Hypercholesterolemia Clinical Trial
Official title:
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-0616 in Adults With Hypercholesterolemia
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.
| Status | 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 |
| 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 | 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 | Chongqing University Three Gorges Hospital ( Site 3321) | Wanzhou | Chongqing |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme LLC |
United States, Argentina, China, Colombia, Germany, Israel, Italy, Japan, Korea, Republic of, Mexico, South Africa, Spain, Taiwan, Turkey,
| 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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