Clinical trial NCT05952856: A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-013) CORALreef Lipids
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-0616 in Adults With Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Hypercholesterolemia
Familial Hypercholesterolemia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2023-07-19
Enrollment: 2760
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24
timeFrame: Baseline and Week 24
measure: Number of participants with one or more adverse events (AEs)
timeFrame: Up to ~60 weeks
measure: Number of participants who discontinue study drug due to an AE
timeFrame: Up to ~52 weeks
Secondary outcomes:
measure: Mean percent change from baseline in LDL-C at Week 52
timeFrame: Baseline and Week 52
measure: Mean percent change from baseline in non-high-density lipoprotein cholesterol (non-HDL-C) at Week 24
timeFrame: Baseline and Week 24
measure: Mean percent change from baseline in apolipoprotein B (ApoB) at Week 24
timeFrame: Baseline and Week 24
measure: Percent change from baseline in lipoprotein(a) (Lp[a]) at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of participants with LDL-C <70 mg/dL and ≥50% reduction from baseline at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of participants with LDL-C <55 mg/dL and ≥50% reduction from baseline at Week 24
timeFrame: Baseline and Week 24
Other outcomes:
Locations:
city: Daphne
country: United States
facility: Alliance for Multispecialty Research, LLC ( Site 0093)
state: Alabama
city: Foley
country: United States
facility: G&L Research ( Site 0043)
state: Alabama
city: Phoenix
country: United States
facility: Synexus Clinical Research US, Inc.-Synexus Clinical Research US, Inc - Central Phoenix ( Site 0084)
state: Arizona
city: Banning
country: United States
facility: Velocity Clinical Research, Banning ( Site 0017)
state: California
city: Beverly Hills
country: United States
facility: National Heart Institute-Research ( Site 0087)
state: California
city: Sacramento
country: United States
facility: Clinical Trials Research ( Site 0115)
state: California
city: Washington
country: United States
facility: Emerson Clinical Research Institute ( Site 0118)
state: District of Columbia
city: Boca Raton
country: United States
facility: Excel Medical Clinical Trials ( Site 0053)
state: Florida
city: Coral Gables
country: United States
facility: Alliance for Multispecialty Research, LLC ( Site 0088)
state: Florida
city: Fort Myers
country: United States
facility: Alliance for Multispecialty Research, LLC ( Site 0094)
state: Florida
city: Hallandale Beach
country: United States
facility: Velocity Clinical Research, Hallandale Beach ( Site 0018)
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research ( Site 0049)
state: Florida
city: Miramar
country: United States
facility: South Broward Research ( Site 0051)
state: Florida
city: Tampa
country: United States
facility: Clinical Research Trials of Florida ( Site 0063)
state: Florida
city: Macon
country: United States
facility: East Coast Institute for Research, LLC ( Site 0033)
state: Georgia
city: Flossmoor
country: United States
facility: Healthcare Research Network - Chicago ( Site 0052)
state: Illinois
city: Evansville
country: United States
facility: Synexus Clinical Research US - Evansville ( Site 0109)
state: Indiana
city: Indianapolis
country: United States
facility: Midwest Institute For Clinical Research ( Site 0059)
state: Indiana
city: Lexington
country: United States
facility: Alliance for Multispecialty Research, LLC ( Site 0028)
state: Kentucky
city: Louisville
country: United States
facility: L-MARC Research Center ( Site 0001)
state: Kentucky
city: Slidell
country: United States
facility: Velocity Clinical Research, Slidell ( Site 0068)
state: Louisiana
city: Rockville
country: United States
facility: Velocity Clinical Research Rockville ( Site 0082)
state: Maryland
city: Gulfport
country: United States
facility: Velocity Clinical Research, Gulfport ( Site 0039)
state: Mississippi
city: Hazelwood
country: United States
facility: Healthcare Research Network - St. Louis ( Site 0054)
state: Missouri
city: Las Vegas
country: United States
facility: Jubilee Clinical Research ( Site 0106)
state: Nevada
city: Las Vegas
country: United States
facility: AB Clinical Trials ( Site 0070)
state: Nevada
city: Albuquerque
country: United States
facility: New Mexico Clinical Research & Osteoporosis Center ( Site 0005)
state: New Mexico
city: East Syracuse
country: United States
facility: Velocity Clinical Research, Syracuse ( Site 0021)
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai-Cardiology ( Site 0002)
state: New York
city: Fargo
country: United States
facility: Lillestol Research ( Site 0026)
state: North Dakota
city: Duncansville
country: United States
facility: altoona center for clinical research ( Site 0089)
state: Pennsylvania
city: Yardley
country: United States
facility: Cardiology Consultants of Philadelphia Yardley ( Site 0097)
state: Pennsylvania
city: Fort Mill
country: United States
facility: Piedmont Research Partners ( Site 0090)
state: South Carolina
city: Greenville
country: United States
facility: Velocity Clinical Research, Greenville ( Site 0023)
state: South Carolina
city: North Charleston
country: United States
facility: Coastal Carolina Research Center ( Site 0006)
state: South Carolina
city: Rapid City
country: United States
facility: Monument Health Clinical Research, a department of Monument -Monument Health Clinical Research, a d
state: South Dakota
city: Kingsport
country: United States
facility: Holston Medical Group ( Site 0048)
state: Tennessee
city: Knoxville
country: United States
facility: Alliance for Multispecialty Research, LLC ( Site 0008)
state: Tennessee
city: Dallas
country: United States
facility: Velocity Clinical Research, Dallas ( Site 0114)
state: Texas
city: Houston
country: United States
facility: Center for Cardiometabolic Disease Prevention/Baylor College of Medicine ( Site 0111)
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, LLC ( Site 0103)
state: Texas
city: Salt Lake City
country: United States
facility: Synexus Clinical Research US, Inc. ( Site 0110)
state: Utah
city: West Jordan
country: United States
facility: Velocity Clinical Research, Salt Lake City ( Site 0019)
state: Utah
city: Manassas
country: United States
facility: Manassas Clinical Research Center ( Site 0007)
state: Virginia
city: Newport News
country: United States
facility: Health Research of Hampton Roads, Inc. ( Site 0044)
state: Virginia
city: Norfolk
country: United States
facility: Alliance for Multispecialty Research, LLC ( Site 0101)
state: Virginia
city: Richmond
country: United States
facility: National Clinical Research, Inc ( Site 0061)
state: Virginia
city: Suffolk
country: United States
facility: Centricity Research Suffolk Primary Care ( Site 0092)
state: Virginia
city: Renton
country: United States
facility: Rainier Clinical Research Center ( Site 0116)
state: Washington
city: Caba
country: Argentina
facility: CEDIC ( Site 0612)
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Centro de Investigaciones Metabólicas (CINME)-Cardiology ( Site 0620)
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Instituto de Investigaciones Clínicas Mar del Plata ( Site 0605)
state: Buenos Aires
city: Zárate
country: Argentina
facility: Instituto de Investigaciones Clinicas Zarate ( Site 0600)
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0604)
state: Caba
city: Buenos Aires
country: Argentina
facility: Fundación Respirar ( Site 0610)
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University-Cardiovascular ( Site 3300)
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital Affiliate of Capital University-Cardiology ( Site 3303)
state: Beijing
city: Chongqing
country: China
facility: 2nd Affiliated Hospital Chongqing Medical Universi ( Site 3320)
state: Chongqing
city: Chongqing
country: China
facility: Chongqing University Three Gorges Hospital ( Site 3321)
state: Chongqing
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital-Cardiology ( Site 3304)
state: Guangdong
city: Guangzhou
country: China
facility: Zhujiang Hospital ( Site 3329)
state: Guangdong
city: Huizhou
country: China
facility: Huizhou Municipal Central Hospital ( Site 3379)
state: Guangdong
city: Shenzhen
country: China
facility: The University of Hong Kong-Shenzhen Hospital-Cardiovascular department ( Site 3318)
state: Guangdong
city: Jingzhou
country: China
facility: Jingzhou Central Hospital-Cardiology ( Site 3376)
state: Hubei
city: Wuhan
country: China
facility: Wuhan Fourth Hospital ( Site 3356)
state: Hubei
city: ChangSha
country: China
facility: Hunan Provincial People's Hospital-Cardiology ( Site 3317)
state: Hunan
city: Changzhou
country: China
facility: Changzhou Second People's Hospital-Cardiology ( Site 3373)
state: Jiangsu
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital ( Site 3308)
state: Jiangsu
city: Nanchang
country: China
facility: The Third Hospital of Nanchang - Fuhe-cardiology ( Site 3378)
state: Jiangxi
city: Siping
country: China
facility: Siping Central People's Hospital-Cardiovascular Department ( Site 3311)
state: Jilin
city: Xianyang
country: China
facility: Xianyang Hospital of Yan'an University ( Site 3340)
state: Shaanxi
city: Chengdu
country: China
facility: Chengdu Second Municipal People's Hospital ( Site 3332)
state: Sichuan
city: Lishui
country: China
facility: People's Hospital of Lishui City-department of cardiovascular ( Site 3302)
state: Zhejiang
city: Medellín
country: Colombia
facility: Fundación Centro de Investigación Clínica CIC ( Site 0906)
state: Antioquia
city: Barranquilla
country: Colombia
facility: Ciensalud Ips S A S ( Site 0903)
state: Atlantico
city: Barranquilla
country: Colombia
facility: Clinica de la Costa S.A.S. ( Site 0902)
state: Atlantico
city: Bogotá
country: Colombia
facility: Salud SURA Calle 100 ( Site 0918)
state: Cundinamarca
city: Zipaquira
country: Colombia
facility: Healthy Medical Center S.A.S ( Site 0913)
state: Cundinamarca
city: Cali
country: Colombia
facility: Fundación Valle del Lili ( Site 0904)
state: Valle Del Cauca
city: Essen
country: Germany
facility: Unterfrintroper Hausarztzentrum Klinische Forschung ( Site 1542)
state: Nordrhein-Westfalen
city: Hohenmölsen
country: Germany
facility: Hausarzt- und Diabetologische Schwerpunktpraxis Hohenmölsen - Weiβenfels ( Site 1527)
state: Sachsen-Anhalt
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus Dresden-Universitätsstudienzentrum für Stoffwechselerkranku
state: Sachsen
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka ( Site 1530)
state: Thuringen
city: Berlin
country: Germany
facility: Velocity Clinical Research GmbH Berlin ( Site 1502)
city: Berlin
country: Germany
facility: Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 1533)
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center ( Site 1705)
city: Haifa
country: Israel
facility: Rambam Health Care Campus-internal department ( Site 1718)
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center ( Site 1710)
city: Jerusalem
country: Israel
facility: Hadassah Medical Center ( Site 1706)
city: Jerusalem
country: Israel
facility: Hadassah Medical Center ( Site 1709)
city: Kfar Saba
country: Israel
facility: Meir Medical Center ( Site 1714)
city: Petah Tikva
country: Israel
facility: Rabin Medical Center ( Site 1720)
city: Ramat Gan
country: Israel
facility: Sheba Medical Center ( Site 1708)
city: Zerifin
country: Israel
facility: Yitzhak Shamir Medical Center. ( Site 1712)
city: Rome
country: Italy
facility: Fondazione Policlinico Tor Vergata ( Site 1809)
state: Lazio
city: Milan
country: Italy
facility: Centro Cardiologico Monzino ( Site 1804)
state: Milano
city: Milan
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda-Unità Ricerche Cliniche della Cardiologia 4 ( Site 1811)
state: Milano
city: Torino
country: Italy
facility: Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino ( Site 1801)
state: Piemonte
city: Rome
country: Italy
facility: Azienda Ospedaliera Sant'Andrea-Department of Clinical and Molecular Medicine ( Site 1807)
state: Roma
city: Catania
country: Italy
facility: Azienda Ospedaliera Garibaldi ( Site 1810)
city: Kitakyusyu-shi
country: Japan
facility: Hirohata Naika Clinic ( Site 3513)
state: Fukuoka
city: Naka
country: Japan
facility: Nakakinen clinic ( Site 3510)
state: Ibaraki
city: Ushiku
country: Japan
facility: Noritake Clinic ( Site 3512)
state: Ibaraki
city: Kanazawa
country: Japan
facility: National Hospital Organization Kanazawa Medical Center ( Site 3508)
state: Ishikawa
city: Morioka
country: Japan
facility: Hirano Medical Clinic ( Site 3522)
state: Iwate
city: Sendai
country: Japan
facility: Shirai Healthcare Clinic Izumichuou ( Site 3527)
state: Miyagi
city: Izumisano
country: Japan
facility: Rinku General Medical Center ( Site 3503)
state: Osaka
city: Kashiwara
country: Japan
facility: Shiraiwa Medical Clinic ( Site 3514)
state: Osaka
city: Suita-shi
country: Japan
facility: Medical Corporation Heishinkai OCROM Clinic ( Site 3501)
state: Osaka
city: Iruma
country: Japan
facility: Saitama Medical University Hospital ( Site 3506)
state: Saitama
city: Bunkyo-ku
country: Japan
facility: Teramoto Medical and Dental Clinic ( Site 3507)
state: Tokyo
city: Chuo-ku
country: Japan
facility: Tokyo-Eki Center-building Clinic ( Site 3505)
state: Tokyo
city: Chuo-ku
country: Japan
facility: Fukuwa Clinic ( Site 3504)
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Teikyo University Hospital ( Site 3500)
state: Tokyo
city: Katsushika-ku
country: Japan
facility: Kato Clinic of Internal Medicine ( Site 3509)
state: Tokyo
city: Mitaka
country: Japan
facility: Kanno Naika ( Site 3511)
state: Tokyo
city: Nerima-ku
country: Japan
facility: Sugawara Clinic ( Site 3519)
state: Tokyo
city: Ota-ku
country: Japan
facility: Shin Clinic - Tokyo - Nishikamata ( Site 3517)
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Heishinkai Medical Group ToCROM Clinic ( Site 3502)
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Mitsukoshi Health and Welfare Foundation ( Site 3521)
state: Tokyo
city: Fukuoka
country: Japan
facility: Medical Corporation Hakuaikai Wellness Tenjin Clinic ( Site 3520)
city: Hiroshima
country: Japan
facility: Hiroshima City Hospital ( Site 3518)
city: Tokyo
country: Japan
facility: Mishuku Hospital ( Site 3524)
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital ( Site 3011)
state: Chungbuk
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital ( Site 3008)
state: Kang-won-do
city: Gwangju-si
country: Korea, Republic of
facility: Chonnam National University Hospital ( Site 3014)
state: Kwangju-Kwangyokshi
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital ( Site 3005)
state: Kyonggi-do
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital ( Site 3006)
state: Kyonggi-do
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital ( Site 3013)
state: Pusan-Kwangyokshi
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital-Internal Medicine ( Site 3012)
state: Pusan-Kwangyokshi
city: Haeundae-gu
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital ( Site 3010)
state: Pusan-Kwangyokshi
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital ( Site 3003)
state: Taegu-Kwangyokshi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital ( Site 3001)
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital ( Site 3009)
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System ( Site 3002)
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center ( Site 3004)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center-cardiology ( Site 3000)
city: Seoul
country: Korea, Republic of
facility: The Catholic Univ. of Korea Seoul St. Mary's Hospital-cardiology ( Site 3007)
city: Cdmx
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 1071)
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Instituto Jalisciense de Investigacion en Diabetes y Obesidad-Endocrinology ( Site 1057)
state: Jalisco
city: Bloemfontein
country: South Africa
facility: IATROS INTERNATIONAL ( Site 2247)
state: Free State
city: Johannesburg
country: South Africa
facility: Soweto Clinical Trials Centre ( Site 2242)
state: Gauteng
city: Johannesburg
country: South Africa
facility: Charlotte Maxeke Johannesburg Academic Hospital-WCR-LIPIDS ( Site 2241)
state: Gauteng
city: Bellville, Cape Town
country: South Africa
facility: Tiervlei Trial Centre-Clinical ( Site 2246)
state: Western Cape
city: Cape Town
country: South Africa
facility: TREAD Research ( Site 2253)
state: Western Cape
city: Cape Town
country: South Africa
facility: University of Cape Town (UCT)-Medicine, Division of Lipidology ( Site 2259)
state: Western Cape
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena ( Site 2352)
state: Andalucia
city: Centelles
country: Spain
facility: EBA CENTELLES ( Site 2311)
state: Cataluna
city: A Coruña
country: Spain
facility: Hospital Abente y Lago ( Site 2356)
state: La Coruna
city: Santiago de Compostela
country: Spain
facility: CHUS - Hospital Clinico Universitario-Cardiology - Clinical Research Unit ( Site 2320)
state: La Coruna
city: Alcorcón
country: Spain
facility: Hospital Universitario Fundacion ALcorcon-Endocrinologia y Nutrición ( Site 2316)
state: Madrid, Comunidad De
city: Pozuelo de Alarcón
country: Spain
facility: HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-Endocrinologia y Nutrición ( Site 2344)
state: Madrid
city: Castilleja de la Cuesta
country: Spain
facility: Vithas Hospital Sevilla-Unidad de Salud Metabólica. Diabetes y Obesidad ( Site 2349)
state: Sevilla
city: Valencia
country: Spain
facility: HOSPITAL CLINICO DE VALENCIA-CARDIOLOGY ( Site 2321)
state: Valenciana, Comunitat
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre-Internal Medicine. Unidad de Ensayos Clínicos ( Site 2319)
city: Changhua County
country: Taiwan
facility: Changhua Christian Hospital ( Site 3101)
state: Changhua
city: Kaohsiung Niao Sung Dist
country: Taiwan
facility: Chang Gung Memorial Hospital at Kaohsiung ( Site 3102)
state: Kaohsiung
city: Tainan City
country: Taiwan
facility: Chi Mei Medical Center-Cardiology ( Site 3104)
state: Tainan
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital-Internal Medicine ( Site 3107)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 3100)
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital-Cardiology ( Site 3108)
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital ( Site 3106)
city: Altindağ
country: Turkey
facility: Hacettepe Universite Hastaneleri ( Site 2500)
state: Ankara
city: Bornova
country: Turkey
facility: Ege Universitesi Hastanesi-Cardilogy Department ( Site 2502)
state: Izmir
city: Ankara
country: Turkey
facility: Ankara Bilkent Şehir Hastanesi-cardiology ( Site 2501)
city: Eskisehir
country: Turkey
facility: Eskisehir Osmangazi University-Cardiology ( Site 2510)
city: Kayseri
country: Turkey
facility: Erciyes Universitesi Tıp Fakultesi Hastaneleri-endocrine ( Site 2522)
city: Kocaeli
country: Turkey
facility: Kocaeli Üniversitesi-Cardiology ( Site 2516)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: