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MK-0616（口服 PCSK9 抑制剂）治疗成人高胆固醇血症的研究 (MK-0616-013)

2026年8月28日更新者：Merck Sharp & Dohme LLC

一项评估 MK-0616 对成人高胆固醇血症疗效和安全性的 3 期、随机、双盲、安慰剂对照研究

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.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

2912

阶段

第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

中国
- Beijing Municipality
  - Beijing、Beijing Municipality、中国、100029
    - Beijing Anzhen Hospital, Capital Medical University-Cardiovascular ( Site 3300)
  - Beijing、Beijing Municipality、中国、100050
    - Beijing Friendship Hospital Affiliate of Capital University-Cardiology ( Site 3303)
- Chongqing Municipality
  - Chongqing、Chongqing Municipality、中国、400072
    - The Second Affiliated Hospital of Chongqing Medical University ( Site 3320)
  - Chongqing、Chongqing Municipality、中国、404000
    - Chongqing University Three Gorges Hospital ( Site 3321)
- Guangdong
  - Guangzhou、Guangdong、中国、510080
    - Guangdong Provincial People's Hospital-Cardiology ( Site 3304)
  - Guangzhou、Guangdong、中国、510280
    - Zhujiang Hospital of Southern Medical University ( Site 3329)
  - Huizhou、Guangdong、中国、516001
    - Huizhou Municipal Central Hospital ( Site 3379)
  - Shenzhen、Guangdong、中国、518053
    - The University of Hong Kong-Shenzhen Hospital-Cardiovascular department ( Site 3318)
- Hubei
  - Jingzhou、Hubei、中国、434036
    - Jingzhou Central Hospital-Cardiology ( Site 3376)
  - Wuhan、Hubei、中国、430030
    - Wuhan Fourth Hospital ( Site 3356)
- Hunan
  - Changsha、Hunan、中国、410005
    - Hunan Provincial People's Hospital-Cardiology ( Site 3317)
- Jiangsu
  - Changzhou、Jiangsu、中国、213000
    - Changzhou Second People's Hospital-Cardiology ( Site 3373)
  - Yangzhou、Jiangsu、中国、225001
    - Northern Jiangsu People's Hospital ( Site 3308)
- Jiangxi
  - Nanchang、Jiangxi、中国、330003
    - The Third Hospital of Nanchang - Fuhe-cardiology ( Site 3378)
- Jilin
  - Siping、Jilin、中国、136000
    - Siping Central People's Hospital-Cardiovascular Department ( Site 3311)
- Shaanxi
  - Xianyang、Shaanxi、中国、712000
    - Xianyang Hospital of Yan'an University ( Site 3340)
- Sichuan
  - Chengdu、Sichuan、中国、610021
    - Chengdu Second Municipal People's Hospital ( Site 3332)
- Zhejiang
  - Lishui、Zhejiang、中国、323000
    - People's Hospital of Lishui City-department of cardiovascular ( Site 3302)
以色列
- - Hadera、以色列、3810101
    - Hillel Yaffe Medical Center ( Site 1705)
  - Haifa、以色列、3109601
    - Rambam Health Care Campus-internal department ( Site 1718)
  - Jerusalem、以色列、9103102
    - Shaare Zedek Medical Center ( Site 1710)
  - Jerusalem、以色列、9112001
    - Hadassah Medical Center ( Site 1709)
  - Jerusalem、以色列、9112001
    - Hadassah Medical Center ( Site 1706)
  - Kfar Saba、以色列、4428164
    - Meir Medical Center. ( Site 1714)
  - Petah Tikva、以色列、4941 492
    - Rabin Medical Center ( Site 1720)
  - Ramat Gan、以色列、5265601
    - Sheba Medical Center ( Site 1708)
  - Tsrifin、以色列、7033001
    - Yitzhak Shamir Medical Center. ( Site 1712)
南非
- Free State
  - Bloemfontein、Free State、南非、9301
    - IATROS INTERNATIONAL ( Site 2247)
- Gauteng
  - Johannesburg、Gauteng、南非、1818
    - Soweto Clinical Trials Centre ( Site 2242)
  - Johannesburg、Gauteng、南非、2193
    - Charlotte Maxeke Johannesburg Academic Hospital-WCR-LIPIDS ( Site 2241)
- Western Cape
  - Bellville, Cape Town、Western Cape、南非、7530
    - Tiervlei Trial Centre-Clinical ( Site 2246)
  - Cape Town、Western Cape、南非、7500
    - TREAD Research ( Site 2253)
  - Cape Town、Western Cape、南非、7925
    - University of Cape Town (UCT)-Medicine, Division of Lipidology ( Site 2259)
台湾
- - Changhua、台湾、50006
    - Changhua Christian Hospital ( Site 3101)
  - Kaohsiung City、台湾、83301
    - Chang Gung Memorial Hospital at Kaohsiung ( Site 3102)
  - Tainan、台湾、704
    - National Cheng Kung University Hospital ( Site 3107)
  - Taipei、台湾、10002
    - National Taiwan University Hospital ( Site 3100)
  - Taipei、台湾、110
    - Taipei Medical University Hospital-Cardiology ( Site 3108)
  - Taipei、台湾、112
    - Taipei Veterans General Hospital ( Site 3106)
- Tainan
  - Tainan、Tainan、台湾、71004
    - Chi Mei Medical Center-Cardiology ( Site 3104)
哥伦比亚
- Antioquia
  - Medellín、Antioquia、哥伦比亚、050021
    - Fundación Centro de Investigación Clínica CIC ( Site 0906)
- Atlántico
  - Barranquilla、Atlántico、哥伦比亚、08001
    - Ciensalud Ips S A S ( Site 0903)
  - Barranquilla、Atlántico、哥伦比亚、080020
    - Clinica de la Costa S.A.S. ( Site 0902)
- Cundinamarca
  - Bogotá、Cundinamarca、哥伦比亚、110231
    - Salud SURA Calle 100 ( Site 0918)
  - Zipaquirá、Cundinamarca、哥伦比亚、250252
    - Healthy Medical Center S.A.S ( Site 0913)
- Valle del Cauca Department
  - Cali、Valle del Cauca Department、哥伦比亚、760032
    - Fundación Valle del Lili ( Site 0904)
土耳其（türkiye）
- - Ankara、土耳其（türkiye）、06800
    - Ankara Bilkent Şehir Hastanesi-cardiology ( Site 2501)
  - Eskişehir、土耳其（türkiye）、26480
    - Eskisehir Osmangazi University-Cardiology ( Site 2510)
  - Kayseri、土耳其（türkiye）、380280
    - Erciyes Universitesi Tıp Fakultesi Hastaneleri-endocrine ( Site 2522)
  - Kocaeli、土耳其（türkiye）、41380
    - Kocaeli Üniversitesi-Cardiology ( Site 2516)
- Ankara
  - Altindağ、Ankara、土耳其（türkiye）、06230
    - Hacettepe Universite Hastaneleri ( Site 2500)
- İzmir
  - Bornova、İzmir、土耳其（türkiye）、35100
    - Ege Universitesi Hastanesi-Cardilogy Department ( Site 2502)
墨西哥
- Jalisco
  - Guadalajara、Jalisco、墨西哥、44600
    - Instituto Jalisciense de Investigacion en Diabetes y Obesidad-Endocrinology ( Site 1057)
- Mexico City
  - Mexico City、Mexico City、墨西哥、14080
    - Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 1071)
德国
- - Berlin、德国、10787
    - Velocity Clinical Research GmbH Berlin ( Site 1502)
  - Berlin、德国、12203
    - Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 1533)
- North Rhine-Westphalia
  - Essen、North Rhine-Westphalia、德国、45359
    - Unterfrintroper Hausarztzentrum Klinische Forschung ( Site 1542)
- Saxony
  - Dresden、Saxony、德国、01307
    - Universitaetsklinikum Carl Gustav Carus Dresden-Universitätsstudienzentrum für Stoffwechselerkranku ( Site 1508)
- Saxony-Anhalt
  - Hohenmölsen、Saxony-Anhalt、德国、06679
    - Hausarzt- und Diabetologische Schwerpunktpraxis Hohenmölsen - Weiβenfels ( Site 1527)
- Thuringia
  - Bad Berka、Thuringia、德国、99437
    - Zentralklinik Bad Berka ( Site 1530)
意大利
- - Catania、意大利、95122
    - Azienda Ospedaliera Garibaldi ( Site 1810)
- Lazio
  - Rome、Lazio、意大利、00133
    - Fondazione Policlinico Tor Vergata ( Site 1809)
- Milano
  - Milan、Milano、意大利、20138
    - Centro Cardiologico Monzino ( Site 1804)
  - Milan、Milano、意大利、20162
    - ASST Grande Ospedale Metropolitano Niguarda-Unità Ricerche Cliniche della Cardiologia 4 ( Site 1811)
- Piedmont
  - Turin、Piedmont、意大利、10126
    - Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino ( Site 1801)
- Roma
  - Rome、Roma、意大利、00189
    - Azienda Ospedaliera Sant'Andrea-Department of Clinical and Molecular Medicine ( Site 1807)
日本
- - Fukuoka、日本、810-0001
    - Medical Corporation Hakuaikai Wellness Tenjin Clinic ( Site 3520)
  - Hiroshima、日本、730-8518
    - Hiroshima City Hiroshima Citizens Hospital ( Site 3518)
  - Tokyo、日本、153-0051
    - Mishuku Hospital ( Site 3524)
- Fukuoka
  - Kitakyusyu-shi、Fukuoka、日本、807-0857
    - Hirohata Naika Clinic ( Site 3513)
- Ibaraki
  - Naka、Ibaraki、日本、311-0113
    - Nakakinen clinic ( Site 3510)
  - Ushiku、Ibaraki、日本、300-1207
    - Noritake Clinic ( Site 3512)
- Ishikawa-ken
  - Kanazawa、Ishikawa-ken、日本、920-8650
    - National Hospital Organization Kanazawa Medical Center ( Site 3508)
- Iwate
  - Morioka、Iwate、日本、020-0132
    - Hirano Medical Clinic ( Site 3522)
- Miyagi
  - Sendai、Miyagi、日本、981-3133
    - Shirai Healthcare Clinic Izumichuou ( Site 3527)
- Osaka
  - Izumisano、Osaka、日本、598-8577
    - Rinku General Medical Center ( Site 3503)
  - Kashihara、Osaka、日本、582-0005
    - Shiraiwa Medical Clinic ( Site 3514)
  - Suita-shi、Osaka、日本、565-0853
    - Medical Corporation Heishinkai OCROM Clinic ( Site 3501)
- Saitama
  - Iruma、Saitama、日本、350-0495
    - Saitama Medical University Hospital ( Site 3506)
- Tokyo
  - Bunkyo-ku、Tokyo、日本、113-0033
    - Teramoto Medical and Dental Clinic ( Site 3507)
  - Chuo-ku、Tokyo、日本、103-0027
    - Tokyo-Eki Center-building Clinic ( Site 3505)
  - Chuo-ku、Tokyo、日本、104-0031
    - Fukuwa Clinic ( Site 3504)
  - Katsushika-ku、Tokyo、日本、125-0054
    - Kato Clinic of Internal Medicine ( Site 3509)
  - Mitaka、Tokyo、日本、181-0013
    - Kanno Naika ( Site 3511)
  - Nerima-ku、Tokyo、日本、177-0041
    - Sugawara Clinic ( Site 3519)
  - Shinjuku-ku、Tokyo、日本、160-0008
    - Medical Corporation Heishinkai ToCROM Clinic ( Site 3502)
  - Shinjuku-ku、Tokyo、日本、160-0023
    - Mitsukoshi Health and Welfare Foundation ( Site 3521)
  - tabashi City、Tokyo、日本、173-8606
    - Teikyo University Hospital ( Site 3500)
  - Ōta-ku、Tokyo、日本、144-0051
    - Shin Clinic ( Site 3517)
美国
- Alabama
  - Daphne、Alabama、美国、36526
    - Alliance for Multispecialty Research, LLC ( Site 0093)
  - Foley、Alabama、美国、36535
    - G&L Research ( Site 0043)
- Arizona
  - Phoenix、Arizona、美国、85020
    - Synexus Clinical Research US, Inc.-Synexus Clinical Research US, Inc - Central Phoenix ( Site 0084)
- California
  - Beverly Hills、California、美国、90211
    - National Heart Institute-Research ( Site 0087)
  - Sacramento、California、美国、95821
    - Clinical Trials Research ( Site 0115)
  - San Bernardino、California、美国、92408
    - Velocity Clinical Research, Banning ( Site 0017)
- District of Columbia
  - Washington D.C.、District of Columbia、美国、20009
    - Emerson Clinical Research Institute ( Site 0118)
- Florida
  - Boca Raton、Florida、美国、33434
    - Excel Medical Clinical Trials ( Site 0053)
  - Coral Gables、Florida、美国、33134
    - Alliance for Multispecialty Research, LLC ( Site 0088)
  - Fort Myers、Florida、美国、33912
    - Alliance for Multispecialty Research, LLC ( Site 0094)
  - Hallandale、Florida、美国、33009
    - Velocity Clinical Research, Hallandale Beach ( Site 0018)
  - Jacksonville、Florida、美国、32216
    - Jacksonville Center for Clinical Research ( Site 0049)
  - Miramar、Florida、美国、33027
    - South Broward Research ( Site 0051)
  - Tampa、Florida、美国、33607
    - Clinical Research Trials of Florida ( Site 0063)
- Georgia
  - Macon、Georgia、美国、31210
    - East Coast Institute for Research, LLC ( Site 0033)
- Illinois
  - Flossmoor、Illinois、美国、60422
    - Healthcare Research Network - Chicago ( Site 0052)
- Indiana
  - Evansville、Indiana、美国、47714
    - Synexus Clinical Research US, Inc. ( Site 0109)
  - Indianapolis、Indiana、美国、46260
    - Midwest Institute For Clinical Research ( Site 0059)
- Kentucky
  - Lexington、Kentucky、美国、40509
    - Alliance for Multispecialty Research, LLC ( Site 0028)
  - Louisville、Kentucky、美国、40213
    - L-MARC Research Center ( Site 0001)
- Louisiana
  - Covington、Louisiana、美国、70433
    - Velocity Clinical Research, Covington ( Site 0068)
- Maryland
  - Rockville、Maryland、美国、20854
    - Velocity Clinical Research Rockville ( Site 0082)
- Mississippi
  - Gulfport、Mississippi、美国、39503
    - Velocity Clinical Research, Gulfport ( Site 0039)
- Missouri
  - Hazelwood、Missouri、美国、63042
    - Healthcare Research Network - St. Louis ( Site 0054)
- Nevada
  - Las Vegas、Nevada、美国、89106
    - Jubilee Clinical Research ( Site 0106)
  - Las Vegas、Nevada、美国、89119
    - AB Clinical Trials ( Site 0070)
- New Mexico
  - Albuquerque、New Mexico、美国、87106
    - New Mexico Clinical Research & Osteoporosis Center ( Site 0005)
- New York
  - East Syracuse、New York、美国、13057
    - Velocity Clinical Research, Syracuse ( Site 0021)
  - New York、New York、美国、10029
    - Icahn School of Medicine at Mount Sinai-Cardiology ( Site 0002)
- North Dakota
  - Fargo、North Dakota、美国、58104
    - Lillestol Research ( Site 0026)
- Pennsylvania
  - Duncansville、Pennsylvania、美国、16635
    - altoona center for clinical research ( Site 0089)
  - Yardley、Pennsylvania、美国、19067
    - Cardiology Consultants of Philadelphia Yardley ( Site 0097)
- South Carolina
  - Fort Mill、South Carolina、美国、29707
    - Piedmont Research Partners ( Site 0090)
  - Greenville、South Carolina、美国、29615
    - Velocity Clinical Research, Greenville ( Site 0023)
  - North Charleston、South Carolina、美国、29405
    - Coastal Carolina Research Center ( Site 0006)
- South Dakota
  - Rapid City、South Dakota、美国、57701
    - Monument Health Clinical Research, a department of Monument -Monument Health Clinical Research, a d ( Site 0009)
- Tennessee
  - Kingsport、Tennessee、美国、37660
    - Holston Medical Group ( Site 0048)
  - Knoxville、Tennessee、美国、37920
    - Alliance for Multispecialty Research, LLC ( Site 0008)
- Texas
  - Dallas、Texas、美国、75230
    - Velocity Clinical Research, Dallas ( Site 0114)
  - Houston、Texas、美国、77030
    - Center for Cardiometabolic Disease Prevention/Baylor College of Medicine ( Site 0111)
  - San Antonio、Texas、美国、78229
    - Clinical Trials of Texas, LLC ( Site 0103)
- Utah
  - Salt Lake City、Utah、美国、84106
    - Synexus Clinical Research US, Inc. ( Site 0110)
  - West Jordan、Utah、美国、84088
    - Velocity Clinical Research, Salt Lake City ( Site 0019)
- Virginia
  - Manassas、Virginia、美国、20110
    - Manassas Clinical Research Center ( Site 0007)
  - Newport News、Virginia、美国、23606
    - Health Research of Hampton Roads, Inc. ( Site 0044)
  - Norfolk、Virginia、美国、23502
    - Alliance for Multispecialty Research, LLC ( Site 0101)
  - Richmond、Virginia、美国、23294
    - National Clinical Research, Inc ( Site 0061)
  - Suffolk、Virginia、美国、23435
    - Centricity Research Suffolk Family Medicine ( Site 0092)
- Washington
  - Renton、Washington、美国、98057
    - Rainier Clinical Research Center ( Site 0116)
西班牙
- - Madrid、西班牙、28041
    - Hospital Universitario 12 de Octubre-Internal Medicine. Unidad de Ensayos Clínicos ( Site 2319)
- Andalusia
  - Seville、Andalusia、西班牙、41009
    - Hospital Universitario Virgen Macarena ( Site 2352)
- Catalonia
  - Centelles、Catalonia、西班牙、08500
    - EBA CENTELLES ( Site 2311)
- La Coruna
  - A Coruña、La Coruna、西班牙、15001
    - Hospital Abente y Lago ( Site 2356)
  - Santiago de Compostela、La Coruna、西班牙、15706
    - CHUS - Hospital Clinico Universitario-Cardiology - Clinical Research Unit ( Site 2320)
- Madrid
  - Pozuelo de Alarcón、Madrid、西班牙、28223
    - HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-Endocrinologia y Nutrición ( Site 2344)
- Madrid, Comunidad de
  - Alcorcón、Madrid, Comunidad de、西班牙、28922
    - Hospital Universitario Fundacion ALcorcon-Endocrinologia y Nutrición ( Site 2316)
- Sevilla
  - Castilleja de la Cuesta、Sevilla、西班牙、41950
    - Vithas Hospital Sevilla-Unidad de Salud Metabólica. Diabetes y Obesidad ( Site 2349)
- Valenciana, Comunitat
  - Valencia、Valenciana, Comunitat、西班牙、46010
    - HOSPITAL CLINICO DE VALENCIA-CARDIOLOGY ( Site 2321)
阿根廷
- - CABA、阿根廷、C1056ABI
    - Centro de Investigaciones Metabólicas (CINME)-Cardiology ( Site 0620)
- Buenos Aires
  - CABA、Buenos Aires、阿根廷、C1060ABN
    - CEDIC ( Site 0612)
  - Mar del Plata、Buenos Aires、阿根廷、B7600FZO
    - Instituto de Investigaciones Clínicas Mar del Plata ( Site 0605)
  - Zárate、Buenos Aires、阿根廷、B2800DGH
    - Instituto de Investigaciones Clinicas Zarate ( Site 0600)
- Buenos Aires F.D.
  - Buenos Aires、Buenos Aires F.D.、阿根廷、C1425AGC
    - Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0604)
  - Buenos Aires、Buenos Aires F.D.、阿根廷、C1426ABP
    - Fundación Respirar ( Site 0610)
韩国
- - Seoul、韩国、03080
    - Seoul National University Hospital ( Site 3001)
  - Seoul、韩国、03181
    - Kangbuk Samsung Hospital ( Site 3009)
  - Seoul、韩国、03722
    - Severance Hospital, Yonsei University Health System ( Site 3002)
  - Seoul、韩国、05505
    - Asan Medical Center ( Site 3004)
  - Seoul、韩国、06351
    - Samsung Medical Center-cardiology ( Site 3000)
  - Seoul、韩国、06591
    - The Catholic Univ. of Korea Seoul St. Mary's Hospital-cardiology ( Site 3007)
- Kang-won-do
  - Wŏnju、Kang-won-do、韩国、26426
    - Wonju Severance Christian Hospital ( Site 3008)
- Kwangju-Kwangyokshi
  - Gwangju、Kwangju-Kwangyokshi、韩国、61469
    - Chonnam National University Hospital ( Site 3014)
- Kyonggi-do
  - Seongnam、Kyonggi-do、韩国、13620
    - Seoul National University Bundang Hospital ( Site 3005)
  - Suwon、Kyonggi-do、韩国、16499
    - Ajou University Hospital ( Site 3006)
- North Chungcheong
  - Cheongju-si、North Chungcheong、韩国、28644
    - Chungbuk National University Hospital ( Site 3011)
- Pusan-Kwangyokshi
  - Busan、Pusan-Kwangyokshi、韩国、49201
    - Dong-A University Hospital ( Site 3013)
  - Busan、Pusan-Kwangyokshi、韩国、49241
    - Pusan National University Hospital-Internal Medicine ( Site 3012)
  - Haeundae-gu、Pusan-Kwangyokshi、韩国、48108
    - Inje University Haeundae Paik Hospital ( Site 3010)
- Taegu-Kwangyokshi
  - Daegu、Taegu-Kwangyokshi、韩国、42601
    - Keimyung University Dongsan Hospital CRC room 1 ( Site 3003)

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：随机化
介入模型：并行分配
屏蔽：三倍

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：Enlicitide Decanoate Participants will receive 20 mg of enlicitide decanoate orally once daily (QD) for up to 52 weeks.	药品：Enlicitide Decanoate Oral tablet 其他名称： MK-0616
安慰剂比较：Placebo Participants will receive enlicitide decanoate-matching placebo orally QD for up to 52 weeks.	药品：Placebo Oral tablet

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Mean Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24 大体时间：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) 大体时间：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 大体时间：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

次要结果测量

结果测量	措施说明	大体时间
Mean Percent Change From Baseline in LDL-C at Week 52 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Merck Sharp & Dohme LLC

调查人员

研究主任：Medical Director、Merck Sharp & Dohme LLC

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

Navar AM, Mikhailova E, Catapano AL, Banka P, Blom DJ, Cadena A, Kourpanidis S, Lepor NE, Tsukamoto K, Mendizabal G, Nunez J, Zhang W, Zhu P, Zhuo M, Ballantyne CM; CORALreef Lipids Investigators. A Placebo-Controlled Trial of the Oral PCSK9 Inhibitor Enlicitide. N Engl J Med. 2026 Feb 5;394(6):529-539. doi: 10.1056/NEJMoa2511002.

有用的网址

<p>Merck Clinical Trials Information</p>

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年8月10日

初级完成 (实际的)

2025年7月28日

研究完成 (实际的)

2025年7月28日

研究注册日期

首次提交

2023年7月10日

首先提交符合 QC 标准的

2023年7月10日

首次发布 (实际的)

2023年7月19日

研究记录更新

最后更新发布 (实际的)

2026年9月24日

上次提交的符合 QC 标准的更新

2026年8月28日

最后验证

2026年8月1日

MK-0616（口服 PCSK9 抑制剂）治疗成人高胆固醇血症的研究 (MK-0616-013)

一项评估 MK-0616 对成人高胆固醇血症疗效和安全性的 3 期、随机、双盲、安慰剂对照研究

研究概览

地位

条件

干预/治疗

研究类型

注册 (实际的)

阶段

联系人和位置

学习地点

参与标准

资格标准

适合学习的年龄

接受健康志愿者

有资格学习的性别

描述

学习计划

研究是如何设计的？

设计细节

手臂数量

武器和干预

参与者组/臂

干预/治疗

研究衡量的是什么？

主要结果指标

结果测量

措施说明

大体时间

次要结果测量

结果测量

措施说明

大体时间

合作者和调查者

赞助

调查人员

出版物和有用的链接

一般刊物

有用的网址

研究记录日期

研究主要日期

学习开始 (实际的)

初级完成 (实际的)

研究完成 (实际的)

研究注册日期

首次提交

首先提交符合 QC 标准的

首次发布 (实际的)

研究记录更新

最后更新发布 (实际的)

上次提交的符合 QC 标准的更新

最后验证

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

IPD 计划说明

药物和器械信息、研究文件

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