Een studie van MK-0616 (orale PCSK9-remmer) bij volwassenen met hypercholesterolemie (MK-0616-013)
28 augustus 2026 bijgewerkt door: Merck Sharp & Dohme LLC
Een gerandomiseerde, dubbelblinde, placebogecontroleerde fase 3-studie om de werkzaamheid en veiligheid van MK-0616 bij volwassenen met hypercholesterolemie te evalueren
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.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
2912
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
-
CABA, Argentinië, C1056ABI
- Centro de Investigaciones Metabólicas (CINME)-Cardiology ( Site 0620)
-
-
Buenos Aires
-
CABA, Buenos Aires, Argentinië, C1060ABN
- CEDIC ( Site 0612)
-
Mar del Plata, Buenos Aires, Argentinië, B7600FZO
- Instituto de Investigaciones Clínicas Mar del Plata ( Site 0605)
-
Zárate, Buenos Aires, Argentinië, B2800DGH
- Instituto de Investigaciones Clinicas Zarate ( Site 0600)
-
-
Buenos Aires F.D.
-
Buenos Aires, Buenos Aires F.D., Argentinië, C1425AGC
- Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0604)
-
Buenos Aires, Buenos Aires F.D., Argentinië, C1426ABP
- Fundación Respirar ( Site 0610)
-
-
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, China, 100029
- Beijing Anzhen Hospital, Capital Medical University-Cardiovascular ( Site 3300)
-
Beijing, Beijing Municipality, China, 100050
- Beijing Friendship Hospital Affiliate of Capital University-Cardiology ( Site 3303)
-
-
Chongqing Municipality
-
Chongqing, Chongqing Municipality, China, 400072
- The Second Affiliated Hospital of Chongqing Medical University ( Site 3320)
-
Chongqing, Chongqing Municipality, China, 404000
- Chongqing University Three Gorges Hospital ( Site 3321)
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510080
- Guangdong Provincial People's Hospital-Cardiology ( Site 3304)
-
Guangzhou, Guangdong, China, 510280
- Zhujiang Hospital of Southern Medical University ( Site 3329)
-
Huizhou, Guangdong, China, 516001
- Huizhou Municipal Central Hospital ( Site 3379)
-
Shenzhen, Guangdong, China, 518053
- The University of Hong Kong-Shenzhen Hospital-Cardiovascular department ( Site 3318)
-
-
Hubei
-
Jingzhou, Hubei, China, 434036
- Jingzhou Central Hospital-Cardiology ( Site 3376)
-
Wuhan, Hubei, China, 430030
- Wuhan Fourth Hospital ( Site 3356)
-
-
Hunan
-
Changsha, Hunan, China, 410005
- Hunan Provincial People's Hospital-Cardiology ( Site 3317)
-
-
Jiangsu
-
Changzhou, Jiangsu, China, 213000
- Changzhou Second People's Hospital-Cardiology ( Site 3373)
-
Yangzhou, Jiangsu, China, 225001
- Northern Jiangsu People's Hospital ( Site 3308)
-
-
Jiangxi
-
Nanchang, Jiangxi, China, 330003
- The Third Hospital of Nanchang - Fuhe-cardiology ( Site 3378)
-
-
Jilin
-
Siping, Jilin, China, 136000
- Siping Central People's Hospital-Cardiovascular Department ( Site 3311)
-
-
Shaanxi
-
Xianyang, Shaanxi, China, 712000
- Xianyang Hospital of Yan'an University ( Site 3340)
-
-
Sichuan
-
Chengdu, Sichuan, China, 610021
- Chengdu Second Municipal People's Hospital ( Site 3332)
-
-
Zhejiang
-
Lishui, Zhejiang, China, 323000
- People's Hospital of Lishui City-department of cardiovascular ( Site 3302)
