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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05952856
Other study ID # 0616-013
Secondary ID MK-0616-0132022-
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date August 10, 2023
Est. completion date September 24, 2025

Study information

Verified date May 2024
Source Merck Sharp & Dohme LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this study is to evaluate the efficacy, safety, and tolerability of MK-0616 in adult participants with hypercholesterolemia. The primary hypothesis is that MK-0616 is superior to placebo on mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 2760
Est. completion date September 24, 2025
Est. primary completion date September 15, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Has a history of a major atherosclerotic cardiovascular disease (ASCVD) event and LDL-C =55 mg/dL OR, if no history of a major ASCVD event, has intermediate to high risk for development of a first major ASCVD event and LDL-C =70 mg/dL. - Is treated with a moderate- or high-intensity statin OR is treated with low-intensity statin with documentation of intolerance to a moderate or high-intensity statin OR is not receiving statins with documentation of statin intolerance - If on any lipid-lowering therapies (LLTs), should be on a stable dose with no planned medication change. Exclusion Criteria: - Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria, compound heterozygous FH, or double heterozygous FH - Has a history of heart failure or heart failure hospitalization within 3 months before first study visit - Is undergoing or previously underwent an LDL-C apheresis program within 3 months before first study visit or plans to initiate an LDL-C apheresis program - Was previously treated/is being treated with certain other cholesterol lowering medications, including protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors without adequate washout

Study Design


Intervention

Drug:
MK-0616
Oral tablet
Placebo
Oral tablet

Locations

Country Name City State
Argentina Fundación Respirar ( Site 0610) Buenos Aires
Argentina CEDIC ( Site 0612) Caba Buenos Aires
Argentina Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0604) Ciudad Autonoma de Buenos Aires Caba
Argentina Centro de Investigaciones Metabólicas (CINME)-Cardiology ( Site 0620) Ciudad Autónoma de Buenos Aires 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
China Beijing Anzhen Hospital, Capital Medical University-Cardiovascular ( Site 3300) Beijing Beijing
China Beijing Friendship Hospital Affiliate of Capital University-Cardiology ( Site 3303) Beijing Beijing
China Hunan Provincial People's Hospital-Cardiology ( Site 3317) ChangSha Hunan
China Changzhou Second People's Hospital-Cardiology ( Site 3373) Changzhou Jiangsu
China Chengdu Second Municipal People's Hospital ( Site 3332) Chengdu Sichuan
China 2nd Affiliated Hospital Chongqing Medical Universi ( Site 3320) Chongqing Chongqing
China Chongqing University Three Gorges Hospital ( Site 3321) Chongqing Chongqing
China Guangdong Provincial People's Hospital-Cardiology ( Site 3304) Guangzhou Guangdong
China Zhujiang Hospital ( Site 3329) Guangzhou Guangdong
China Huizhou Municipal Central Hospital ( Site 3379) Huizhou Guangdong
China Jingzhou Central Hospital-Cardiology ( Site 3376) Jingzhou Hubei
China People's Hospital of Lishui City-department of cardiovascular ( Site 3302) Lishui Zhejiang
China The Third Hospital of Nanchang - Fuhe-cardiology ( Site 3378) Nanchang Jiangxi
China The University of Hong Kong-Shenzhen Hospital-Cardiovascular department ( Site 3318) Shenzhen Guangdong
China Siping Central People's Hospital-Cardiovascular Department ( Site 3311) Siping Jilin
China Wuhan Fourth Hospital ( Site 3356) Wuhan Hubei
China Xianyang Hospital of Yan'an University ( Site 3340) Xianyang Shaanxi
China Northern Jiangsu People's Hospital ( Site 3308) Yangzhou Jiangsu
Colombia Ciensalud Ips S A S ( Site 0903) Barranquilla Atlantico
Colombia Clinica de la Costa S.A.S. ( Site 0902) Barranquilla Atlantico
Colombia Salud SURA Calle 100 ( Site 0918) Bogotá Cundinamarca
Colombia Fundación Valle del Lili ( Site 0904) Cali Valle Del Cauca
Colombia Fundación Centro de Investigación Clínica CIC ( Site 0906) Medellín Antioquia
Colombia Healthy Medical Center S.A.S ( Site 0913) Zipaquira Cundinamarca
Germany Zentralklinik Bad Berka ( Site 1530) Bad Berka Thuringen
Germany Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 1533) Berlin
Germany Velocity Clinical Research GmbH Berlin ( Site 1502) Berlin
Germany Universitaetsklinikum Carl Gustav Carus Dresden-Universitätsstudienzentrum für Stoffwechselerkranku Dresden Sachsen
Germany Unterfrintroper Hausarztzentrum Klinische Forschung ( Site 1542) Essen Nordrhein-Westfalen
Germany Hausarzt- und Diabetologische Schwerpunktpraxis Hohenmölsen - Weißenfels ( Site 1527) Hohenmölsen Sachsen-Anhalt
Israel Hillel Yaffe Medical Center ( Site 1705) Hadera
Israel Rambam Health Care Campus-internal department ( Site 1718) Haifa
Israel Hadassah Medical Center ( Site 1706) Jerusalem
Israel Hadassah Medical Center ( Site 1709) Jerusalem
Israel Shaare Zedek Medical Center ( Site 1710) 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) Zerifin
Italy Azienda Ospedaliera Garibaldi ( Site 1810) Catania
Italy ASST Grande Ospedale Metropolitano Niguarda-Unità Ricerche Cliniche della Cardiologia 4 ( Site 1811) Milan Milano
Italy Centro Cardiologico Monzino ( Site 1804) Milan Milano
Italy Azienda Ospedaliera Sant'Andrea-Department of Clinical and Molecular Medicine ( Site 1807) Rome Roma
Italy Fondazione Policlinico Tor Vergata ( Site 1809) Rome Lazio
Italy Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino ( Site 1801) Torino Piemonte
Japan Teramoto Medical and Dental Clinic ( Site 3507) Bunkyo-ku Tokyo
Japan Fukuwa Clinic ( Site 3504) Chuo-ku Tokyo
Japan Tokyo-Eki Center-building Clinic ( Site 3505) Chuo-ku Tokyo
Japan Medical Corporation Hakuaikai Wellness Tenjin Clinic ( Site 3520) Fukuoka
Japan Hiroshima City Hospital ( Site 3518) Hiroshima
Japan Saitama Medical University Hospital ( Site 3506) Iruma Saitama
Japan Teikyo University Hospital ( Site 3500) Itabashi-ku Tokyo
Japan Rinku General Medical Center ( Site 3503) Izumisano Osaka
Japan National Hospital Organization Kanazawa Medical Center ( Site 3508) Kanazawa Ishikawa
Japan Shiraiwa Medical Clinic ( Site 3514) Kashiwara Osaka
Japan Kato Clinic of Internal Medicine ( Site 3509) Katsushika-ku Tokyo
Japan Hirohata Naika Clinic ( Site 3513) Kitakyusyu-shi Fukuoka
Japan Kanno Naika ( Site 3511) Mitaka Tokyo
Japan Hirano Medical Clinic ( Site 3522) Morioka Iwate
Japan Nakakinen clinic ( Site 3510) Naka Ibaraki
Japan Sugawara Clinic ( Site 3519) Nerima-ku Tokyo
Japan Shin Clinic - Tokyo - Nishikamata ( Site 3517) Ota-ku Tokyo
Japan Shirai Healthcare Clinic Izumichuou ( Site 3527) Sendai Miyagi
Japan Heishinkai Medical Group ToCROM Clinic ( Site 3502) Shinjuku-ku Tokyo
Japan Mitsukoshi Health and Welfare Foundation ( Site 3521) Shinjuku-ku Tokyo
Japan Medical Corporation Heishinkai OCROM Clinic ( Site 3501) Suita-shi Osaka
Japan Mishuku Hospital ( Site 3524) Tokyo
Japan Noritake Clinic ( Site 3512) Ushiku Ibaraki
Korea, Republic of Dong-A University Hospital ( Site 3013) Busan Pusan-Kwangyokshi
Korea, Republic of Pusan National University Hospital-Internal Medicine ( Site 3012) Busan Pusan-Kwangyokshi
Korea, Republic of Chungbuk National University Hospital ( Site 3011) Cheongju-si Chungbuk
Korea, Republic of Keimyung University Dongsan Hospital ( Site 3003) Daegu Taegu-Kwangyokshi
Korea, Republic of Chonnam National University Hospital ( Site 3014) Gwangju-si Kwangju-Kwangyokshi
Korea, Republic of Inje University Haeundae Paik Hospital ( Site 3010) Haeundae-gu Pusan-Kwangyokshi
Korea, Republic of Seoul National University Bundang Hospital ( Site 3005) Seongnam Kyonggi-do
Korea, Republic of Asan Medical Center ( Site 3004) Seoul
Korea, Republic of Kangbuk Samsung Hospital ( Site 3009) Seoul
Korea, Republic of Samsung Medical Center-cardiology ( Site 3000) Seoul
Korea, Republic of Seoul National University Hospital ( Site 3001) Seoul
Korea, Republic of Severance Hospital, Yonsei University Health System ( Site 3002) Seoul
Korea, Republic of The Catholic Univ. of Korea Seoul St. Mary's Hospital-cardiology ( Site 3007) Seoul
Korea, Republic of Ajou University Hospital ( Site 3006) Suwon Kyonggi-do
Korea, Republic of Wonju Severance Christian Hospital ( Site 3008) Wonju Kang-won-do
Mexico Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 1071) Cdmx Distrito Federal
Mexico Instituto Jalisciense de Investigacion en Diabetes y Obesidad-Endocrinology ( Site 1057) Guadalajara Jalisco
South Africa Tiervlei Trial Centre-Clinical ( Site 2246) Bellville, Cape Town Western Cape
South Africa IATROS INTERNATIONAL ( Site 2247) Bloemfontein Free State
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 Charlotte Maxeke Johannesburg Academic Hospital-WCR-LIPIDS ( Site 2241) Johannesburg Gauteng
South Africa Soweto Clinical Trials Centre ( Site 2242) Johannesburg Gauteng
Spain Hospital Abente y Lago ( Site 2356) A Coruña La Coruna
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 EBA CENTELLES ( Site 2311) Centelles Cataluna
Spain Hospital Universitario 12 de Octubre-Internal Medicine. Unidad de Ensayos Clínicos ( Site 2319) Madrid
Spain HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-Endocrinologia y Nutrición ( Site 2344) Pozuelo de Alarcón Madrid
Spain CHUS - Hospital Clinico Universitario-Cardiology - Clinical Research Unit ( Site 2320) Santiago de Compostela La Coruna
Spain Hospital Universitario Virgen Macarena ( Site 2352) Sevilla Andalucia
Spain HOSPITAL CLINICO DE VALENCIA-CARDIOLOGY ( Site 2321) Valencia Valenciana, Comunitat
Taiwan Changhua Christian Hospital ( Site 3101) Changhua County Changhua
Taiwan Chang Gung Memorial Hospital at Kaohsiung ( Site 3102) Kaohsiung Niao Sung Dist Kaohsiung
Taiwan National Cheng Kung University Hospital-Internal Medicine ( Site 3107) Tainan
Taiwan Chi Mei Medical Center-Cardiology ( Site 3104) Tainan City 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
Turkey Hacettepe Universite Hastaneleri ( Site 2500) Altindag Ankara
Turkey Ankara Bilkent Sehir Hastanesi-cardiology ( Site 2501) Ankara
Turkey Ege Universitesi Hastanesi-Cardilogy Department ( Site 2502) Bornova Izmir
Turkey Eskisehir Osmangazi University-Cardiology ( Site 2510) Eskisehir
Turkey Erciyes Universitesi Tip Fakultesi Hastaneleri-endocrine ( Site 2522) Kayseri
Turkey Kocaeli Üniversitesi-Cardiology ( Site 2516) Kocaeli
United States New Mexico Clinical Research & Osteoporosis Center ( Site 0005) Albuquerque New Mexico
United States Velocity Clinical Research, Banning ( Site 0017) Banning California
United States National Heart Institute-Research ( Site 0087) Beverly Hills California
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 Velocity Clinical Research, Dallas ( Site 0114) Dallas Texas
United States Alliance for Multispecialty Research, LLC ( Site 0093) Daphne Alabama
United States altoona center for clinical research ( Site 0089) Duncansville Pennsylvania
United States Velocity Clinical Research, Syracuse ( Site 0021) East Syracuse New York
United States Synexus Clinical Research US - Evansville ( Site 0109) Evansville Indiana
United States Lillestol Research ( Site 0026) Fargo North Dakota
United States Healthcare Research Network - Chicago ( Site 0052) Flossmoor Illinois
United States G&L Research ( Site 0043) Foley Alabama
United States Piedmont Research Partners ( Site 0090) Fort Mill South Carolina
