A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017) CORALreef HeFH
- Conditions
- HypercholesterolemiaFamilial Hypercholesterolemia
- Interventions
- Drug: Placebo
- Registration Number
- NCT05952869
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The goal of this study is to evaluate the efficacy, safety, and tolerability of enlicitide decanoate in adult participants with heterozygous familial 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 303
- Has possible or definite diagnosis of heterozygous familial hypercholesterolemia (HeFH) based on a locally accepted diagnostic algorithm
- Has an LDL-C ≥55 mg/dL or ≥70 mg/dL depending on medical history
- Is treated with a moderate- or high-intensity statin medication
- Is on a stable dose of all background lipid-lowering therapies (LLTs) with no planned medication change
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants will receive enlicitide decanoate-matching placebo orally QD for up to 52 weeks. Enlicitide Decanoate Enlicitide Decanoate Participants will receive 20 mg of enlicitide decanoate orally once daily (QD) for up to 52 weeks.
- Primary Outcome Measures
Name Time Method Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24 Baseline and Week 24 Blood samples will be collected at baseline and at Week 24 to assess mean percent change in LDL-C.
Number of participants with one or more adverse events (AEs) 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.
Number of participants who discontinue study drug due to an AE 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.
- Secondary Outcome Measures
Name Time Method Mean percent change from baseline in LDL-C at Week 52 Baseline and Week 52 Blood samples will be collected at baseline and at Week 52 to assess mean percent change in LDL-C.
Mean percent change from baseline in non-high-density lipoprotein cholesterol (HDL-C) at Week 24 Baseline and Week 24 Blood samples will be collected at baseline and at Week 24 to assess mean percent change in non-HDL-C.
Mean percent change from baseline in apolipoprotein B (ApoB) at Week 24 Baseline and Week 24 Blood samples will be collected at baseline and at Week 24 to assess mean percent change in ApoB.
Percent change from baseline in lipoprotein(a) (Lp[a]) at Week 24 Baseline and Week 24 Blood samples will be collected at baseline and at Week 24 to assess percent change in Lp(a).
Percentage of participants with LDL-C <70 mg/dL and ≥50% reduction from baseline at Week 24 Baseline and 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.
Percentage of participants with LDL-C <55 mg/dL and ≥50% reduction from baseline at Week 24 Baseline and 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.
Trial Locations
- Locations (59)
National University Hospital-Department of Medicine ( Site 3212)
🇸🇬Singapore, Central Singapore, Singapore
Velocity Clinical Research at The Pioneer Heart Institute, Lincoln ( Site 0026)
🇺🇸Lincoln, Nebraska, United States
Incor - Instituto do Coracao ( Site 0703)
🇧🇷Sao Paulo, Brazil
Instituto Dante Pazzanese de Cardiology-Fundação Adib Jatene ( Site 0701)
🇧🇷São Paulo, Sao Paulo, Brazil
Royal Prince Alfred Hospital-6West CV Ambulatory Care ( Site 2808)
🇦🇺Camperdown, New South Wales, Australia
Fakultní nemocnice Brno Bohunice-Interni kardiologicka klinika ( Site 3602)
🇨🇿Brno, Brno-mesto, Czechia
Universitair Medisch Centrum Utrecht-Vascular Medicine Research ( Site 1955)
🇳🇱Utrecht, Netherlands
Diex Recherche Trois-Rivieres ( Site 0513)
🇨🇦Trois-Rivieres, Quebec, Canada
Franciscan Physician Network - Indiana Heart Physicians ( Site 0040)
🇺🇸Indianapolis, Indiana, United States
Health Research of Hampton Roads, Inc. ( Site 0020)
🇺🇸Newport News, Virginia, United States
Jubilee Clinical Research ( Site 0030)
🇺🇸Las Vegas, Nevada, United States
Fundación Centro de Investigación Clínica CIC ( Site 0906)
🇨🇴Medellín, Antioquia, Colombia
Hospital de Sant Joan Despí Moisès Broggi ( Site 2335)
🇪🇸Sant Joan Despí, Cataluna, Spain
Ciensalud Ips S A S ( Site 0903)
🇨🇴Barranquilla, Atlantico, Colombia
Rabin Medical Center ( Site 1717)
🇮🇱Petah Tikva, Israel
HOSPITAL CLINICO DE VALENCIA ( Site 2321)
🇪🇸Valencia, Valenciana, Comunitat, Spain
Oslo Universitetssykehus Aker-Lipidklinikken ( Site 2000)
🇳🇴Oslo, Norway
National Cheng Kung University Hospital-Internal Medicine ( Site 3107)
🇨🇳Tainan, Taiwan
SALUT SANT JOAN DE REUS-BAIX CAMP (EDP)-Vascular and Metabolism Unit ( Site 2329)
🇪🇸Reus, Tarragona, Spain
National Taiwan University Hospital ( Site 3100)
🇨🇳Taipei, Taiwan
Pontificia Universidad Catolica de Chile-CICUC ( Site 0812)
🇨🇱Santiago, Region M. De Santiago, Chile
Victorian Heart Hospital-Monash Cardiovascular Research Centre (MCRC) ( Site 2803)
🇦🇺Clayton, Victoria, Australia
Radboudumc-internal medicine ( Site 1952)
🇳🇱Nijmegen, Gelderland, Netherlands
Semmelweis Egyetem-Városmajori Szív- és Érgyógyászati Klinika ( Site 1600)
🇭🇺Budapest, Hungary
Clinica de la Costa S.A.S. ( Site 0902)
🇨🇴Barranquilla, Atlantico, Colombia
Mackay Memorial Hospital -Tamshui Branch ( Site 3109)
🇨🇳New Taipei City, New Taipei, Taiwan
Changi General Hospital ( Site 3211)
🇸🇬Singapore, Central Singapore, Singapore
Meilahden tornisairaala - Meilahti Tower Hospital ( Site 1300)
🇫🇮Helsinki, Uusimaa, Finland
CDIEM ( Site 0814)
🇨🇱Providencia, Region M. De Santiago, Chile
Clinical Research Chile SpA ( Site 0804)
🇨🇱Valdivia, Los Rios, Chile
Enroll SpA ( Site 0803)
🇨🇱Santiago, Region M. De Santiago, Chile
Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Anyagcsere Tanszék) ( Site 1601)
🇭🇺Debrecen, Hungary
Salud SURA Calle 100 ( Site 0918)
🇨🇴Bogotá, Cundinamarca, Colombia
Queen Mary Hospital-Medical ( Site 3300)
🇭🇰Pok Fu Lam, Hong Kong
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Belgyógyászati Klinika ( Site 1603)
🇭🇺Szeged, Csongrad, Hungary
Shin Kong Wu Ho-Su Memorial Hospital ( Site 3106)
🇨🇳Taipei City, Taipei, Taiwan
Universidade Federal Do Ceara ( Site 0702)
🇧🇷Fortaleza, Ceara, Brazil
Alliance for Multispecialty Research, LLC ( Site 0023)
🇺🇸Daphne, Alabama, United States
Advanced Pharma Research ( Site 0007)
🇺🇸Cutler Bay, Florida, United States
Excel Medical Clinical Trials ( Site 0008)
🇺🇸Boca Raton, Florida, United States
Clinical Site Partners LLC, dba CSP Orlando ( Site 0028)
🇺🇸Winter Park, Florida, United States
Velocity Clinical Research, Salt Lake City ( Site 0004)
🇺🇸West Jordan, Utah, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0001)
🇺🇸Troy, Michigan, United States
Wake Forest Baptist Health-Cardiovascular Medicine ( Site 0041)
🇺🇸Winston-Salem, North Carolina, United States
Ecogene-21 ( Site 0510)
🇨🇦Chicoutimi, Quebec, Canada
Institut de Cardiologie de Montreal ( Site 0506)
🇨🇦Montreal, Quebec, Canada
Fakultni Nemocnice u sv. Anny v Brne ( Site 3604)
🇨🇿Brno, Jihomoravsky Kraj, Czechia
Shaare Zedek Medical Center ( Site 1710)
🇮🇱Jerusalem, Israel
Clalit Health Services - Sakhnin Community Clinic-Research Unit ( Site 1700)
🇮🇱Sakhnin, Israel
Vasculair Onderzoek Centrum Hoorn ( Site 1953)
🇳🇱Hoorn, Noord-Holland, Netherlands
Amsterdam UMC, locatie AMC-Vascular Medicine Clin Trial Unit ( Site 1954)
🇳🇱Amsterdam, Noord-Holland, Netherlands
Pacific Clinical Research Network - Rotorua ( Site 2902)
🇳🇿Rotorua, Bay Of Plenty, New Zealand
Institut Klinicke a Experimentalni Mediciny ( Site 3601)
🇨🇿Praha, Praha 4, Czechia
Progressive Medical Research ( Site 0021)
🇺🇸Port Orange, Florida, United States
Synexus Clinical Research US - Evansville ( Site 0031)
🇺🇸Evansville, Indiana, United States
Hadassah Medical Center ( Site 1709)
🇮🇱Jerusalem, Israel
Nordlandssykehuset ( Site 2001)
🇳🇴Bodø, Nordland, Norway
New Zealand Clinical Research (Christchurch) ( Site 2901)
🇳🇿Christchurch, Canterbury, New Zealand
Prince of Wales Hospital ( Site 3304)
🇭🇰Shatin, Hong Kong