-
-
-
-
Antioquia
-
Medellín, Antioquia, Colombia, 050021
- Fundación Centro de Investigación Clínica CIC ( Site 0906)
-
-
Atlántico
-
Barranquilla, Atlántico, Colombia, 08001
- Ciensalud Ips S A S ( Site 0903)
-
Barranquilla, Atlántico, Colombia, 080020
- Clinica de la Costa S.A.S. ( Site 0902)
-
-
Cundinamarca
-
Bogotá, Cundinamarca, Colombia, 110231
- Salud SURA Calle 100 ( Site 0918)
-
Zipaquirá, Cundinamarca, Colombia, 250252
- Healthy Medical Center S.A.S ( Site 0913)
-
-
Valle del Cauca Department
-
Cali, Valle del Cauca Department, Colombia, 760032
- Fundación Valle del Lili ( Site 0904)
-
-
-
-
-
Berlin, Duitsland, 10787
- Velocity Clinical Research GmbH Berlin ( Site 1502)
-
Berlin, Duitsland, 12203
- Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 1533)
-
-
North Rhine-Westphalia
-
Essen, North Rhine-Westphalia, Duitsland, 45359
- Unterfrintroper Hausarztzentrum Klinische Forschung ( Site 1542)
-
-
Saxony
-
Dresden, Saxony, Duitsland, 01307
- Universitaetsklinikum Carl Gustav Carus Dresden-Universitätsstudienzentrum für Stoffwechselerkranku ( Site 1508)
-
-
Saxony-Anhalt
-
Hohenmölsen, Saxony-Anhalt, Duitsland, 06679
- Hausarzt- und Diabetologische Schwerpunktpraxis Hohenmölsen - Weiβenfels ( Site 1527)
-
-
Thuringia
-
Bad Berka, Thuringia, Duitsland, 99437
- Zentralklinik Bad Berka ( Site 1530)
-
-
-
-
-
Hadera, Israël, 3810101
- Hillel Yaffe Medical Center ( Site 1705)
-
Haifa, Israël, 3109601
- Rambam Health Care Campus-internal department ( Site 1718)
-
Jerusalem, Israël, 9103102
- Shaare Zedek Medical Center ( Site 1710)
-
Jerusalem, Israël, 9112001
- Hadassah Medical Center ( Site 1709)
-
Jerusalem, Israël, 9112001
- Hadassah Medical Center ( Site 1706)
-
Kfar Saba, Israël, 4428164
- Meir Medical Center. ( Site 1714)
-
Petah Tikva, Israël, 4941 492
- Rabin Medical Center ( Site 1720)
-
Ramat Gan, Israël, 5265601
- Sheba Medical Center ( Site 1708)
-
Tsrifin, Israël, 7033001
- Yitzhak Shamir Medical Center. ( Site 1712)
-
-
-
-
-
Catania, Italië, 95122
- Azienda Ospedaliera Garibaldi ( Site 1810)
-
-
Lazio
-
Rome, Lazio, Italië, 00133
- Fondazione Policlinico Tor Vergata ( Site 1809)
-
-
Milano
-
Milan, Milano, Italië, 20138
- Centro Cardiologico Monzino ( Site 1804)
-
Milan, Milano, Italië, 20162
- ASST Grande Ospedale Metropolitano Niguarda-Unità Ricerche Cliniche della Cardiologia 4 ( Site 1811)
-
-
Piedmont
-
Turin, Piedmont, Italië, 10126
- Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino ( Site 1801)
-
-
Roma
-
Rome, Roma, Italië, 00189
- Azienda Ospedaliera Sant'Andrea-Department of Clinical and Molecular Medicine ( Site 1807)
-
-
-
-
-
Fukuoka, Japan, 810-0001
- Medical Corporation Hakuaikai Wellness Tenjin Clinic ( Site 3520)
-
Hiroshima, Japan, 730-8518
- Hiroshima City Hiroshima Citizens Hospital ( Site 3518)
-
Tokyo, Japan, 153-0051
- Mishuku Hospital ( Site 3524)
-
-
Fukuoka
-
Kitakyusyu-shi, Fukuoka, Japan, 807-0857
- Hirohata Naika Clinic ( Site 3513)
-
-
Ibaraki
-
Naka, Ibaraki, Japan, 311-0113
- Nakakinen clinic ( Site 3510)
-
Ushiku, Ibaraki, Japan, 300-1207
- Noritake Clinic ( Site 3512)
-
-
Ishikawa-ken
-
Kanazawa, Ishikawa-ken, Japan, 920-8650
- National Hospital Organization Kanazawa Medical Center ( Site 3508)
-
-
Iwate
-
Morioka, Iwate, Japan, 020-0132
- Hirano Medical Clinic ( Site 3522)
-
-
Miyagi
-
Sendai, Miyagi, Japan, 981-3133
- Shirai Healthcare Clinic Izumichuou ( Site 3527)
-
-
Osaka
-
Izumisano, Osaka, Japan, 598-8577
- Rinku General Medical Center ( Site 3503)
-
Kashihara, Osaka, Japan, 582-0005
- Shiraiwa Medical Clinic ( Site 3514)
-
Suita-shi, Osaka, Japan, 565-0853
- Medical Corporation Heishinkai OCROM Clinic ( Site 3501)
-
-
Saitama
-
Iruma, Saitama, Japan, 350-0495
- Saitama Medical University Hospital ( Site 3506)
-
-
Tokyo
-
Bunkyo-ku, Tokyo, Japan, 113-0033
- Teramoto Medical and Dental Clinic ( Site 3507)
-
Chuo-ku, Tokyo, Japan, 103-0027
- Tokyo-Eki Center-building Clinic ( Site 3505)
-
Chuo-ku, Tokyo, Japan, 104-0031
- Fukuwa Clinic ( Site 3504)
-
Katsushika-ku, Tokyo, Japan, 125-0054
- Kato Clinic of Internal Medicine ( Site 3509)
-
Mitaka, Tokyo, Japan, 181-0013
- Kanno Naika ( Site 3511)
-
Nerima-ku, Tokyo, Japan, 177-0041
- Sugawara Clinic ( Site 3519)
-
Shinjuku-ku, Tokyo, Japan, 160-0008
- Medical Corporation Heishinkai ToCROM Clinic ( Site 3502)
-
Shinjuku-ku, Tokyo, Japan, 160-0023
- Mitsukoshi Health and Welfare Foundation ( Site 3521)
-
tabashi City, Tokyo, Japan, 173-8606
- Teikyo University Hospital ( Site 3500)
-
Ōta-ku, Tokyo, Japan, 144-0051
- Shin Clinic ( Site 3517)
-
-
-
-
Jalisco
-
Guadalajara, Jalisco, Mexico, 44600
- Instituto Jalisciense de Investigacion en Diabetes y Obesidad-Endocrinology ( Site 1057)
-
-
Mexico City
-
Mexico City, Mexico City, Mexico, 14080
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 1071)
-
-
-
-
-
Madrid, Spanje, 28041
- Hospital Universitario 12 de Octubre-Internal Medicine. Unidad de Ensayos Clínicos ( Site 2319)
-
-
Andalusia
-
Seville, Andalusia, Spanje, 41009
- Hospital Universitario Virgen Macarena ( Site 2352)
-
-
Catalonia
-
Centelles, Catalonia, Spanje, 08500
- EBA CENTELLES ( Site 2311)
-
-
La Coruna
-
A Coruña, La Coruna, Spanje, 15001
- Hospital Abente y Lago ( Site 2356)
-
Santiago de Compostela, La Coruna, Spanje, 15706
- CHUS - Hospital Clinico Universitario-Cardiology - Clinical Research Unit ( Site 2320)
-
-
Madrid
-
Pozuelo de Alarcón, Madrid, Spanje, 28223
- HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-Endocrinologia y Nutrición ( Site 2344)
-
-
Madrid, Comunidad de
-
Alcorcón, Madrid, Comunidad de, Spanje, 28922
- Hospital Universitario Fundacion ALcorcon-Endocrinologia y Nutrición ( Site 2316)
-
-
Sevilla
-
Castilleja de la Cuesta, Sevilla, Spanje, 41950
- Vithas Hospital Sevilla-Unidad de Salud Metabólica. Diabetes y Obesidad ( Site 2349)
-
-
Valenciana, Comunitat
-
Valencia, Valenciana, Comunitat, Spanje, 46010
- HOSPITAL CLINICO DE VALENCIA-CARDIOLOGY ( Site 2321)
-
-
-
-
-
Changhua, Taiwan, 50006
- Changhua Christian Hospital ( Site 3101)
-
Kaohsiung City, Taiwan, 83301
- Chang Gung Memorial Hospital at Kaohsiung ( Site 3102)
-
Tainan, Taiwan, 704
- National Cheng Kung University Hospital ( Site 3107)
-
Taipei, Taiwan, 10002
- National Taiwan University Hospital ( Site 3100)
-
Taipei, Taiwan, 110
- Taipei Medical University Hospital-Cardiology ( Site 3108)
-
Taipei, Taiwan, 112
- Taipei Veterans General Hospital ( Site 3106)
-
-
Tainan
-
Tainan, Tainan, Taiwan, 71004
- Chi Mei Medical Center-Cardiology ( Site 3104)
-
-
-
-
-
Ankara, Turkije (Türkiye), 06800
- Ankara Bilkent Şehir Hastanesi-cardiology ( Site 2501)
-
Eskişehir, Turkije (Türkiye), 26480
- Eskisehir Osmangazi University-Cardiology ( Site 2510)
-
Kayseri, Turkije (Türkiye), 380280
- Erciyes Universitesi Tıp Fakultesi Hastaneleri-endocrine ( Site 2522)
-
Kocaeli, Turkije (Türkiye), 41380
- Kocaeli Üniversitesi-Cardiology ( Site 2516)
-
-
Ankara
-
Altindağ, Ankara, Turkije (Türkiye), 06230
- Hacettepe Universite Hastaneleri ( Site 2500)
-
-
İzmir
-
Bornova, İzmir, Turkije (Türkiye), 35100
- Ege Universitesi Hastanesi-Cardilogy Department ( Site 2502)
-
-
-
-
Alabama
-
Daphne, Alabama, Verenigde Staten, 36526
- Alliance for Multispecialty Research, LLC ( Site 0093)
-
Foley, Alabama, Verenigde Staten, 36535
- G&L Research ( Site 0043)
-
-
Arizona
-
Phoenix, Arizona, Verenigde Staten, 85020
- Synexus Clinical Research US, Inc.-Synexus Clinical Research US, Inc - Central Phoenix ( Site 0084)
-
-
California
-
Beverly Hills, California, Verenigde Staten, 90211
- National Heart Institute-Research ( Site 0087)
-
Sacramento, California, Verenigde Staten, 95821
- Clinical Trials Research ( Site 0115)
-
San Bernardino, California, Verenigde Staten, 92408
- Velocity Clinical Research, Banning ( Site 0017)
-
-
District of Columbia
-
Washington D.C., District of Columbia, Verenigde Staten, 20009
- Emerson Clinical Research Institute ( Site 0118)
-
-
Florida
-
Boca Raton, Florida, Verenigde Staten, 33434
- Excel Medical Clinical Trials ( Site 0053)
-
Coral Gables, Florida, Verenigde Staten, 33134
- Alliance for Multispecialty Research, LLC ( Site 0088)
-
Fort Myers, Florida, Verenigde Staten, 33912
- Alliance for Multispecialty Research, LLC ( Site 0094)
-
Hallandale, Florida, Verenigde Staten, 33009
- Velocity Clinical Research, Hallandale Beach ( Site 0018)
-
Jacksonville, Florida, Verenigde Staten, 32216
- Jacksonville Center for Clinical Research ( Site 0049)
-
Miramar, Florida, Verenigde Staten, 33027
- South Broward Research ( Site 0051)
-
Tampa, Florida, Verenigde Staten, 33607
- Clinical Research Trials of Florida ( Site 0063)
-
-
Georgia
-
Macon, Georgia, Verenigde Staten, 31210
- East Coast Institute for Research, LLC ( Site 0033)
-
-
Illinois
-
Flossmoor, Illinois, Verenigde Staten, 60422
- Healthcare Research Network - Chicago ( Site 0052)
-
-
Indiana
-
Evansville, Indiana, Verenigde Staten, 47714
- Synexus Clinical Research US, Inc. ( Site 0109)
-
Indianapolis, Indiana, Verenigde Staten, 46260
- Midwest Institute For Clinical Research ( Site 0059)
-
-
Kentucky
-
Lexington, Kentucky, Verenigde Staten, 40509
- Alliance for Multispecialty Research, LLC ( Site 0028)
-
Louisville, Kentucky, Verenigde Staten, 40213
- L-MARC Research Center ( Site 0001)
-
-
Louisiana
-
Covington, Louisiana, Verenigde Staten, 70433
- Velocity Clinical Research, Covington ( Site 0068)
-
-
Maryland
-
Rockville, Maryland, Verenigde Staten, 20854
- Velocity Clinical Research Rockville ( Site 0082)
-
-
Mississippi
-
Gulfport, Mississippi, Verenigde Staten, 39503
- Velocity Clinical Research, Gulfport ( Site 0039)
-
-
Missouri
-
Hazelwood, Missouri, Verenigde Staten, 63042
- Healthcare Research Network - St. Louis ( Site 0054)
-
-
Nevada
-
Las Vegas, Nevada, Verenigde Staten, 89106
- Jubilee Clinical Research ( Site 0106)
-
Las Vegas, Nevada, Verenigde Staten, 89119
- AB Clinical Trials ( Site 0070)
-
-
New Mexico
-
Albuquerque, New Mexico, Verenigde Staten, 87106
- New Mexico Clinical Research & Osteoporosis Center ( Site 0005)
-
-
New York
-
East Syracuse, New York, Verenigde Staten, 13057
- Velocity Clinical Research, Syracuse ( Site 0021)
-
New York, New York, Verenigde Staten, 10029
- Icahn School of Medicine at Mount Sinai-Cardiology ( Site 0002)
-
-
North Dakota
-
Fargo, North Dakota, Verenigde Staten, 58104
- Lillestol Research ( Site 0026)
-
-
Pennsylvania
-
Duncansville, Pennsylvania, Verenigde Staten, 16635
- altoona center for clinical research ( Site 0089)
-
Yardley, Pennsylvania, Verenigde Staten, 19067
- Cardiology Consultants of Philadelphia Yardley ( Site 0097)
-
-
South Carolina
-
Fort Mill, South Carolina, Verenigde Staten, 29707
- Piedmont Research Partners ( Site 0090)
-
Greenville, South Carolina, Verenigde Staten, 29615
- Velocity Clinical Research, Greenville ( Site 0023)
-
North Charleston, South Carolina, Verenigde Staten, 29405
- Coastal Carolina Research Center ( Site 0006)
-
-
South Dakota
-
Rapid City, South Dakota, Verenigde Staten, 57701
- Monument Health Clinical Research, a department of Monument -Monument Health Clinical Research, a d ( Site 0009)
-
-
Tennessee
-
Kingsport, Tennessee, Verenigde Staten, 37660
- Holston Medical Group ( Site 0048)
-
Knoxville, Tennessee, Verenigde Staten, 37920
- Alliance for Multispecialty Research, LLC ( Site 0008)
-
-
Texas
-
Dallas, Texas, Verenigde Staten, 75230
- Velocity Clinical Research, Dallas ( Site 0114)
-
Houston, Texas, Verenigde Staten, 77030
- Center for Cardiometabolic Disease Prevention/Baylor College of Medicine ( Site 0111)
-
San Antonio, Texas, Verenigde Staten, 78229
- Clinical Trials of Texas, LLC ( Site 0103)
-
-
Utah
-
Salt Lake City, Utah, Verenigde Staten, 84106
- Synexus Clinical Research US, Inc. ( Site 0110)
-
West Jordan, Utah, Verenigde Staten, 84088
- Velocity Clinical Research, Salt Lake City ( Site 0019)
-
-
Virginia
-
Manassas, Virginia, Verenigde Staten, 20110
- Manassas Clinical Research Center ( Site 0007)
-
Newport News, Virginia, Verenigde Staten, 23606
- Health Research of Hampton Roads, Inc. ( Site 0044)
-
Norfolk, Virginia, Verenigde Staten, 23502
- Alliance for Multispecialty Research, LLC ( Site 0101)
-
Richmond, Virginia, Verenigde Staten, 23294
- National Clinical Research, Inc ( Site 0061)
-
Suffolk, Virginia, Verenigde Staten, 23435
- Centricity Research Suffolk Family Medicine ( Site 0092)
-
-
Washington
-
Renton, Washington, Verenigde Staten, 98057
- Rainier Clinical Research Center ( Site 0116)