United States Alliance for Multispecialty Research, LLC ( Site 0094) Fort Myers Florida
United States Velocity Clinical Research, Greenville ( Site 0023) Greenville South Carolina
United States Velocity Clinical Research, Gulfport ( Site 0039) Gulfport Mississippi
United States Velocity Clinical Research, Hallandale Beach ( Site 0018) Hallandale Beach Florida
United States Healthcare Research Network - St. Louis ( Site 0054) Hazelwood Missouri
United States Center for Cardiometabolic Disease Prevention/Baylor College of Medicine ( Site 0111) Houston Texas
United States Midwest Institute For Clinical Research ( Site 0059) Indianapolis Indiana
United States Jacksonville Center for Clinical Research ( Site 0049) Jacksonville Florida
United States Holston Medical Group ( Site 0048) Kingsport Tennessee
United States Alliance for Multispecialty Research, LLC ( Site 0008) Knoxville Tennessee
United States AB Clinical Trials ( Site 0070) Las Vegas Nevada
United States Jubilee Clinical Research ( Site 0106) Las Vegas Nevada
United States Alliance for Multispecialty Research, LLC ( Site 0028) Lexington Kentucky
United States L-MARC Research Center ( Site 0001) Louisville Kentucky
United States East Coast Institute for Research, LLC ( Site 0033) Macon Georgia
United States Manassas Clinical Research Center ( Site 0007) Manassas Virginia
United States South Broward Research ( Site 0051) Miramar Florida
United States Icahn School of Medicine at Mount Sinai-Cardiology ( Site 0002) New York New York
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 Coastal Carolina Research Center ( Site 0006) North Charleston South Carolina
United States Synexus Clinical Research US, Inc.-Synexus Clinical Research US, Inc - Central Phoenix ( Site 0084) Phoenix Arizona
United States Monument Health Clinical Research, a department of Monument -Monument Health Clinical Research, a d Rapid City South Dakota
United States Rainier Clinical Research Center ( Site 0116) Renton Washington
United States National Clinical Research, Inc ( Site 0061) Richmond Virginia
United States Velocity Clinical Research Rockville ( Site 0082) Rockville Maryland
United States Clinical Trials Research ( Site 0115) Sacramento California
United States Synexus Clinical Research US, Inc. ( Site 0110) Salt Lake City Utah
United States Clinical Trials of Texas, LLC ( Site 0103) San Antonio Texas
United States Velocity Clinical Research, Slidell ( Site 0068) Slidell Louisiana
United States Centricity Research Suffolk Primary Care ( Site 0092) Suffolk Virginia
United States Clinical Research Trials of Florida ( Site 0063) Tampa Florida
United States Emerson Clinical Research Institute ( Site 0118) Washington District of Columbia
United States Velocity Clinical Research, Salt Lake City ( Site 0019) West Jordan Utah
United States Cardiology Consultants of Philadelphia Yardley ( Site 0097) Yardley Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Argentina,  China,  Colombia,  Germany,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  South Africa,  Spain,  Taiwan,  Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24 Blood samples will be collected at baseline and at Week 24 to assess mean percent change in LDL-C. Baseline and Week 24
Primary 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 ~60 weeks
Primary 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 ~52 weeks
Secondary Mean percent change from baseline in LDL-C at Week 52 Blood samples will be collected at baseline and at Week 52 to assess mean percent change in LDL-C. Baseline and Week 52
Secondary Mean percent change from baseline in non-high-density lipoprotein cholesterol (non-HDL-C) at Week 24 Blood samples will be collected at baseline and at Week 24 to assess mean percent change in non-HDL-C. Baseline and Week 24
Secondary Mean percent change from baseline in apolipoprotein B (ApoB) at Week 24 Blood samples will be collected at baseline and at Week 24 to assess mean percent change in ApoB. Baseline and Week 24
Secondary Percent change from baseline in lipoprotein(a) (Lp[a]) at Week 24 Blood samples will be collected at baseline and at Week 24 to assess percent change in Lp(a). Baseline and Week 24
Secondary Percentage of participants with LDL-C <70 mg/dL and =50% reduction from baseline at Week 24 Blood samples will be collected at baseline and at Week 24 to assess the percentage of participants who have LDL-C <70 mg/dL and =50% reduction from baseline. Baseline and Week 24
Secondary Percentage of participants with LDL-C <55 mg/dL and =50% reduction from baseline at Week 24 Blood samples will be collected at baseline and at Week 24 to assess the percentage of participants who have LDL-C <55 mg/dL and =50% reduction from baseline. Baseline and Week 24
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