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COMPLETED
NCT05952856
PHASE3

A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-013) CORALreef Lipids

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

The goal of this study is to evaluate the efficacy, safety, and tolerability of enlicitide decanoate in adult participants with hypercholesterolemia. The primary hypothesis is that enlicitide decanoate is superior to placebo on mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24.

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-0616 in Adults With Hypercholesterolemia

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2912

Start Date

2023-08-10

Completion Date

2025-07-28

Last Updated

2026-09-24

Healthy Volunteers

No

Interventions

DRUG

Enlicitide Decanoate

Oral tablet

DRUG

Placebo

Oral tablet

Locations (168)

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

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

Sheba Medical Center ( Site 1708)

Ramat Gan, 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, 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, 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)