AzTrials
AzTrials

HypercholesterolemiaPhase 3NCT06492291

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 study testing Enlicitide Decanoate in people with Hypercholesterolemia, run by Merck Sharp & Dohme LLC at 222 sites in 28 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypercholesterolemia
What is being tested?
Enlicitide Decanoate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,000 participants
Where
222 sitesin 28 countries
Study dates
5 Aug 2024to 13 Oct 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

222 sites in 28 countries.

222 sites in 28 countries

United States52 sites

  • New Mexico Clinical Research & Osteoporosis Center ( Site 0043)

    Albuquerque, New Mexico, 87106

  • Velocity Clinical Research, Anderson ( Site 0015)

    Anderson, South Carolina, 29621

  • National Heart Institute-Research ( Site 0029)

    Beverly Hills, California, 90211

  • Excel Medical Clinical Trials ( Site 0010)

    Boca Raton, Florida, 33434

  • Velocity Clinical Research, Covington ( Site 0026)

    Covington, Louisiana, 70433

  • Velocity Clinical Research, Dallas ( Site 0028)

    Dallas, Texas, 75230

  • Alliance for Multispecialty Research, LLC ( Site 0027)

    Daphne, Alabama, 36526

  • Alliance for Multispecialty Research, LLC ( Site 0037)

    Doral, Florida, 33172

  • altoona center for clinical research ( Site 0024)

    Duncansville, Pennsylvania, 16635

  • Velocity Clinical Research, Syracuse ( Site 0014)

    East Syracuse, New York, 13057

  • Synexus Clinical Research US - Evansville ( Site 0005)

    Evansville, Indiana, 47714

  • Lillestol Research ( Site 0030)

    Fargo, North Dakota, 58104

  • Healthcare Research Network - Chicago ( Site 0051)

    Flossmoor, Illinois, 60422

  • G&L Research ( Site 0035)

    Foley, Alabama, 36535

  • Piedmont Research Partners ( Site 0045)

    Fort Mill, South Carolina, 29707

  • Alliance for Multispecialty Research, LLC ( Site 0056)

    Fort Myers, Florida, 33912

  • Velocity Clinical Research, Gulfport ( Site 0032)

    Gulfport, Mississippi, 39503

  • Velocity Clinical Research, Hallandale Beach ( Site 0053)

    Hallandale, Florida, 33009

  • Healthcare Research Network - St. Louis ( Site 0040)

    Hazelwood, Missouri, 63042

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

    Houston, Texas, 77030

  • Midwest Institute For Clinical Research ( Site 0052)

    Indianapolis, Indiana, 46260

  • Jacksonville Center for Clinical Research ( Site 0025)

    Jacksonville, Florida, 32216

  • Holston Medical Group ( Site 0034)

    Kingsport, Tennessee, 37660

  • Alliance for Multispecialty Research, LLC ( Site 0050)

    Knoxville, Tennessee, 37920

  • Jubilee Clinical Research ( Site 0049)

    Las Vegas, Nevada, 89106

  • AB Clinical Trials ( Site 0002)

    Las Vegas, Nevada, 89119

  • Alliance for Multispecialty Research, LLC ( Site 0001)

    Lexington, Kentucky, 40509

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

    Lincoln, Nebraska, 68510

  • L-MARC Research Center ( Site 0011)

    Louisville, Kentucky, 40213

  • East Coast Institute for Research, LLC ( Site 0020)

    Macon, Georgia, 31210

  • Manassas Clinical Research Center ( Site 0007)

    Manassas, Virginia, 20110

  • South Broward Research ( Site 0012)

    Miramar, Florida, 33027

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

    New York, New York, 10029

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

    Newport News, Virginia, 23606

  • Alliance for Multispecialty Research, LLC ( Site 0008)

    Norfolk, Virginia, 23502

  • Coastal Carolina Research Center ( Site 0055)

    North Charleston, South Carolina, 29405

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

    Phoenix, Arizona, 85020

  • Progressive Medical Research ( Site 0033)

    Port Orange, Florida, 32127

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

    Rapid City, South Dakota, 57701

  • Rainier Clinical Research Center ( Site 0013)

    Renton, Washington, 98057

  • National Clinical Research, Inc ( Site 0044)

    Richmond, Virginia, 23294

  • Velocity Clinical Research Rockville ( Site 0022)

    Rockville, Maryland, 20854

  • Clinical Trials Research ( Site 0054)

    Sacramento, California, 95821

  • Synexus Clinical Research US, Inc. ( Site 0003)

    Salt Lake City, Utah, 84106

  • Clinical Trials of Texas, LLC ( Site 0016)

    San Antonio, Texas, 78229

  • Velocity Clinical Research, Banning ( Site 0023)

    San Bernardino, California, 92408

  • Clinical Research Trials of Florida ( Site 0006)

    Tampa, Florida, 33607

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

    Troy, Michigan, 48098

  • Emerson Clinical Research Institute ( Site 0017)

    Washington D.C., District of Columbia, 20009

  • Velocity Clinical Research, Salt Lake City ( Site 0041)

    West Jordan, Utah, 84088

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

    Winter Park, Florida, 32789

  • Cardiology Consultants of Philadelphia Yardley ( Site 0021)

    Yardley, Pennsylvania, 19067

Other trials in United States

Japan23 sites

  • Teramoto Medical and Dental Clinic ( Site 3507)

    Bunkyo-ku, Tokyo, 113-0033

  • Tokyo-Eki Center-building Clinic ( Site 3505)

    Chuo-ku, Tokyo, 103-0027

  • Fukuwa Clinic ( Site 3504)

    Chuo-ku, Tokyo, 104-0031

  • Medical Corporation Hakuaikai Wellness Tenjin Clinic ( Site 3520)

    Fukuoka, 810-0001

  • Hiroshima City Hiroshima Citizens Hospital ( Site 3518)

    Hiroshima, 730-8518

  • Saitama Medical University Hospital ( Site 3506)

    Iruma, Saitama, 350-0495

  • Rinku General Medical Center ( Site 3503)

    Izumisano, Osaka, 598-8577

  • National Hospital Organization Kanazawa Medical Center ( Site 3508)

    Kanazawa, Ishikawa-ken, 920-8650

  • Shiraiwa Medical Clinic ( Site 3514)

    Kashihara, Osaka, 582-0005

  • Kato Clinic of Internal Medicine ( Site 3509)

    Katsushika-ku, Tokyo, 125-0054

  • Hirohata Naika Clinic ( Site 3513)

    Kitakyushu, Fukuoka, 807-0857

  • Kanno Naika ( Site 3511)

    Mitaka, Tokyo, 181-0013

  • Hirano Medical Clinic ( Site 3522)

    Morioka, Iwate, 020-0132

  • Nakakinen clinic ( Site 3510)

    Naka, Ibaraki, 311-0113

  • Sugawara Clinic ( Site 3519)

    Nerima-ku, Tokyo, 177-0041

  • Shin Clinic ( Site 3517)

    Ōta-ku, Tokyo, 144-0051

  • Shirai Healthcare Clinic Izumichuou ( Site 3527)

    Sendai, Miyagi, 981-3133

  • Medical Corporation Heishinkai ToCROM Clinic ( Site 3502)

    Shinjuku-ku, Tokyo, 160-0008

  • Medical Corporation Heishinkai OCROM Clinic ( Site 3501)

    Suita-shi, Osaka, 565-0853

  • Teikyo University Hospital ( Site 3500)

    tabashi City, Tokyo, 173-8606

  • Mishuku Hospital ( Site 3524)

    Tokyo, 153-0051

  • Mitsukoshi Health and Welfare Foundation ( Site 3521)

    Tokyo, 160-0023

  • Noritake Clinic ( Site 3512)

    Ushiku, Ibaraki, 300-1207

Other trials in Japan

China18 sites

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

    Beijing, Beijing Municipality, 100029

  • Beijing Friendship Hospital Affiliate of Capital University ( Site 6003)

    Beijing, Beijing Municipality, 100050

  • Hunan Provincial People's Hospital ( Site 6017)

    Changsha, Hunan, 400000

  • Changzhou Second People's Hospital ( Site 6073)

    Changzhou, Jiangsu, 213000

  • Chengdu Second Municipal People's Hospital ( Site 6032)

    Chengdu, Sichuan, 610021

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

    Chongqing, Chongqing Municipality, 400072

  • Chongqing University Three Gorges Hospital ( Site 6021)

    Chongqing, Chongqing Municipality, 404100

  • Guangdong Provincial People s Hospital ( Site 6004)

    Guangzhou, Guangdong, 510080

  • Zhujiang Hospital ( Site 6029)

    Guangzhou, Guangdong, 510280

  • Huizhou Municipal Central Hospital ( Site 6079)

    Huizhou, Guangdong, 516001

  • Jingzhou Central Hospital ( Site 6076)

    Jingzhou, Hubei, 434036

  • Lishui City People s Hospital ( Site 6002)

    Lishui, Zhejiang, 323000

  • The Third Hospital of Nanchang - Fuhe ( Site 6078)

    Nanchang, Jiangxi, 330003

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

    Shenzhen, Guangdong, 518053

  • Siping Central People's Hospital ( Site 6011)

    Siping, Jilin, 136000

  • Wuhan Fourth Hospital ( Site 6056)

    Wuhan, Hubei, 430030

  • Xianyang Hospital of Yan'an University ( Site 6040)

    Xianyang, Shaanxi, 712000

  • Northern Jiangsu People s Hospital ( Site 6008)

    Yangzhou, Jiangsu, 225001

Other trials in China

South Korea15 sites

  • Dong-A University Hospital-Cardiology ( Site 3013)

    Busan, Pusan-Kwangyokshi, 49201

  • Pusan National University Hospital-Internal Medicine ( Site 3012)

    Busan, Pusan-Kwangyokshi, 49241

  • Chungbuk National University Hospital ( Site 3011)

    Cheongju-si, North Chungcheong, 28644

  • Keimyung University Dongsan Hospital CRC room 1 ( Site 3003)

    Daegu, Taegu-Kwangyokshi, 42601

  • Chonnam National University Hospital ( Site 3014)

    Gwangju, Kwangju-Kwangyokshi, 61469

  • Inje University Haeundae Paik Hospital ( Site 3010)

    Haeundae-gu, Pusan-Kwangyokshi, 48108

  • Seoul National University Bundang Hospital ( Site 3005)

    Seongnam, Kyonggi-do, 13620

  • Seoul National University Hospital ( Site 3001)

    Seoul, 03080

  • Kangbuk Samsung Hospital ( Site 3009)

    Seoul, 03181

  • Severance Hospital, Yonsei University Health System ( Site 3002)

    Seoul, 03722

  • Asan Medical Center ( Site 3004)

    Seoul, 05505

  • Samsung Medical Center-cardiology ( Site 3000)

    Seoul, 06351

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

    Seoul, 06591

  • Ajou University Hospital ( Site 3006)

    Suwon, Kyonggi-do, 16499

  • Wonju Severance Christian Hospital ( Site 3008)

    Wŏnju, Kang-won-do, 26426

Other trials in South Korea

Spain15 sites

  • Hospital Abente y Lago ( Site 2356)

    A Coruña, La Coruna, 15001

  • Hospital San Rafael de Coruna ( Site 2363)

    A Coruña, La Coruna, 15006

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

    Alcorcón, Madrid, Comunidad de, 28922

  • Hospital Universitari Vall d'Hebron ( Site 2362)

    Barcelona, Catalonia, 08035

  • EAP Sardenya ( Site 2357)

    Barcelona, 08025

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

    Castilleja de la Cuesta, Sevilla, 41950

  • EBA CENTELLES ( Site 2319)

    Centelles, Barcelona, 08540

  • Hospital de Figueres ( Site 2361)

    Figueres, Gerona, 17600

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

    Madrid, 28041

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

    Málaga, Andalusia, 29010

  • HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 2344)

    Pozuelo de Alarcón, Madrid, 28223

  • Hospital Universitari Sant Joan de Reus ( Site 2329)

    Reus, Tarragona, 43204

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

    Santiago de Compostela, La Coruna, 15706

  • Hospital Universitario Virgen Macarena-Cardiology ( Site 2352)

    Seville, 41009

  • HOSPITAL CLINICO DE VALENCIA-CARDIOLOGY ( Site 2321)

    Valencia, Valenciana, Comunitat, 46010

Other trials in Spain

Israel13 sites

  • Hillel Yaffe Medical Center ( Site 1731)

    Hadera, 3810101

  • Rambam Health Care Campus ( Site 1739)

    Haifa, 3109601

  • Rambam Health Care Campus ( Site 1742)

    Haifa, 3109601

  • Shaare Zedek Medical Center ( Site 1735)

    Jerusalem, 9103102

  • Hadassah Medical Center ( Site 1732)

    Jerusalem, 9112001

  • Hadassah Medical Center ( Site 1741)

    Jerusalem, 9112001

  • Hadassah Medical Center-Heart Institute ( Site 1734)

    Jerusalem, 9112001

  • Meir Medical Center. ( Site 1737)

    Kfar Saba, 4428164

  • Rabin Medical Center ( Site 1738)

    Petah Tikva, 4941492

  • Rabin Medical Center ( Site 1740)

    Petah Tikva, 4941492

  • Sheba Medical Center ( Site 1733)

    Ramat Gan, 5265601

  • Clalit Health Services - Sakhnin Community Clinic ( Site 1730)

    Sakhnin, 3081000

  • Yitzhak Shamir Medical Center. ( Site 1736)

    Tsrifin, 7033001

Other trials in Israel

Taiwan10 sites

  • Changhua Christian Hospital ( Site 3101)

    Changhua, 50006

  • Chang Gung Memorial Hospital at Kaohsiung ( Site 3102)

    Kaohsiung City, 83301

  • Mackay Memorial Hospital -Tamsui Branch ( Site 3109)

    New Taipei City, New Taipei, 251

  • Chi Mei Medical Center ( Site 3104)

    Tainan, Tainan, 71004

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

    Tainan, 704

  • National Taiwan University Hospital ( Site 3100)

    Taipei, 10002

  • Taipei Medical University Hospital ( Site 3108)

    Taipei, 110301

  • Taipei Veterans General Hospital ( Site 3106)

    Taipei, 112

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

    Taipei City, Taipei, 111

  • Chang Gung Medical Foundation-Linkou Branch ( Site 3105)

    Taoyuan, 33305

Other trials in Taiwan

Argentina8 sites

  • CEDIC ( Site 0603)

    CABA, Buenos Aires, C1060ABN

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

    CABA, Buenos Aires, C1425AGC

  • Centro de Investigaciones Metabolicas CINME - Cardiology ( Site 0607)

    CABA, C1056ABI

  • CIPREC ( Site 0600)

    CABA, C1061AAS

  • Fundación Respirar ( Site 0606)

    CABA, C1426ABP

  • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0602)

    Mar del Plata, Buenos Aires, B7600FZO

  • Fundacion Estudios Clinicos ( Site 0601)

    Rosario, Santa Fe Province, S2000DEJ

  • Instituto de Investigaciones Clinicas Zarate ( Site 0604)

    Zárate, Buenos Aires, B2800DGH

Other trials in Argentina

Canada6 sites

  • Cambridge Cardiac Care Centre ( Site 0502)

    Cambridge, Ontario, N1R 6V6

  • Ecogene-21 ( Site 0500)

    Chicoutimi, Quebec, G7H 7K9

  • Institut de Cardiologie de Montreal ( Site 0504)

    Montreal, Quebec, H1T 1C8

  • The Medical Arts Health Research Group ( Site 0506)

    North Vancouver, British Columbia, V7M 2H4

  • North York Diagnostic and Cardiac Centre ( Site 0505)

    North York, Ontario, M6B 3H7

  • Diex Recherche Trois-Rivieres ( Site 0503)

    Trois-Rivières, Quebec, G9A 4P3

Other trials in Canada

Colombia6 sites

  • Ciensalud Ips S A S ( Site 0900)

    Barranquilla, Atlántico, 08001

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

    Barranquilla, Atlántico, 080020

  • Salud SURA Calle 100 ( Site 0905)

    Bogotá, Cundinamarca, 110231

  • Fundación Valle del Lili ( Site 0903)

    Cali, Valle del Cauca Department, 760032

  • Fundación Centro de Investigación Clínica CIC ( Site 0904)

    Medellín, Antioquia, 050021

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

    Zipaquirá, Cundinamarca, 250252

Other trials in Colombia

Germany6 sites

  • Zentralklinik Bad Berka ( Site 1531)

    Bad Berka, Thuringia, 99437

  • Velocity Clinical Research GmbH Berlin ( Site 1503)

    Berlin, 10787

  • Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 1534)

    Berlin, 12203

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

    Dresden, Saxony, 01307

  • Unterfrintroper Hausarztzentrum Klinische Forschung ( Site 1543)

    Essen, North Rhine-Westphalia, 45359

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

    Hohenmölsen, Saxony-Anhalt, 06679

Other trials in Germany

South Africa6 sites

  • IATROS International ( Site 2204)

    Bloemfontein, Free State, 9301

  • TREAD Research ( Site 2201)

    Cape Town, Western Cape, 7500

  • Tiervlei Trial Centre ( Site 2205)

    Cape Town, Western Cape, 7530

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

    Cape Town, Western Cape, 7925

  • Charlotte Maxeke Johannesburg Academic Hospital ( Site 2202)

    Johannesburg, Gauteng, 2193

  • Soweto Clinical Trials Centre ( Site 2203)

    Soweto, Gauteng, 1818

Other trials in South Africa

Turkey (Türkiye)6 sites

  • Hacettepe Universite Hastaneleri ( Site 2500)

    Ankara, 06230

  • Ankara Bilkent Şehir Hastanesi-cardiology ( Site 2501)

    Ankara, 06800

  • Ege Universitesi Hastanesi-Cardilogy Department ( Site 2502)

    Bornova, İzmir, 35100

  • Eskisehir Osmangazi University-Cardiology ( Site 2510)

    Eskişehir, 26480

  • Erciyes Universitesi Tıp Fakultesi Hastaneleri ( Site 2522)

    Kayseri, 38039

  • Kocaeli Üniversitesi-Cardiology ( Site 2516)

    Kocaeli, 41380

Other trials in Turkey (Türkiye)

Italy5 sites

  • Azienda Ospedaliera Garibaldi ( Site 1810)

    Catania, 95122

  • Centro Cardiologico Monzino ( Site 1804)

    Milan, Milano, 20138

  • Fondazione Policlinico Tor Vergata ( Site 1809)

    Rome, Lazio, 00133

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

    Rome, Roma, 00189

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

    Turin, Piedmont, 10126

Other trials in Italy

Netherlands4 sites

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

    Amsterdam, North Holland, 1105 AZ

  • Dijklander Ziekenhuis ( Site 1953)

    Hoorn, North Holland, 1624 NP

  • Radboudumc-internal medicine ( Site 1952)

    Nijmegen, Gelderland, 6525 GA

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

    Utrecht, 3584 CX

Other trials in Netherlands

Brazil3 sites

  • Universidade Federal Do Ceara ( Site 0702)

    Fortaleza, Ceará, 60430270

  • Instituto Dante Pazzanese de Cardiology ( Site 0701)

