En studie av MK-0616 (oral PCSK9-hämmare) hos vuxna med hyperkolesterolemi (MK-0616-013)
28 augusti 2026 uppdaterad av: Merck Sharp & Dohme LLC
En fas 3, randomiserad, dubbelblind, placebokontrollerad studie för att utvärdera effektiviteten och säkerheten av MK-0616 hos vuxna med hyperkolesterolemi
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
2912
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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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, Förenta staterna, 36526
- Alliance for Multispecialty Research, LLC ( Site 0093)
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Foley, Alabama, Förenta staterna, 36535
- G&L Research ( Site 0043)
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Arizona
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Phoenix, Arizona, Förenta staterna, 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, Förenta staterna, 90211
- National Heart Institute-Research ( Site 0087)
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Sacramento, California, Förenta staterna, 95821
- Clinical Trials Research ( Site 0115)
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San Bernardino, California, Förenta staterna, 92408
- Velocity Clinical Research, Banning ( Site 0017)
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District of Columbia
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Washington D.C., District of Columbia, Förenta staterna, 20009
- Emerson Clinical Research Institute ( Site 0118)
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Florida
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Boca Raton, Florida, Förenta staterna, 33434
- Excel Medical Clinical Trials ( Site 0053)
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Coral Gables, Florida, Förenta staterna, 33134
- Alliance for Multispecialty Research, LLC ( Site 0088)
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Fort Myers, Florida, Förenta staterna, 33912
- Alliance for Multispecialty Research, LLC ( Site 0094)
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Hallandale, Florida, Förenta staterna, 33009
- Velocity Clinical Research, Hallandale Beach ( Site 0018)
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Jacksonville, Florida, Förenta staterna, 32216
- Jacksonville Center for Clinical Research ( Site 0049)
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Miramar, Florida, Förenta staterna, 33027
- South Broward Research ( Site 0051)
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Tampa, Florida, Förenta staterna, 33607
- Clinical Research Trials of Florida ( Site 0063)
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Georgia
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Macon, Georgia, Förenta staterna, 31210
- East Coast Institute for Research, LLC ( Site 0033)
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Illinois
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Flossmoor, Illinois, Förenta staterna, 60422
- Healthcare Research Network - Chicago ( Site 0052)
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Indiana
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Evansville, Indiana, Förenta staterna, 47714
- Synexus Clinical Research US, Inc. ( Site 0109)
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Indianapolis, Indiana, Förenta staterna, 46260
- Midwest Institute For Clinical Research ( Site 0059)
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Kentucky
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Lexington, Kentucky, Förenta staterna, 40509
- Alliance for Multispecialty Research, LLC ( Site 0028)
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Louisville, Kentucky, Förenta staterna, 40213
- L-MARC Research Center ( Site 0001)
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Louisiana
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Covington, Louisiana, Förenta staterna, 70433
- Velocity Clinical Research, Covington ( Site 0068)
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Maryland
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Rockville, Maryland, Förenta staterna, 20854
- Velocity Clinical Research Rockville ( Site 0082)
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Mississippi
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Gulfport, Mississippi, Förenta staterna, 39503
- Velocity Clinical Research, Gulfport ( Site 0039)
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Missouri
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Hazelwood, Missouri, Förenta staterna, 63042
- Healthcare Research Network - St. Louis ( Site 0054)
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Nevada
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Las Vegas, Nevada, Förenta staterna, 89106
- Jubilee Clinical Research ( Site 0106)
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Las Vegas, Nevada, Förenta staterna, 89119
- AB Clinical Trials ( Site 0070)
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New Mexico
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Albuquerque, New Mexico, Förenta staterna, 87106
- New Mexico Clinical Research & Osteoporosis Center ( Site 0005)
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New York
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East Syracuse, New York, Förenta staterna, 13057
- Velocity Clinical Research, Syracuse ( Site 0021)
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New York, New York, Förenta staterna, 10029
- Icahn School of Medicine at Mount Sinai-Cardiology ( Site 0002)
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North Dakota
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Fargo, North Dakota, Förenta staterna, 58104
- Lillestol Research ( Site 0026)
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Pennsylvania
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Duncansville, Pennsylvania, Förenta staterna, 16635
- altoona center for clinical research ( Site 0089)