-
-
-
-
-
Seoul, Zuid -Korea, 03080
- Seoul National University Hospital ( Site 3001)
-
Seoul, Zuid -Korea, 03181
- Kangbuk Samsung Hospital ( Site 3009)
-
Seoul, Zuid -Korea, 03722
- Severance Hospital, Yonsei University Health System ( Site 3002)
-
Seoul, Zuid -Korea, 05505
- Asan Medical Center ( Site 3004)
-
Seoul, Zuid -Korea, 06351
- Samsung Medical Center-cardiology ( Site 3000)
-
Seoul, Zuid -Korea, 06591
- The Catholic Univ. of Korea Seoul St. Mary's Hospital-cardiology ( Site 3007)
-
-
Kang-won-do
-
Wŏnju, Kang-won-do, Zuid -Korea, 26426
- Wonju Severance Christian Hospital ( Site 3008)
-
-
Kwangju-Kwangyokshi
-
Gwangju, Kwangju-Kwangyokshi, Zuid -Korea, 61469
- Chonnam National University Hospital ( Site 3014)
-
-
Kyonggi-do
-
Seongnam, Kyonggi-do, Zuid -Korea, 13620
- Seoul National University Bundang Hospital ( Site 3005)
-
Suwon, Kyonggi-do, Zuid -Korea, 16499
- Ajou University Hospital ( Site 3006)
-
-
North Chungcheong
-
Cheongju-si, North Chungcheong, Zuid -Korea, 28644
- Chungbuk National University Hospital ( Site 3011)
-
-
Pusan-Kwangyokshi
-
Busan, Pusan-Kwangyokshi, Zuid -Korea, 49201
- Dong-A University Hospital ( Site 3013)
-
Busan, Pusan-Kwangyokshi, Zuid -Korea, 49241
- Pusan National University Hospital-Internal Medicine ( Site 3012)
-
Haeundae-gu, Pusan-Kwangyokshi, Zuid -Korea, 48108
- Inje University Haeundae Paik Hospital ( Site 3010)
-
-
Taegu-Kwangyokshi
-
Daegu, Taegu-Kwangyokshi, Zuid -Korea, 42601
- Keimyung University Dongsan Hospital CRC room 1 ( Site 3003)
-
-
-
-
Free State
-
Bloemfontein, Free State, Zuid-Afrika, 9301
- IATROS INTERNATIONAL ( Site 2247)
-
-
Gauteng
-
Johannesburg, Gauteng, Zuid-Afrika, 1818
- Soweto Clinical Trials Centre ( Site 2242)
-
Johannesburg, Gauteng, Zuid-Afrika, 2193
- Charlotte Maxeke Johannesburg Academic Hospital-WCR-LIPIDS ( Site 2241)
-
-
Western Cape
-
Bellville, Cape Town, Western Cape, Zuid-Afrika, 7530
- Tiervlei Trial Centre-Clinical ( Site 2246)
-
Cape Town, Western Cape, Zuid-Afrika, 7500
- TREAD Research ( Site 2253)
-
Cape Town, Western Cape, Zuid-Afrika, 7925
- University of Cape Town (UCT)-Medicine, Division of Lipidology ( Site 2259)
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Enlicitide Decanoate
Participants will receive 20 mg of enlicitide decanoate orally once daily (QD) for up to 52 weeks. |
Oral tablet
Andere namen:
|
|
Placebo-vergelijker: Placebo
Participants will receive enlicitide decanoate-matching placebo orally QD for up to 52 weeks. |
Oral tablet |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Mean Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24
Tijdsspanne: Baseline and Week 24
|
Blood samples collected at baseline and Week 24 were used to assess mean percent change in LDL-C. |
Baseline and Week 24
|
|
Number of Participants With One or More Adverse Events (AEs)
Tijdsspanne: Up to 60 weeks
|
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
|
|
Number of Participants Who Discontinued Study Drug Due to an AE
Tijdsspanne: Up to 52 weeks
|
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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Mean Percent Change From Baseline in LDL-C at Week 52
Tijdsspanne: Baseline and Week 52
|
Blood samples collected at baseline and Week 52 were used to assess mean percent change in LDL-C. |
Baseline and Week 52
|
|
Mean Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Week 24
Tijdsspanne: Baseline and Week 24
|
Blood samples collected at baseline and Week 24 were used to assess mean percent change in non-HDL-C. |
Baseline and Week 24
|
|
Mean Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24
Tijdsspanne: Baseline and Week 24
|
Blood samples collected at baseline and Week 24 were used to assess mean percent change in ApoB. |
Baseline and Week 24
|
|
Percent Change From Baseline in Lipoprotein(a) (Lp(a)) at Week 24
Tijdsspanne: Baseline and Week 24
|
Blood samples collected at baseline and Week 24 were used to assess percent change in Lp(a). |
Baseline and Week 24
|
|
Percentage of Participants With LDL-C <70 mg/dL and ≥50% Reduction From Baseline at Week 24
Tijdsspanne: Baseline and Week 24
|
Blood samples collected at baseline and Week 24 were used to assess the percentage of participants who have LDL-C <70 mg/dL and ≥50% reduction from baseline. Participants who did not have a Week 24 assessment are considered as not being at the LDL-C goal. |
Baseline and Week 24
|
|
Percentage of Participants With LDL-C <55 mg/dL and ≥50% Reduction From Baseline at Week 24
Tijdsspanne: Baseline and Week 24
|
Blood samples collected at baseline and Week 24 were used to assess the percentage of participants who have LDL-C <55 mg/dL and ≥50% reduction from baseline. Participants who did not have a Week 24 assessment are considered as not being at the LDL-C goal. |
Baseline and Week 24
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: Medical Director, Merck Sharp & Dohme LLC
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Nuttige links
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
10 augustus 2023
Primaire voltooiing (Werkelijk)
28 juli 2025
Studie voltooiing (Werkelijk)
28 juli 2025
Studieregistratiedata
Eerst ingediend
10 juli 2023
Eerst ingediend dat voldeed aan de QC-criteria
10 juli 2023
Eerst geplaatst (Werkelijk)
19 juli 2023
Updates van studierecords
Laatste update geplaatst (Werkelijk)
24 september 2026
Laatste update ingediend die voldeed aan QC-criteria
28 augustus 2026
Laatst geverifieerd
1 augustus 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Metabolisme, aangeboren fouten
- Genetische ziekten, aangeboren
- Metabole ziekten
- Hyperlipidemie
- Dyslipidemie
- Stoornissen in het metabolisme van lipiden
- Lipidenmetabolisme, aangeboren fouten
- Hyperlipoproteïnemieën
- Aangeboren, erfelijke en neonatale ziekten en afwijkingen
- Voedings- en stofwisselingsziekten
- Hypercholesterolemie
- Hyperlipoproteïnemie Type II
- MK-0616
Andere studie-ID-nummers
- 0616-013
- MK-0616-013 (Andere identificatie: MSD)
- U1111-1285-4164 (Register-ID: UTN)
- jRCT2031230320 (Register-ID: Japan Registry of Clinical Trials (jRCT))
- 2022-502777-42-01 (Register-ID: EU CT)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .