En studie av MK-0616 (oral PCSK9-hemmer) hos voksne med hyperkolesterolemi (MK-0616-013)
15. juli 2026 oppdatert av: Merck Sharp & Dohme LLC
En fase 3, randomisert, dobbeltblind, placebokontrollert studie for å evaluere effektiviteten og sikkerheten til MK-0616 hos voksne med hyperkolesterolemi
Målet med denne studien er å evaluere effekten, sikkerheten og toleransen til MK-0616 hos voksne deltakere med hyperkolesterolemi.
Den primære hypotesen er at MK-0616 er overlegen placebo på gjennomsnittlig prosentvis endring fra baseline i lavdensitetslipoproteinkolesterol (LDL-C) ved uke 24.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
2912
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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CABA, Argentina, C1056ABI
- Centro de Investigaciones Metabólicas (CINME)-Cardiology ( Site 0620)
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Buenos Aires
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CABA, Buenos Aires, Argentina, C1060ABN
- CEDIC ( Site 0612)
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Mar del Plata, Buenos Aires, Argentina, B7600FZO
- Instituto de Investigaciones Clínicas Mar del Plata ( Site 0605)
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Zárate, Buenos Aires, Argentina, B2800DGH
- Instituto de Investigaciones Clinicas Zarate ( Site 0600)
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Buenos Aires F.D.
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Buenos Aires, Buenos Aires F.D., Argentina, C1425AGC
- Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0604)
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Buenos Aires, Buenos Aires F.D., Argentina, C1426ABP
- Fundación Respirar ( Site 0610)
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Antioquia
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Medellín, Antioquia, Colombia, 050021
- Fundación Centro de Investigación Clínica CIC ( Site 0906)
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Atlántico
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Barranquilla, Atlántico, Colombia, 08001
- Ciensalud Ips S A S ( Site 0903)
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Barranquilla, Atlántico, Colombia, 080020
- Clinica de la Costa S.A.S. ( Site 0902)
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Cundinamarca
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Bogotá, Cundinamarca, Colombia, 110231
- Salud SURA Calle 100 ( Site 0918)
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Zipaquirá, Cundinamarca, Colombia, 250252
- Healthy Medical Center S.A.S ( Site 0913)
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Valle del Cauca Department
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Cali, Valle del Cauca Department, Colombia, 760032
- Fundación Valle del Lili ( Site 0904)
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Alabama
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Daphne, Alabama, Forente stater, 36526
- Alliance for Multispecialty Research, LLC ( Site 0093)
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Foley, Alabama, Forente stater, 36535
- G&L Research ( Site 0043)
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Arizona
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Phoenix, Arizona, Forente stater, 85020
- Synexus Clinical Research US, Inc.-Synexus Clinical Research US, Inc - Central Phoenix ( Site 0084)
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California
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Beverly Hills, California, Forente stater, 90211
- National Heart Institute-Research ( Site 0087)
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Sacramento, California, Forente stater, 95821
- Clinical Trials Research ( Site 0115)
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San Bernardino, California, Forente stater, 92408
- Velocity Clinical Research, Banning ( Site 0017)
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District of Columbia
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Washington D.C., District of Columbia, Forente stater, 20009
- Emerson Clinical Research Institute ( Site 0118)
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Florida
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Boca Raton, Florida, Forente stater, 33434
- Excel Medical Clinical Trials ( Site 0053)
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Coral Gables, Florida, Forente stater, 33134
- Alliance for Multispecialty Research, LLC ( Site 0088)
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Fort Myers, Florida, Forente stater, 33912
- Alliance for Multispecialty Research, LLC ( Site 0094)
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Hallandale, Florida, Forente stater, 33009
- Velocity Clinical Research, Hallandale Beach ( Site 0018)
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Jacksonville, Florida, Forente stater, 32216
- Jacksonville Center for Clinical Research ( Site 0049)
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Miramar, Florida, Forente stater, 33027
- South Broward Research ( Site 0051)
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Tampa, Florida, Forente stater, 33607
- Clinical Research Trials of Florida ( Site 0063)
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Georgia
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Macon, Georgia, Forente stater, 31210
- East Coast Institute for Research, LLC ( Site 0033)
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Illinois
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Flossmoor, Illinois, Forente stater, 60422
- Healthcare Research Network - Chicago ( Site 0052)
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Indiana
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Evansville, Indiana, Forente stater, 47714
- Synexus Clinical Research US, Inc. ( Site 0109)
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Indianapolis, Indiana, Forente stater, 46260
- Midwest Institute For Clinical Research ( Site 0059)
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Kentucky
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Lexington, Kentucky, Forente stater, 40509
- Alliance for Multispecialty Research, LLC ( Site 0028)
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Louisville, Kentucky, Forente stater, 40213
- L-MARC Research Center ( Site 0001)
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Louisiana
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Covington, Louisiana, Forente stater, 70433
- Velocity Clinical Research, Covington ( Site 0068)
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Maryland
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Rockville, Maryland, Forente stater, 20854
- Velocity Clinical Research Rockville ( Site 0082)
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Mississippi
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Gulfport, Mississippi, Forente stater, 39503
- Velocity Clinical Research, Gulfport ( Site 0039)
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Missouri
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Hazelwood, Missouri, Forente stater, 63042
- Healthcare Research Network - St. Louis ( Site 0054)
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Nevada
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Las Vegas, Nevada, Forente stater, 89106
- Jubilee Clinical Research ( Site 0106)
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Las Vegas, Nevada, Forente stater, 89119
- AB Clinical Trials ( Site 0070)
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New Mexico
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Albuquerque, New Mexico, Forente stater, 87106
- New Mexico Clinical Research & Osteoporosis Center ( Site 0005)
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New York
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East Syracuse, New York, Forente stater, 13057
- Velocity Clinical Research, Syracuse ( Site 0021)
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New York, New York, Forente stater, 10029
- Icahn School of Medicine at Mount Sinai-Cardiology ( Site 0002)
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North Dakota
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Fargo, North Dakota, Forente stater, 58104
- Lillestol Research ( Site 0026)
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Pennsylvania
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Duncansville, Pennsylvania, Forente stater, 16635
- altoona center for clinical research ( Site 0089)
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Yardley, Pennsylvania, Forente stater, 19067
- Cardiology Consultants of Philadelphia Yardley ( Site 0097)
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South Carolina
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Fort Mill, South Carolina, Forente stater, 29707
- Piedmont Research Partners ( Site 0090)
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Greenville, South Carolina, Forente stater, 29615
- Velocity Clinical Research, Greenville ( Site 0023)
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North Charleston, South Carolina, Forente stater, 29405
- Coastal Carolina Research Center ( Site 0006)
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South Dakota
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Rapid City, South Dakota, Forente stater, 57701
- Monument Health Clinical Research, a department of Monument -Monument Health Clinical Research, a d ( Site 0009)
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Tennessee
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Kingsport, Tennessee, Forente stater, 37660
- Holston Medical Group ( Site 0048)
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Knoxville, Tennessee, Forente stater, 37920
- Alliance for Multispecialty Research, LLC ( Site 0008)
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Texas
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Dallas, Texas, Forente stater, 75230
- Velocity Clinical Research, Dallas ( Site 0114)
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Houston, Texas, Forente stater, 77030
- Center for Cardiometabolic Disease Prevention/Baylor College of Medicine ( Site 0111)
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San Antonio, Texas, Forente stater, 78229
- Clinical Trials of Texas, LLC ( Site 0103)
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Utah
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Salt Lake City, Utah, Forente stater, 84106
- Synexus Clinical Research US, Inc. ( Site 0110)
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West Jordan, Utah, Forente stater, 84088
- Velocity Clinical Research, Salt Lake City ( Site 0019)
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Virginia
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Manassas, Virginia, Forente stater, 20110
- Manassas Clinical Research Center ( Site 0007)
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Newport News, Virginia, Forente stater, 23606
- Health Research of Hampton Roads, Inc. ( Site 0044)
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Norfolk, Virginia, Forente stater, 23502
- Alliance for Multispecialty Research, LLC ( Site 0101)
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Richmond, Virginia, Forente stater, 23294
- National Clinical Research, Inc ( Site 0061)
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Suffolk, Virginia, Forente stater, 23435
- Centricity Research Suffolk Family Medicine ( Site 0092)
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Washington
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Renton, Washington, Forente stater, 98057
- Rainier Clinical Research Center ( Site 0116)
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Hadera, Israel, 3810101
- Hillel Yaffe Medical Center ( Site 1705)
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Haifa, Israel, 3109601
- Rambam Health Care Campus-internal department ( Site 1718)
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Jerusalem, Israel, 9103102
- Shaare Zedek Medical Center ( Site 1710)
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Jerusalem, Israel, 9112001
- Hadassah Medical Center ( Site 1709)
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Jerusalem, Israel, 9112001
- Hadassah Medical Center ( Site 1706)
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Kfar Saba, Israel, 4428164
- Meir Medical Center. ( Site 1714)
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Petah Tikva, Israel, 4941 492
- Rabin Medical Center ( Site 1720)
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Ramat Gan, Israel, 5265601
- Sheba Medical Center ( Site 1708)
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Ẕerifin, Israel, 7033001
- Yitzhak Shamir Medical Center. ( Site 1712)
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Catania, Italia, 95122
- Azienda Ospedaliera Garibaldi ( Site 1810)
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Lazio
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Rome, Lazio, Italia, 00133
- Fondazione Policlinico Tor Vergata ( Site 1809)
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Milano
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Milan, Milano, Italia, 20138
- Centro Cardiologico Monzino ( Site 1804)
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Milan, Milano, Italia, 20162
- ASST Grande Ospedale Metropolitano Niguarda-Unità Ricerche Cliniche della Cardiologia 4 ( Site 1811)
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Piedmont
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Turin, Piedmont, Italia, 10126
- Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino ( Site 1801)
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Roma
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Rome, Roma, Italia, 00189
- Azienda Ospedaliera Sant'Andrea-Department of Clinical and Molecular Medicine ( Site 1807)
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Fukuoka, Japan, 810-0001
- Medical Corporation Hakuaikai Wellness Tenjin Clinic ( Site 3520)
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Hiroshima, Japan, 730-8518
- Hiroshima City Hiroshima Citizens Hospital ( Site 3518)
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Tokyo, Japan, 153-0051
- Mishuku Hospital ( Site 3524)
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Fukuoka
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Kitakyusyu-shi, Fukuoka, Japan, 807-0857
- Hirohata Naika Clinic ( Site 3513)
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Ibaraki
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Naka, Ibaraki, Japan, 311-0113
- Nakakinen clinic ( Site 3510)
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Ushiku, Ibaraki, Japan, 300-1207
- Noritake Clinic ( Site 3512)
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Ishikawa-ken
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Kanazawa, Ishikawa-ken, Japan, 920-8650
- National Hospital Organization Kanazawa Medical Center ( Site 3508)
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Iwate
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Morioka, Iwate, Japan, 020-0132
- Hirano Medical Clinic ( Site 3522)
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Miyagi
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Sendai, Miyagi, Japan, 981-3133
- Shirai Healthcare Clinic Izumichuou ( Site 3527)
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Osaka
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Izumisano, Osaka, Japan, 598-8577
- Rinku General Medical Center ( Site 3503)
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Kashihara, Osaka, Japan, 582-0005
- Shiraiwa Medical Clinic ( Site 3514)
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Suita-shi, Osaka, Japan, 565-0853
- Medical Corporation Heishinkai OCROM Clinic ( Site 3501)
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Saitama
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Iruma, Saitama, Japan, 350-0495
- Saitama Medical University Hospital ( Site 3506)
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Tokyo
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Bunkyo-ku, Tokyo, Japan, 113-0033
- Teramoto Medical and Dental Clinic ( Site 3507)
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Chuo-ku, Tokyo, Japan, 103-0027
- Tokyo-Eki Center-building Clinic ( Site 3505)
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Chuo-ku, Tokyo, Japan, 104-0031
- Fukuwa Clinic ( Site 3504)
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Itabashi-ku, Tokyo, Japan, 173-8606
- Teikyo University Hospital ( Site 3500)
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Katsushika-ku, Tokyo, Japan, 125-0054
- Kato Clinic of Internal Medicine ( Site 3509)
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Mitaka, Tokyo, Japan, 181-0013
- Kanno Naika ( Site 3511)
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Nerima-ku, Tokyo, Japan, 177-0041
- Sugawara Clinic ( Site 3519)
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Shinjuku-ku, Tokyo, Japan, 160-0023
- Mitsukoshi Health and Welfare Foundation ( Site 3521)
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Shinjuku-ku, Tokyo, Japan, 160-0008
- Medical Corporation Heishinkai ToCROM Clinic ( Site 3502)
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Ōta-ku, Tokyo, Japan, 144-0051
- Shin Clinic ( Site 3517)
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100029
- Beijing Anzhen Hospital, Capital Medical University-Cardiovascular ( Site 3300)
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Beijing, Beijing Municipality, Kina, 100050
- Beijing Friendship Hospital Affiliate of Capital University-Cardiology ( Site 3303)
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Kina, 400072
- The Second Affiliated Hospital of Chongqing Medical University ( Site 3320)
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Chongqing, Chongqing Municipality, Kina, 404000
- Chongqing University Three Gorges Hospital ( Site 3321)
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Guangdong
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Guangzhou, Guangdong, Kina, 510080
- Guangdong Provincial People's Hospital-Cardiology ( Site 3304)
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Guangzhou, Guangdong, Kina, 510280
- Zhujiang Hospital of Southern Medical University ( Site 3329)
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Huizhou, Guangdong, Kina, 516001
- Huizhou Municipal Central Hospital ( Site 3379)
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Shenzhen, Guangdong, Kina, 518053
- The University of Hong Kong-Shenzhen Hospital-Cardiovascular department ( Site 3318)
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Hubei
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Jingzhou, Hubei, Kina, 434036
- Jingzhou Central Hospital-Cardiology ( Site 3376)
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Wuhan, Hubei, Kina, 430030
- Wuhan Fourth Hospital ( Site 3356)
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Hunan
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Changsha, Hunan, Kina, 410005
- Hunan Provincial People's Hospital-Cardiology ( Site 3317)
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Jiangsu
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Changzhou, Jiangsu, Kina, 213000
- Changzhou Second People's Hospital-Cardiology ( Site 3373)
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Yangzhou, Jiangsu, Kina, 225001
- Northern Jiangsu People's Hospital ( Site 3308)
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Jiangxi
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Nanchang, Jiangxi, Kina, 330003
- The Third Hospital of Nanchang - Fuhe-cardiology ( Site 3378)
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Jilin
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Siping, Jilin, Kina, 136000
- Siping Central People's Hospital-Cardiovascular Department ( Site 3311)
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Shaanxi
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Xianyang, Shaanxi, Kina, 712000
- Xianyang Hospital of Yan'an University ( Site 3340)
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Sichuan
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Chengdu, Sichuan, Kina, 610021
- Chengdu Second Municipal People's Hospital ( Site 3332)
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Zhejiang
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Lishui, Zhejiang, Kina, 323000
- People's Hospital of Lishui City-department of cardiovascular ( Site 3302)
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Jalisco
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Guadalajara, Jalisco, Mexico, 44600
- Instituto Jalisciense de Investigacion en Diabetes y Obesidad-Endocrinology ( Site 1057)
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Mexico City
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Mexico City, Mexico City, Mexico, 14080
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 1071)
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Madrid, Spania, 28041
- Hospital Universitario 12 de Octubre-Internal Medicine. Unidad de Ensayos Clínicos ( Site 2319)
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Andalusia
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Seville, Andalusia, Spania, 41009
- Hospital Universitario Virgen Macarena ( Site 2352)
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Catalonia
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Centelles, Catalonia, Spania, 08500
- EBA CENTELLES ( Site 2311)
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La Coruna
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A Coruña, La Coruna, Spania, 15001
- Hospital Abente y Lago ( Site 2356)
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Santiago de Compostela, La Coruna, Spania, 15706
- CHUS - Hospital Clinico Universitario-Cardiology - Clinical Research Unit ( Site 2320)
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Madrid
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Pozuelo de Alarcón, Madrid, Spania, 28223
- HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-Endocrinologia y Nutrición ( Site 2344)
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Madrid, Comunidad de
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Alcorcón, Madrid, Comunidad de, Spania, 28922
- Hospital Universitario Fundacion ALcorcon-Endocrinologia y Nutrición ( Site 2316)
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Sevilla
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Castilleja de la Cuesta, Sevilla, Spania, 41950
- Vithas Hospital Sevilla-Unidad de Salud Metabólica. Diabetes y Obesidad ( Site 2349)
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Valenciana, Comunitat
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Valencia, Valenciana, Comunitat, Spania, 46010
- HOSPITAL CLINICO DE VALENCIA-CARDIOLOGY ( Site 2321)
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Seoul, Sør -Korea, 03080
- Seoul National University Hospital ( Site 3001)
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Seoul, Sør -Korea, 03181
- Kangbuk Samsung Hospital ( Site 3009)
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Seoul, Sør -Korea, 03722
- Severance Hospital, Yonsei University Health System ( Site 3002)
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Seoul, Sør -Korea, 05505
- Asan Medical Center ( Site 3004)
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Seoul, Sør -Korea, 06351
- Samsung Medical Center-cardiology ( Site 3000)
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Seoul, Sør -Korea, 06591
- The Catholic Univ. of Korea Seoul St. Mary's Hospital-cardiology ( Site 3007)
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Kang-won-do
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Wŏnju, Kang-won-do, Sør -Korea, 26426
- Wonju Severance Christian Hospital ( Site 3008)
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Kwangju-Kwangyokshi
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Gwangju, Kwangju-Kwangyokshi, Sør -Korea, 61469
- Chonnam National University Hospital ( Site 3014)
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Kyonggi-do
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Seongnam, Kyonggi-do, Sør -Korea, 13620
- Seoul National University Bundang Hospital ( Site 3005)
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Suwon, Kyonggi-do, Sør -Korea, 16499
- Ajou University Hospital ( Site 3006)
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North Chungcheong
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Cheongju-si, North Chungcheong, Sør -Korea, 28644
- Chungbuk National University Hospital ( Site 3011)
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Pusan-Kwangyokshi
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Busan, Pusan-Kwangyokshi, Sør -Korea, 49201
- Dong-A University Hospital ( Site 3013)
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Busan, Pusan-Kwangyokshi, Sør -Korea, 49241
- Pusan National University Hospital-Internal Medicine ( Site 3012)
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Haeundae-gu, Pusan-Kwangyokshi, Sør -Korea, 48108
- Inje University Haeundae Paik Hospital ( Site 3010)
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Taegu-Kwangyokshi
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Daegu, Taegu-Kwangyokshi, Sør -Korea, 42601
- Keimyung University Dongsan Hospital CRC room 1 ( Site 3003)
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Free State
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Bloemfontein, Free State, Sør-Afrika, 9301
- IATROS INTERNATIONAL ( Site 2247)
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Gauteng
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Johannesburg, Gauteng, Sør-Afrika, 1818
- Soweto Clinical Trials Centre ( Site 2242)
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Johannesburg, Gauteng, Sør-Afrika, 2193
- Charlotte Maxeke Johannesburg Academic Hospital-WCR-LIPIDS ( Site 2241)
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Western Cape
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Bellville, Cape Town, Western Cape, Sør-Afrika, 7530
- Tiervlei Trial Centre-Clinical ( Site 2246)
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Cape Town, Western Cape, Sør-Afrika, 7500
- TREAD Research ( Site 2253)
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Cape Town, Western Cape, Sør-Afrika, 7925
- University of Cape Town (UCT)-Medicine, Division of Lipidology ( Site 2259)
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Changhua, Taiwan, 50006
- Changhua Christian Hospital ( Site 3101)
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Kaohsiung City, Taiwan, 83301
- Chang Gung Memorial Hospital at Kaohsiung ( Site 3102)
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Tainan, Taiwan, 704
- National Cheng Kung University Hospital ( Site 3107)
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Taipei, Taiwan, 10002
- National Taiwan University Hospital ( Site 3100)
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Taipei, Taiwan, 110
- Taipei Medical University Hospital-Cardiology ( Site 3108)
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Taipei, Taiwan, 112
- Taipei Veterans General Hospital ( Site 3106)
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Tainan
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Tainan, Tainan, Taiwan, 71004
- Chi Mei Medical Center-Cardiology ( Site 3104)
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Ankara, Tyrkia (Türkiye), 06800
- Ankara Bilkent Şehir Hastanesi-cardiology ( Site 2501)
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Eskişehir, Tyrkia (Türkiye), 26480
- Eskisehir Osmangazi University-Cardiology ( Site 2510)
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Kayseri, Tyrkia (Türkiye), 380280
- Erciyes Universitesi Tıp Fakultesi Hastaneleri-endocrine ( Site 2522)
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Kocaeli, Tyrkia (Türkiye), 41380
- Kocaeli Üniversitesi-Cardiology ( Site 2516)
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Ankara
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Altindağ, Ankara, Tyrkia (Türkiye), 06230
- Hacettepe Universite Hastaneleri ( Site 2500)
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İzmir
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Bornova, İzmir, Tyrkia (Türkiye), 35100
- Ege Universitesi Hastanesi-Cardilogy Department ( Site 2502)
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Berlin, Tyskland, 10787
- Velocity Clinical Research GmbH Berlin ( Site 1502)
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Berlin, Tyskland, 12203
- Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 1533)
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North Rhine-Westphalia
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Essen, North Rhine-Westphalia, Tyskland, 45359
- Unterfrintroper Hausarztzentrum Klinische Forschung ( Site 1542)
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Saxony
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Dresden, Saxony, Tyskland, 01307
- Universitaetsklinikum Carl Gustav Carus Dresden-Universitätsstudienzentrum für Stoffwechselerkranku ( Site 1508)
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Saxony-Anhalt
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Hohenmölsen, Saxony-Anhalt, Tyskland, 06679
- Hausarzt- und Diabetologische Schwerpunktpraxis Hohenmölsen - Weiβenfels ( Site 1527)
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Thuringia
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Bad Berka, Thuringia, Tyskland, 99437
- Zentralklinik Bad Berka ( Site 1530)
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inklusjonskriterier:
- Har en historie med en alvorlig aterosklerotisk kardiovaskulær sykdom (ASCVD) og LDL-C ≥55 mg/dL ELLER, hvis ingen historie med en større ASCVD-hendelse, har middels til høy risiko for utvikling av en første større ASCVD-hendelse og LDL-C ≥70 mg/dL
- Behandles med moderat eller høy intensitet statin ELLER behandles med lav intensitet statin med dokumentasjon på intoleranse mot moderat eller høy intensitet statin ELLER får ikke statiner med dokumentasjon på statin intoleranse
- Hvis på noen lipidsenkende terapier (LLT), bør du ha en stabil dose uten planlagt medisinendring
Ekskluderingskriterier:
- Har en historie med homozygot familiær hyperkolesterolemi (FH) basert på genetiske eller kliniske kriterier, sammensatt heterozygot FH eller dobbel heterozygot FH
- Har en historie med hjertesvikt eller hjertesvikt sykehusinnleggelse innen 3 måneder før første studiebesøk
- Gjennomgår eller har tidligere gjennomgått et LDL-C afereseprogram innen 3 måneder før første studiebesøk eller planlegger å starte et LDL-C afereseprogram
- Ble tidligere behandlet/behandles med visse andre kolesterolsenkende medisiner, inkludert proteinkonvertase subtilisin/kexin type 9 (PCSK9) hemmere uten tilstrekkelig utvasking
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Enlicitide Decanoate
Deltakerne vil motta 20 mg enlicitide-dekanoat oralt en gang daglig (QD) i opptil 52 uker.
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Oral tablett
Andre navn:
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Placebo komparator: Placebo
Deltakerne vil motta enlicitide dekanoat-matchende placebo oral QD i opptil 52 uker.
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Oral tablett
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Mean Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24
Tidsramme: Baseline and Week 24
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Blood samples collected at baseline and Week 24 were used to assess mean percent change in LDL-C.
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Baseline and Week 24
|
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Number of Participants With One or More Adverse Events (AEs)
Tidsramme: 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.
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Up to 60 weeks
|
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Number of Participants Who Discontinued Study Drug Due to an AE
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Mean Percent Change From Baseline in LDL-C at Week 52
Tidsramme: Baseline and Week 52
|
Blood samples collected at baseline and Week 52 were used to assess mean percent change in LDL-C.
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Baseline and Week 52
|
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Mean Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Week 24
Tidsramme: 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
|
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Mean Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24
Tidsramme: 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
|
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Percent Change From Baseline in Lipoprotein(a) (Lp(a)) at Week 24
Tidsramme: Baseline and Week 24
|
Blood samples collected at baseline and Week 24 were used to assess percent change in Lp(a).
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Baseline and Week 24
|
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Percentage of Participants With LDL-C <70 mg/dL and ≥50% Reduction From Baseline at Week 24
Tidsramme: 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
|
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Percentage of Participants With LDL-C <55 mg/dL and ≥50% Reduction From Baseline at Week 24
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Medical Director, Merck Sharp & Dohme LLC
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
10. august 2023
Primær fullføring (Faktiske)
28. juli 2025
Studiet fullført (Faktiske)
28. juli 2025
Datoer for studieregistrering
Først innsendt
10. juli 2023
Først innsendt som oppfylte QC-kriteriene
10. juli 2023
Først lagt ut (Faktiske)
19. juli 2023
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
6. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Metabolisme, medfødte feil
- Genetiske sykdommer, medfødte
- Metabolske sykdommer
- Hyperlipidemier
- Dyslipidemier
- Lipidmetabolismeforstyrrelser
- Lipidmetabolisme, medfødte feil
- Hyperlipoproteinemier
- Medfødte, arvelige og neonatale sykdommer og abnormiteter
- Ernæringsmessige og metabolske sykdommer
- Hyperkolesterolemi
- Hyperlipoproteinemi type II
- Substandard medisiner
- Farmasøytiske preparater
- MK-0616
Andre studie-ID-numre
- 0616-013
- MK-0616-013 (Annen identifikator: MSD)
- U1111-1285-4164 (Registeridentifikator: UTN)
- jRCT2031230320 (Registeridentifikator: Japan Registry of Clinical Trials (jRCT))
- 2022-502777-42-00 (Registeridentifikator: EU CT)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .