • Centelles, Barcelona, Spain, 08540
      • EBA CENTELLES ( Site 2319)
  • Catalonia
    • Barcelona, Catalonia, Spain, 08035
      • Hospital Universitari Vall d'Hebron ( Site 2362)
  • Gerona
    • Figueres, Gerona, Spain, 17600
      • Hospital de Figueres ( Site 2361)
  • La Coruna
    • A Coruña, La Coruna, Spain, 15001
      • Hospital Abente y Lago ( Site 2356)
    • A Coruña, La Coruna, Spain, 15006
      • Hospital San Rafael de Coruna ( Site 2363)
    • Santiago de Compostela, La Coruna, Spain, 15706
      • CHUS - Hospital Clinico Universitario-Cardiology - Clinical Research Unit ( Site 2320)
  • Madrid
    • Pozuelo de Alarcón, Madrid, Spain, 28223
      • HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 2344)
  • Madrid, Comunidad de
    • Alcorcón, Madrid, Comunidad de, Spain, 28922
      • Hospital Universitario Fundacion ALcorcon-Endocrinologia y Nutrición ( Site 2316)
  • Sevilla
    • Castilleja de la Cuesta, Sevilla, Spain, 41950
      • Vithas Hospital Sevilla-Unidad de Salud Metabólica. Diabetes y Obesidad ( Site 2349)
  • Tarragona
    • Reus, Tarragona, Spain, 43204
      • Hospital Universitari Sant Joan de Reus ( Site 2329)
  • Valenciana, Comunitat
    • Valencia, Valenciana, Comunitat, Spain, 46010
      • HOSPITAL CLINICO DE VALENCIA-CARDIOLOGY ( Site 2321)
• Taiwan
  • Changhua, Taiwan, 50006
    • Changhua Christian Hospital ( Site 3101)
  • Kaohsiung City, Taiwan, 83301
    • Chang Gung Memorial Hospital at Kaohsiung ( Site 3102)
  • Tainan City, Taiwan, 704
    • National Cheng Kung University Hospital-Internal Medicine ( Site 3107)
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital ( Site 3100)
  • Taipei, Taiwan, 112
    • Taipei Veterans General Hospital ( Site 3106)
  • Taipei, Taiwan, 110301
    • Taipei Medical University Hospital ( Site 3108)
  • Taoyuan District, Taiwan, 33305
    • Chang Gung Medical Foundation-Linkou Branch ( Site 3105)
  • New Taipei
    • New Taipei City, New Taipei, Taiwan, 251
      • Mackay Memorial Hospital -Tamsui Branch ( Site 3109)
  • Tainan
    • Tainan City, Tainan, Taiwan, 71004
      • Chi Mei Medical Center ( Site 3104)
  • Taipei
    • Taipei City, Taipei, Taiwan, 111
      • Shin Kong Wu Ho-Su Memorial Hospital ( Site 3110)
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06800
    • Ankara Bilkent Şehir Hastanesi-cardiology ( Site 2501)
  • Ankara, Turkey (Türkiye), 06230
    • Hacettepe Universite Hastaneleri ( Site 2500)
  • Eskişehir, Turkey (Türkiye), 26480
    • Eskisehir Osmangazi University-Cardiology ( Site 2510)
  • Kayseri, Turkey (Türkiye), 38039
    • Erciyes Universitesi Tıp Fakultesi Hastaneleri ( Site 2522)
  • Kocaeli, Turkey (Türkiye), 41380
    • Kocaeli Üniversitesi-Cardiology ( Site 2516)
  • İzmir
    • Bornova, İzmir, Turkey (Türkiye), 35100
      • Ege Universitesi Hastanesi-Cardilogy Department ( Site 2502)
• United Kingdom
  • England
    • London, England, United Kingdom, EC1M 6BQ
      • Barts Health NHS Trust-William Harvey Clinical Research Centre ( Site 4001)
    • London, England, United Kingdom, NW3 2QG
      • Royal Free Hospital ( Site 4000)
• United States
  • Alabama
    • Daphne, Alabama, United States, 36526
      • Alliance for Multispecialty Research, LLC ( Site 0027)
    • Foley, Alabama, United States, 36535
      • G&L Research ( Site 0035)
  • Arizona
    • Phoenix, Arizona, United States, 85020
      • Synexus Clinical Research US, Inc.-Synexus Clinical Research US, Inc - Central Phoenix ( Site 0048)
  • California
    • Beverly Hills, California, United States, 90211
      • National Heart Institute-Research ( Site 0029)
    • Sacramento, California, United States, 95821
      • Clinical Trials Research ( Site 0054)
    • San Bernardino, California, United States, 92408
      • Velocity Clinical Research, Banning ( Site 0023)
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20009
      • Emerson Clinical Research Institute ( Site 0017)
  • Florida
    • Boca Raton, Florida, United States, 33434
      • Excel Medical Clinical Trials ( Site 0010)
    • Doral, Florida, United States, 33172
      • Alliance for Multispecialty Research, LLC ( Site 0037)
    • Fort Myers, Florida, United States, 33912
      • Alliance for Multispecialty Research, LLC ( Site 0056)
    • Hallandale, Florida, United States, 33009
      • Velocity Clinical Research, Hallandale Beach ( Site 0053)
    • Jacksonville, Florida, United States, 32216
      • Jacksonville Center for Clinical Research ( Site 0025)
    • Miramar, Florida, United States, 33027
      • South Broward Research ( Site 0012)
    • Port Orange, Florida, United States, 32127
      • Progressive Medical Research ( Site 0033)
    • Tampa, Florida, United States, 33607
      • Clinical Research Trials of Florida ( Site 0006)
    • Winter Park, Florida, United States, 32789
      • Clinical Site Partners, LLC dba Flourish Research ( Site 0004)
  • Georgia
    • Macon, Georgia, United States, 31210
      • East Coast Institute for Research, LLC ( Site 0020)
  • Illinois
    • Flossmoor, Illinois, United States, 60422
      • Healthcare Research Network - Chicago ( Site 0051)
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Synexus Clinical Research US - Evansville ( Site 0005)
    • Indianapolis, Indiana, United States, 46260
      • Midwest Institute For Clinical Research ( Site 0052)
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Alliance for Multispecialty Research, LLC ( Site 0001)
    • Louisville, Kentucky, United States, 40213
      • L-MARC Research Center ( Site 0011)
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • Velocity Clinical Research, Covington ( Site 0026)
  • Maryland
    • Rockville, Maryland, United States, 20854
      • Velocity Clinical Research Rockville ( Site 0022)
  • Michigan
    • Troy, Michigan, United States, 48098
      • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0018)
  • Mississippi
    • Gulfport, Mississippi, United States, 39503
      • Velocity Clinical Research, Gulfport ( Site 0032)
  • Missouri
    • Hazelwood, Missouri, United States, 63042
      • Healthcare Research Network - St. Louis ( Site 0040)
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Velocity Clinical Research at The Pioneer Heart Institute, Lincoln ( Site 0031)
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Jubilee Clinical Research ( Site 0049)
    • Las Vegas, Nevada, United States, 89119
      • AB Clinical Trials ( Site 0002)
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • New Mexico Clinical Research & Osteoporosis Center ( Site 0043)
  • New York
    • East Syracuse, New York, United States, 13057
      • Velocity Clinical Research, Syracuse ( Site 0014)
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai-Cardiology ( Site 0042)
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Lillestol Research ( Site 0030)
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • altoona center for clinical research ( Site 0024)
    • Yardley, Pennsylvania, United States, 19067
      • Cardiology Consultants of Philadelphia Yardley ( Site 0021)
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Velocity Clinical Research, Anderson ( Site 0015)
    • Fort Mill, South Carolina, United States, 29707
      • Piedmont Research Partners ( Site 0045)
    • North Charleston, South Carolina, United States, 29405
      • Coastal Carolina Research Center ( Site 0055)
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Monument Health Clinical Research, a department of Monument -Monument Health Clinical Research, a d ( Site 0038)
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Holston Medical Group ( Site 0034)
    • Knoxville, Tennessee, United States, 37920
      • Alliance for Multispecialty Research, LLC ( Site 0050)
  • Texas
    • Dallas, Texas, United States, 75230
      • Velocity Clinical Research, Dallas ( Site 0028)
    • Houston, Texas, United States, 77030
      • Center for Cardiometabolic Disease Prevention/Baylor College of Medicine ( Site 0009)
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas, LLC ( Site 0016)
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • Synexus Clinical Research US, Inc. ( Site 0003)
    • West Jordan, Utah, United States, 84088
      • Velocity Clinical Research, Salt Lake City ( Site 0041)
  • Virginia
    • Manassas, Virginia, United States, 20110
      • Manassas Clinical Research Center ( Site 0007)
    • Newport News, Virginia, United States, 23606
      • Health Research of Hampton Roads, Inc. ( Site 0019)
    • Norfolk, Virginia, United States, 23502
      • Alliance for Multispecialty Research, LLC ( Site 0008)
    • Richmond, Virginia, United States, 23294
      • National Clinical Research, Inc ( Site 0044)
  • Washington
    • Renton, Washington, United States, 98057
      • Rainier Clinical Research Center ( Site 0013)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enlicitide Decanoate; Participants will receive 20 mg of enlicitide decanoate orally once daily (QD)	Drug: Enlicitide Decanoate; Oral tablet; Other Names: MK-0616; Enlicitide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean percent change from baseline of the parent study in LDL-C at Week 8 of this extension study	The percent change from baseline in LDL-C. Each participant's baseline data from their parent study will be used as baseline data for this analysis.	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	The percent change from baseline in Non-HDL-C. Each participant's baseline data from their parent study will be used as baseline data for this analysis.	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	The percent change from baseline in apolipoprotein B. Each participant's baseline data from their parent study will be used as baseline data for this analysis.	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	The percent change from baseline in Lp(a). Each participant's baseline data from their parent study will be used as baseline data for this analysis.	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	The percentage of participants who have LDL-C <70 mg/dL and ≥50% reduction from baseline at any point during the study. Each participant's baseline data from their parent study will be used as baseline data for this analysis.	Baseline in the parent study and up to approximately 3 years in this extension study
Percentage of participants with LDL-C <55 mg/dL and ≥50% reduction from baseline of the parent study	The percentage of participants who have LDL-C <55 mg/dL and ≥50% reduction from baseline at any point during the study. Each participant's baseline data from their parent study will be used as baseline data for this analysis.	Baseline in the parent study and up to approximately 3 years in this extension study

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information
• Plain Language Summary

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2024
• Primary Completion (Estimated): October 13, 2028
• Study Completion (Estimated): October 13, 2028

Study Registration Dates

• First Submitted: July 1, 2024
• First Submitted That Met QC Criteria: July 1, 2024
• First Posted (Actual): July 9, 2024

Study Record Updates

• Last Update Posted (Estimated): October 7, 2025
• Last Update Submitted That Met QC Criteria: October 3, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Nutritional and Metabolic Diseases; Hypercholesterolemia; MK-0616
• Other Study ID Numbers: 0616-019; U1111-1290-3950 (Registry Identifier: UTN); jRCT2051240110 (Registry Identifier: jRCT); MK-0616-019 (Other Identifier: MSD); 2023-504922-20-00 (Registry Identifier: EU CT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No