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Yardley, Pennsylvania, Förenta staterna, 19067
- Cardiology Consultants of Philadelphia Yardley ( Site 0097)
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South Carolina
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Fort Mill, South Carolina, Förenta staterna, 29707
- Piedmont Research Partners ( Site 0090)
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Greenville, South Carolina, Förenta staterna, 29615
- Velocity Clinical Research, Greenville ( Site 0023)
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North Charleston, South Carolina, Förenta staterna, 29405
- Coastal Carolina Research Center ( Site 0006)
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South Dakota
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Rapid City, South Dakota, Förenta staterna, 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, Förenta staterna, 37660
- Holston Medical Group ( Site 0048)
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Knoxville, Tennessee, Förenta staterna, 37920
- Alliance for Multispecialty Research, LLC ( Site 0008)
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Texas
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Dallas, Texas, Förenta staterna, 75230
- Velocity Clinical Research, Dallas ( Site 0114)
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Houston, Texas, Förenta staterna, 77030
- Center for Cardiometabolic Disease Prevention/Baylor College of Medicine ( Site 0111)
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San Antonio, Texas, Förenta staterna, 78229
- Clinical Trials of Texas, LLC ( Site 0103)
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Utah
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Salt Lake City, Utah, Förenta staterna, 84106
- Synexus Clinical Research US, Inc. ( Site 0110)
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West Jordan, Utah, Förenta staterna, 84088
- Velocity Clinical Research, Salt Lake City ( Site 0019)
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Virginia
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Manassas, Virginia, Förenta staterna, 20110
- Manassas Clinical Research Center ( Site 0007)
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Newport News, Virginia, Förenta staterna, 23606
- Health Research of Hampton Roads, Inc. ( Site 0044)
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Norfolk, Virginia, Förenta staterna, 23502
- Alliance for Multispecialty Research, LLC ( Site 0101)
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Richmond, Virginia, Förenta staterna, 23294
- National Clinical Research, Inc ( Site 0061)
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Suffolk, Virginia, Förenta staterna, 23435
- Centricity Research Suffolk Family Medicine ( Site 0092)
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Washington
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Renton, Washington, Förenta staterna, 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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Tsrifin, Israel, 7033001
- Yitzhak Shamir Medical Center. ( Site 1712)
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Catania, Italien, 95122
- Azienda Ospedaliera Garibaldi ( Site 1810)
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Lazio
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Rome, Lazio, Italien, 00133
- Fondazione Policlinico Tor Vergata ( Site 1809)
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Milano
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Milan, Milano, Italien, 20138
- Centro Cardiologico Monzino ( Site 1804)
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Milan, Milano, Italien, 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, Italien, 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, Italien, 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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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, 160-0008
- Medical Corporation Heishinkai ToCROM Clinic ( Site 3502)
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Shinjuku-ku, Tokyo, Japan, 160-0023
- Mitsukoshi Health and Welfare Foundation ( Site 3521)
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tabashi City, Tokyo, Japan, 173-8606
- Teikyo University Hospital ( Site 3500)
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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, Mexiko, 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, Mexiko, 14080
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 1071)
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Madrid, Spanien, 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, Spanien, 41009
- Hospital Universitario Virgen Macarena ( Site 2352)
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Catalonia
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Centelles, Catalonia, Spanien, 08500
- EBA CENTELLES ( Site 2311)
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La Coruna
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A Coruña, La Coruna, Spanien, 15001
- Hospital Abente y Lago ( Site 2356)
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Santiago de Compostela, La Coruna, Spanien, 15706
- CHUS - Hospital Clinico Universitario-Cardiology - Clinical Research Unit ( Site 2320)
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Madrid
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Pozuelo de Alarcón, Madrid, Spanien, 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, Spanien, 28922
- Hospital Universitario Fundacion ALcorcon-Endocrinologia y Nutrición ( Site 2316)
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Sevilla
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Castilleja de la Cuesta, Sevilla, Spanien, 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, Spanien, 46010
- HOSPITAL CLINICO DE VALENCIA-CARDIOLOGY ( Site 2321)
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Free State
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Bloemfontein, Free State, Sydafrika, 9301
- IATROS INTERNATIONAL ( Site 2247)
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Gauteng
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Johannesburg, Gauteng, Sydafrika, 1818
- Soweto Clinical Trials Centre ( Site 2242)
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Johannesburg, Gauteng, Sydafrika, 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, Sydafrika, 7530
- Tiervlei Trial Centre-Clinical ( Site 2246)
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Cape Town, Western Cape, Sydafrika, 7500
- TREAD Research ( Site 2253)
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Cape Town, Western Cape, Sydafrika, 7925
- University of Cape Town (UCT)-Medicine, Division of Lipidology ( Site 2259)
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Seoul, Sydkorea, 03080
- Seoul National University Hospital ( Site 3001)
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Seoul, Sydkorea, 03181
- Kangbuk Samsung Hospital ( Site 3009)
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Seoul, Sydkorea, 03722
- Severance Hospital, Yonsei University Health System ( Site 3002)
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Seoul, Sydkorea, 05505
- Asan Medical Center ( Site 3004)
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Seoul, Sydkorea, 06351
- Samsung Medical Center-cardiology ( Site 3000)
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Seoul, Sydkorea, 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, Sydkorea, 26426
- Wonju Severance Christian Hospital ( Site 3008)
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Kwangju-Kwangyokshi
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Gwangju, Kwangju-Kwangyokshi, Sydkorea, 61469
- Chonnam National University Hospital ( Site 3014)
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Kyonggi-do
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Seongnam, Kyonggi-do, Sydkorea, 13620
- Seoul National University Bundang Hospital ( Site 3005)
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Suwon, Kyonggi-do, Sydkorea, 16499
- Ajou University Hospital ( Site 3006)
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North Chungcheong
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Cheongju-si, North Chungcheong, Sydkorea, 28644
- Chungbuk National University Hospital ( Site 3011)
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Pusan-Kwangyokshi
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Busan, Pusan-Kwangyokshi, Sydkorea, 49201
- Dong-A University Hospital ( Site 3013)
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Busan, Pusan-Kwangyokshi, Sydkorea, 49241
- Pusan National University Hospital-Internal Medicine ( Site 3012)
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Haeundae-gu, Pusan-Kwangyokshi, Sydkorea, 48108
- Inje University Haeundae Paik Hospital ( Site 3010)
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Taegu-Kwangyokshi
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Daegu, Taegu-Kwangyokshi, Sydkorea, 42601
- Keimyung University Dongsan Hospital CRC room 1 ( Site 3003)
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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, Turkiet (Türkiye), 06800
- Ankara Bilkent Şehir Hastanesi-cardiology ( Site 2501)
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Eskişehir, Turkiet (Türkiye), 26480
- Eskisehir Osmangazi University-Cardiology ( Site 2510)
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Kayseri, Turkiet (Türkiye), 380280
- Erciyes Universitesi Tıp Fakultesi Hastaneleri-endocrine ( Site 2522)
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Kocaeli, Turkiet (Türkiye), 41380
- Kocaeli Üniversitesi-Cardiology ( Site 2516)
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Ankara
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Altindağ, Ankara, Turkiet (Türkiye), 06230
- Hacettepe Universite Hastaneleri ( Site 2500)
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İzmir
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Bornova, İzmir, Turkiet (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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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Enlicitide Decanoate
Participants will receive 20 mg of enlicitide decanoate orally once daily (QD) for up to 52 weeks. |
Oral tablet
Andra namn:
|
|
Placebo-jämförare: Placebo
Participants will receive enlicitide decanoate-matching placebo orally QD for up to 52 weeks. |
Oral tablet |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Mean Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24
Tidsram: 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)
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Mean Percent Change From Baseline in LDL-C at Week 52
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Medical Director, Merck Sharp & Dohme LLC
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
10 augusti 2023
Primärt slutförande (Faktisk)
28 juli 2025
Avslutad studie (Faktisk)
28 juli 2025
Studieregistreringsdatum
Först inskickad
10 juli 2023
Först inskickad som uppfyllde QC-kriterierna
10 juli 2023
Första postat (Faktisk)
19 juli 2023
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
24 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
28 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Metabolism, medfödda fel
- Genetiska sjukdomar, medfödda
- Metaboliska sjukdomar
- Hyperlipidemier
- Dyslipidemier
- Lipidmetabolismstörningar
- Lipidmetabolism, medfödda fel
- Hyperlipoproteinemier
- Medfödda, ärftliga och neonatala sjukdomar och abnormiteter
- Närings- och metabola sjukdomar
- Hyperkolesterolemi
- Hyperlipoproteinemi typ II
- MK-0616
Andra studie-ID-nummer
- 0616-013
- MK-0616-013 (Annan identifierare: MSD)
- U1111-1285-4164 (Registeridentifierare: UTN)
- jRCT2031230320 (Registeridentifierare: Japan Registry of Clinical Trials (jRCT))
- 2022-502777-42-01 (Registeridentifierare: EU CT)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .