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ACTIVE NOT RECRUITING
NCT06492291
PHASE3

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

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

3000

Start Date

2024-08-05

Completion Date

2028-10-13

Last Updated

2025-10-07

Healthy Volunteers

No

Interventions

DRUG

Enlicitide Decanoate

Oral tablet

Locations (222)

Alliance for Multispecialty Research, LLC ( Site 0027)

Daphne, Alabama, United States

G&L Research ( Site 0035)

Foley, Alabama, United States

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

Phoenix, Arizona, United States

National Heart Institute-Research ( Site 0029)

Beverly Hills, California, United States

Clinical Trials Research ( Site 0054)

Sacramento, California, United States

Velocity Clinical Research, Banning ( Site 0023)

San Bernardino, California, United States

Emerson Clinical Research Institute ( Site 0017)

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

Excel Medical Clinical Trials ( Site 0010)

Boca Raton, Florida, United States

Alliance for Multispecialty Research, LLC ( Site 0037)

Doral, Florida, United States

Alliance for Multispecialty Research, LLC ( Site 0056)

Fort Myers, Florida, United States

Velocity Clinical Research, Hallandale Beach ( Site 0053)

Hallandale, Florida, United States

Jacksonville Center for Clinical Research ( Site 0025)

Jacksonville, Florida, United States

South Broward Research ( Site 0012)

Miramar, Florida, United States

Progressive Medical Research ( Site 0033)

Port Orange, Florida, United States

Clinical Research Trials of Florida ( Site 0006)

Tampa, Florida, United States

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

Winter Park, Florida, United States

East Coast Institute for Research, LLC ( Site 0020)

Macon, Georgia, United States

Healthcare Research Network - Chicago ( Site 0051)

Flossmoor, Illinois, United States

Synexus Clinical Research US - Evansville ( Site 0005)

Evansville, Indiana, United States

Midwest Institute For Clinical Research ( Site 0052)

Indianapolis, Indiana, United States

Alliance for Multispecialty Research, LLC ( Site 0001)

Lexington, Kentucky, United States

L-MARC Research Center ( Site 0011)

Louisville, Kentucky, United States

Velocity Clinical Research, Covington ( Site 0026)

Covington, Louisiana, United States

Velocity Clinical Research Rockville ( Site 0022)

Rockville, Maryland, United States

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

Troy, Michigan, United States

Velocity Clinical Research, Gulfport ( Site 0032)

Gulfport, Mississippi, United States

Healthcare Research Network - St. Louis ( Site 0040)

Hazelwood, Missouri, United States

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

Lincoln, Nebraska, United States

Jubilee Clinical Research ( Site 0049)

Las Vegas, Nevada, United States

AB Clinical Trials ( Site 0002)

Las Vegas, Nevada, United States

New Mexico Clinical Research & Osteoporosis Center ( Site 0043)

Albuquerque, New Mexico, United States

Velocity Clinical Research, Syracuse ( Site 0014)

East Syracuse, New York, United States

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

New York, New York, United States

Lillestol Research ( Site 0030)

Fargo, North Dakota, United States

altoona center for clinical research ( Site 0024)

Duncansville, Pennsylvania, United States

Cardiology Consultants of Philadelphia Yardley ( Site 0021)

Yardley, Pennsylvania, United States

Velocity Clinical Research, Anderson ( Site 0015)

Anderson, South Carolina, United States

Piedmont Research Partners ( Site 0045)

Fort Mill, South Carolina, United States

Coastal Carolina Research Center ( Site 0055)

North Charleston, South Carolina, United States

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

Rapid City, South Dakota, United States

Holston Medical Group ( Site 0034)

Kingsport, Tennessee, United States

Alliance for Multispecialty Research, LLC ( Site 0050)

Knoxville, Tennessee, United States

Velocity Clinical Research, Dallas ( Site 0028)

Dallas, Texas, United States

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

Houston, Texas, United States

Clinical Trials of Texas, LLC ( Site 0016)

San Antonio, Texas, United States

Synexus Clinical Research US, Inc. ( Site 0003)

Salt Lake City, Utah, United States

Velocity Clinical Research, Salt Lake City ( Site 0041)

West Jordan, Utah, United States

Manassas Clinical Research Center ( Site 0007)

Manassas, Virginia, United States

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

Newport News, Virginia, United States

Alliance for Multispecialty Research, LLC ( Site 0008)

Norfolk, Virginia, United States

National Clinical Research, Inc ( Site 0044)

Richmond, Virginia, United States

Rainier Clinical Research Center ( Site 0013)

Renton, Washington, United States

CEDIC ( Site 0603)

CABA, Buenos Aires, Argentina

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

CABA, Buenos Aires, Argentina

Instituto de Investigaciones Clínicas Mar del Plata ( Site 0602)

Mar del Plata, Buenos Aires, Argentina

Instituto de Investigaciones Clinicas Zarate ( Site 0604)

Zárate, Buenos Aires, Argentina

Fundacion Estudios Clinicos ( Site 0601)

Rosario, Santa Fe Province, Argentina

Centro de Investigaciones Metabolicas CINME - Cardiology ( Site 0607)

CABA, Argentina

CIPREC ( Site 0600)

CABA, Argentina

Fundación Respirar ( Site 0606)

CABA, Argentina

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

Camperdown, New South Wales, Australia

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

Clayton, Victoria, Australia

Universidade Federal Do Ceara ( Site 0702)

Fortaleza, Ceará, Brazil

Instituto Dante Pazzanese de Cardiology ( Site 0701)

São Paulo, São Paulo, Brazil

Incor - Instituto do Coracao ( Site 0703)

São Paulo, Brazil

The Medical Arts Health Research Group ( Site 0506)

North Vancouver, British Columbia, Canada

Cambridge Cardiac Care Centre ( Site 0502)

Cambridge, Ontario, Canada

North York Diagnostic and Cardiac Centre ( Site 0505)

North York, Ontario, Canada

Ecogene-21 ( Site 0500)

Chicoutimi, Quebec, Canada

Institut de Cardiologie de Montreal ( Site 0504)

Montreal, Quebec, Canada

Diex Recherche Trois-Rivieres ( Site 0503)

Trois-Rivières, Quebec, Canada

Clinical Research Chile SpA ( Site 0800)

Valdivia, Los Ríos Region, Chile

CDIEM ( Site 0801)

Providencia, Region M. de Santiago, Chile

Pontificia Universidad Catolica de Chile-CICUC ( Site 0803)

Santiago, Region M. de Santiago, Chile

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

Beijing, Beijing Municipality, China

Beijing Friendship Hospital Affiliate of Capital University ( Site 6003)

Beijing, Beijing Municipality, China

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

Chongqing, Chongqing Municipality, China

Chongqing University Three Gorges Hospital ( Site 6021)

Chongqing, Chongqing Municipality, China

Guangdong Provincial People s Hospital ( Site 6004)

Guangzhou, Guangdong, China

Zhujiang Hospital ( Site 6029)

Guangzhou, Guangdong, China

Huizhou Municipal Central Hospital ( Site 6079)

Huizhou, Guangdong, China

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

Shenzhen, Guangdong, China

Jingzhou Central Hospital ( Site 6076)

Jingzhou, Hubei, China

Wuhan Fourth Hospital ( Site 6056)

Wuhan, Hubei, China

Hunan Provincial People's Hospital ( Site 6017)

Changsha, Hunan, China

Changzhou Second People's Hospital ( Site 6073)

Changzhou, Jiangsu, China

Northern Jiangsu People s Hospital ( Site 6008)

Yangzhou, Jiangsu, China

The Third Hospital of Nanchang - Fuhe ( Site 6078)

Nanchang, Jiangxi, China

Siping Central People's Hospital ( Site 6011)

Siping, Jilin, China

Xianyang Hospital of Yan'an University ( Site 6040)

Xianyang, Shaanxi, China

Chengdu Second Municipal People's Hospital ( Site 6032)

Chengdu, Sichuan, China

Lishui City People s Hospital ( Site 6002)

Lishui, Zhejiang, China

Fundación Centro de Investigación Clínica CIC ( Site 0904)

Medellín, Antioquia, Colombia

Ciensalud Ips S A S ( Site 0900)

Barranquilla, Atlántico, Colombia

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

Barranquilla, Atlántico, Colombia

Salud SURA Calle 100 ( Site 0905)

Bogotá, Cundinamarca, Colombia

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

Zipaquirá, Cundinamarca, Colombia

Fundación Valle del Lili ( Site 0903)

Cali, Valle del Cauca Department, Colombia

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

Brno, Brno-mesto, Czechia

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

Brno, Brno-mesto, Czechia

Institut Klinicke a Experimentalni Mediciny ( Site 3601)

Prague, Praha 4, Czechia

Meilahden tornisairaala - Meilahti Tower Hospital ( Site 1300)

Helsinki, Uusimaa, Finland

Hôpital Arnaud de Villeneuve - CHU Montpellier ( Site 5002)

Montpellier, Herault, France

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

Saint-Herblain, Loire-Atlantique, France

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

Bron, Rhone, France

Unterfrintroper Hausarztzentrum Klinische Forschung ( Site 1543)

Essen, North Rhine-Westphalia, Germany

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

Dresden, Saxony, Germany

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

Hohenmölsen, Saxony-Anhalt, Germany

Zentralklinik Bad Berka ( Site 1531)

Bad Berka, Thuringia, Germany

Velocity Clinical Research GmbH Berlin ( Site 1503)

Berlin, Germany

Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 1534)

Berlin, Germany

Queen Mary Hospital-Medical ( Site 3300)

Hksar, Hong Kong

Prince of Wales Hospital ( Site 3304)

Shatin, Hong Kong

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

Szeged, Csongrád megye, Hungary

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

Budapest, Hungary

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

Debrecen, Hungary

Hillel Yaffe Medical Center ( Site 1731)

Hadera, Israel

Rambam Health Care Campus ( Site 1739)

Haifa, Israel

Rambam Health Care Campus ( Site 1742)

Haifa, Israel

Shaare Zedek Medical Center ( Site 1735)

Jerusalem, Israel

Hadassah Medical Center ( Site 1732)

Jerusalem, Israel

Hadassah Medical Center ( Site 1741)

Jerusalem, Israel

Hadassah Medical Center-Heart Institute ( Site 1734)

Jerusalem, Israel

Meir Medical Center. ( Site 1737)

Kfar Saba, Israel

Rabin Medical Center ( Site 1738)

Petah Tikva, Israel

Rabin Medical Center ( Site 1740)

Petah Tikva, Israel

Sheba Medical Center ( Site 1733)

Ramat Gan, Israel

Clalit Health Services - Sakhnin Community Clinic ( Site 1730)

Sakhnin, Israel

Yitzhak Shamir Medical Center. ( Site 1736)

Ẕerifin, Israel

Fondazione Policlinico Tor Vergata ( Site 1809)

Rome, Lazio, Italy

Centro Cardiologico Monzino ( Site 1804)

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)

Kitakyushu, 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

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

Mitsukoshi Health and Welfare Foundation ( Site 3521)

Tokyo, Japan

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

Guadalajara, Jalisco, Mexico

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

Mexico City, Mexico City, Mexico

Radboudumc-internal medicine ( Site 1952)

Nijmegen, Gelderland, Netherlands

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

Amsterdam, North Holland, Netherlands

Dijklander Ziekenhuis ( Site 1953)

Hoorn, North Holland, Netherlands

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

Utrecht, Netherlands

Pacific Clinical Research Network - Rotorua ( Site 2902)

Rotorua, Bay of Plenty, New Zealand

New Zealand Clinical Research (Christchurch) ( Site 2901)

Christchurch, Canterbury, New Zealand

Nordlandssykehuset ( Site 2041)

Bodø, Nordland, Norway

Oslo Universitetssykehus Aker-Lipidklinikken ( Site 2040)

Oslo, Norway

Changi General Hospital ( Site 3211)

Singapore, Central Singapore, Singapore

IATROS International ( Site 2204)

Bloemfontein, Free State, South Africa

Charlotte Maxeke Johannesburg Academic Hospital ( Site 2202)

Johannesburg, Gauteng, South Africa

Soweto Clinical Trials Centre ( Site 2203)

Soweto, Gauteng, South Africa

TREAD Research ( Site 2201)

Cape Town, Western Cape, South Africa

Tiervlei Trial Centre ( Site 2205)

Cape Town, Western Cape, South Africa

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

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-Cardiology ( 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 de la Victoria-UGC Endocrinologia y nutricion ( Site 2358)

Málaga, Andalusia, Spain

EBA CENTELLES ( Site 2319)

Centelles, Barcelona, Spain

Hospital Universitari Vall d'Hebron ( Site 2362)

Barcelona, Catalonia, Spain

Hospital de Figueres ( Site 2361)

Figueres, Gerona, Spain

Hospital Abente y Lago ( Site 2356)

A Coruña, La Coruna, Spain

Hospital San Rafael de Coruna ( Site 2363)

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 ( 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 Universitari Sant Joan de Reus ( Site 2329)

Reus, Tarragona, Spain

HOSPITAL CLINICO DE VALENCIA-CARDIOLOGY ( Site 2321)

Valencia, Valenciana, Comunitat, Spain

EAP Sardenya ( Site 2357)

Barcelona, Spain

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

Madrid, Spain

Hospital Universitario Virgen Macarena-Cardiology ( Site 2352)

Seville, Spain

Mackay Memorial Hospital -Tamsui Branch ( Site 3109)

New Taipei City, New Taipei, Taiwan

Chi Mei Medical Center ( Site 3104)

Tainan, Tainan, Taiwan

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

Taipei City, Taipei, Taiwan

Changhua Christian Hospital ( Site 3101)

Changhua, Taiwan

Chang Gung Memorial Hospital at Kaohsiung ( Site 3102)

Kaohsiung City, Taiwan

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

Tainan, Taiwan

National Taiwan University Hospital ( Site 3100)

Taipei, Taiwan

Taipei Medical University Hospital ( Site 3108)

Taipei, Taiwan

Taipei Veterans General Hospital ( Site 3106)

Taipei, Taiwan

Chang Gung Medical Foundation-Linkou Branch ( Site 3105)

Taoyuan District, Taiwan

Ege Universitesi Hastanesi-Cardilogy Department ( Site 2502)

Bornova, İzmir, Turkey (Türkiye)

Hacettepe Universite Hastaneleri ( Site 2500)

Ankara, 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 ( Site 2522)

Kayseri, Turkey (Türkiye)

Kocaeli Üniversitesi-Cardiology ( Site 2516)

Kocaeli, Turkey (Türkiye)

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

London, England, United Kingdom

Royal Free Hospital ( Site 4000)

London, England, United Kingdom