    São Paulo, São Paulo, 04012-909

  • Incor - Instituto do Coracao ( Site 0703)

    São Paulo, 05403-900

Other trials in Brazil

Chile3 sites

  • CDIEM ( Site 0801)

    Providencia, Region M. de Santiago, 7500859

  • Pontificia Universidad Catolica de Chile-CICUC ( Site 0803)

    Santiago, Region M. de Santiago, 8330034

  • Clinical Research Chile SpA ( Site 0800)

    Valdivia, Los Ríos Region, 5110683

Other trials in Chile

Czechia3 sites

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

    Brno, Brno-mesto, 602 00

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

    Brno, Brno-mesto, 625 00

  • Institut Klinicke a Experimentalni Mediciny ( Site 3601)

    Prague, Praha 4, 14021

Other trials in Czechia

France3 sites

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

    Bron, Rhone, 69677

  • Hôpital Arnaud de Villeneuve - CHU Montpellier ( Site 5002)

    Montpellier, Herault, 34090

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

    Saint-Herblain, Loire-Atlantique, 44800

Other trials in France

Hungary3 sites

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

    Budapest, 1122

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

    Debrecen, 4032

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

    Szeged, Csongrád megye, 6725

Other trials in Hungary

Australia2 sites

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

    Camperdown, New South Wales, 2050

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

    Clayton, Victoria, 3168

Other trials in Australia

Hong Kong2 sites

  • Queen Mary Hospital-Medical ( Site 3300)

    Hksar

  • Prince of Wales Hospital ( Site 3304)

    Shatin

Other trials in Hong Kong

Mexico2 sites

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

    Guadalajara, Jalisco, 44600

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

    Mexico City, Mexico City, 14080

Other trials in Mexico

New Zealand2 sites

  • New Zealand Clinical Research (Christchurch) ( Site 2901)

    Christchurch, Canterbury, 8011

  • Pacific Clinical Research Network - Rotorua ( Site 2902)

    Rotorua, Bay of Plenty, 3010

Other trials in New Zealand

Norway2 sites

  • Nordlandssykehuset ( Site 2041)

    Bodø, Nordland, 8005

  • Oslo Universitetssykehus Aker-Lipidklinikken ( Site 2040)

    Oslo, 0316

Other trials in Norway

United Kingdom2 sites

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

    London, England, EC1M 6BQ

  • Royal Free Hospital ( Site 4000)

    London, England, NW3 2QG

Other trials in United Kingdom

Finland1 site

  • Meilahden tornisairaala - Meilahti Tower Hospital ( Site 1300)

    Helsinki, Uusimaa, 00290

Other trials in Finland

Singapore1 site

  • Changi General Hospital ( Site 3211)

    Singapore, Central Singapore, 529889

Other trials in Singapore

About this study

Official title: 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).

Being tested
Enlicitide Decanoate
Medical subject headings
Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Enlicitide DecanoateDrug

    Also called MK-0616, Enlicitide

    Oral tablet

Study groups in NCT06492291
Study groupRoleWhat they receive
Enlicitide DecanoateExperimentalParticipants will receive 20 mg of enlicitide decanoate orally once daily (QD)
Receives: Drug: Enlicitide Decanoate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to approximately 3 years

  2. 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.

    Measured: Up to approximately 3 years

Secondary outcomes (6)

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2024
  2. Study start5 Aug 2024
  3. Primary completion13 Oct 2028 (estimated)
  4. Study completion13 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06492291
Sponsor's protocol ID
0616-019
Other IDs
2023-504922-20-00, U1111-1290-3950, jRCT2051240110, MK-0616-019, 2023
Status last verified
Oct 2025
First submitted
1 Jul 2024
Last updated
7 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Enlicitide Decanoate in people with Hypercholesterolemia, run by Merck Sharp & Dohme LLC at 222 sites in 28 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 222 sites in United States, Japan, China, South Korea, Spain and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with one or more adverse events (AEs) (time frame: Up to approximately 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06492291.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.

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