A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-013) CORALreef Lipids

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-0616 in Adults With Hypercholesterolemia

The goal of this study is to evaluate the efficacy, safety, and tolerability of 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.

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia; Familial Hypercholesterolemia
• Intervention / Treatment: Drug: Placebo; Drug: Enlicitide Decanoate

• Study Type: Interventional
• Enrollment (Actual): 2912
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enlicitide Decanoate; Participants will receive 20 mg of enlicitide decanoate orally once daily (QD) for up to 52 weeks.	Drug: Enlicitide Decanoate; Oral tablet; Other Names: MK-0616
Placebo Comparator: Placebo; Participants will receive enlicitide decanoate-matching placebo orally QD for up to 52 weeks.	Drug: Placebo; Oral tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24	Blood samples will be collected at baseline and at Week 24 to assess mean percent change in LDL-C.	Baseline and Week 24
Number of participants with one or more adverse events (AEs)	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	Up to ~60 weeks
Number of participants who discontinue study drug due to an AE	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	Up to ~52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean percent change from baseline in LDL-C at Week 52	Blood samples will be collected at baseline and at Week 52 to assess mean percent change in LDL-C.	Baseline and Week 52
Mean percent change from baseline in non-high-density lipoprotein cholesterol (non-HDL-C) at Week 24	Blood samples will be collected at baseline and at Week 24 to assess mean percent change in non-HDL-C.	Baseline and Week 24
Mean percent change from baseline in apolipoprotein B (ApoB) at Week 24	Blood samples will be collected at baseline and at Week 24 to assess mean percent change in ApoB.	Baseline and Week 24
Percent change from baseline in lipoprotein(a) (Lp[a]) at Week 24	Blood samples will be collected at baseline and at Week 24 to assess percent change in Lp(a).	Baseline and Week 24
Percentage of participants with LDL-C <70 mg/dL and ≥50% reduction from baseline at Week 24	Blood samples will be collected at baseline and at Week 24 to assess the percentage of participants who have LDL-C <70 mg/dL and ≥50% reduction from baseline.	Baseline and Week 24
Percentage of participants with LDL-C <55 mg/dL and ≥50% reduction from baseline at Week 24	Blood samples will be collected at baseline and at Week 24 to assess the percentage of participants who have LDL-C <55 mg/dL and ≥50% reduction from baseline.	Baseline and Week 24

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information
• Plain Language Summary

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2023
• Primary Completion (Actual): July 28, 2025
• Study Completion (Actual): July 28, 2025

Study Registration Dates

• First Submitted: July 10, 2023
• First Submitted That Met QC Criteria: July 10, 2023
• First Posted (Actual): July 19, 2023

Study Record Updates

• Last Update Posted (Estimated): September 10, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolism, Inborn Errors; Genetic Diseases, Inborn; Metabolic Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Lipid Metabolism, Inborn Errors; Hyperlipoproteinemias; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nutritional and Metabolic Diseases; Hypercholesterolemia; Hyperlipoproteinemia Type II; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs; MK-0616
• Other Study ID Numbers: 0616-013; MK-0616-013 (Other Identifier: MSD); U1111-1285-4164 (Registry Identifier: UTN); jRCT2031230320 (Registry Identifier: Japan Registry of Clinical Trials (jRCT)); 2022-502777-42-00 (Registry Identifier: EU CT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No