Clinical trial NCT05952869: A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017) CORALreef HeFH
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-0616 in Adults With Heterozygous Familial Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Familial Hypercholesterolemia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2023-07-19
Enrollment: 303
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 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.


Eligibility criteria: Inclusion Criteria:

* 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

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

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 (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 0023)
state: Alabama
city: Boca Raton
country: United States
facility: Excel Medical Clinical Trials ( Site 0008)
state: Florida
city: Cutler Bay
country: United States
facility: Advanced Pharma Research ( Site 0007)
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research ( Site 0021)
state: Florida
city: Winter Park
country: United States
facility: Clinical Site Partners LLC, dba CSP Orlando ( Site 0028)
state: Florida
city: Evansville
country: United States
facility: Synexus Clinical Research US - Evansville ( Site 0031)
state: Indiana
city: Indianapolis
country: United States
facility: Franciscan Physician Network - Indiana Heart Physicians ( Site 0040)
state: Indiana
city: Troy
country: United States
facility: Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0001)
state: Michigan
city: Lincoln
country: United States
facility: Velocity Clinical Research at The Pioneer Heart Institute, Lincoln ( Site 0026)
state: Nebraska
city: Las Vegas
country: United States
facility: Jubilee Clinical Research ( Site 0030)
state: Nevada
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health-Cardiovascular Medicine ( Site 0041)
state: North Carolina
city: West Jordan
country: United States
facility: Velocity Clinical Research, Salt Lake City ( Site 0004)
state: Utah
city: Newport News
country: United States
facility: Health Research of Hampton Roads, Inc. ( Site 0020)
state: Virginia
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital-6West CV Ambulatory Care ( Site 2808)
state: New South Wales
city: Clayton
country: Australia
facility: Victorian Heart Hospital-Monash Cardiovascular Research Centre (MCRC) ( Site 2803)
state: Victoria
city: Fortaleza
country: Brazil
facility: Universidade Federal Do Ceara ( Site 0702)
state: Ceara
city: São Paulo
country: Brazil
facility: Instituto Dante Pazzanese de Cardiology-Fundação Adib Jatene ( Site 0701)
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: Incor - Instituto do Coracao ( Site 0703)
city: Chicoutimi
country: Canada
facility: Ecogene-21 ( Site 0510)
state: Quebec
city: Montreal
country: Canada
facility: Institut de Cardiologie de Montreal ( Site 0506)
state: Quebec
city: Trois-Rivieres
country: Canada
facility: Diex Recherche Trois-Rivieres ( Site 0513)
state: Quebec
city: Valdivia
country: Chile
facility: Clinical Research Chile SpA ( Site 0804)
state: Los Rios
city: Providencia
country: Chile
facility: CDIEM ( Site 0814)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Enroll SpA ( Site 0803)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile-CICUC ( Site 0812)
state: Region M. De Santiago
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: Brno
country: Czechia
facility: Fakultní nemocnice Brno Bohunice-Interni kardiologicka klinika ( Site 3602)
state: Brno-mesto
city: Brno
country: Czechia
facility: Fakultni Nemocnice u sv. Anny v Brne ( Site 3604)
state: Jihomoravsky Kraj
city: Praha
country: Czechia
facility: Institut Klinicke a Experimentalni Mediciny ( Site 3601)
state: Praha 4
city: Helsinki
country: Finland
facility: Meilahden tornisairaala - Meilahti Tower Hospital ( Site 1300)
state: Uusimaa
city: Pok Fu Lam
country: Hong Kong
facility: Queen Mary Hospital-Medical ( Site 3300)
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital ( Site 3304)
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Belgyógyászati Klinika ( Site 1603)
state: Csongrad
city: Budapest
country: Hungary
facility: Semmelweis Egyetem-Városmajori Szív- és Érgyógyászati Klinika ( Site 1600)
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Anyagcsere Tanszék) ( Site 1601)
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center ( Site 1710)
city: Jerusalem
country: Israel
facility: Hadassah Medical Center ( Site 1709)
city: Petah Tikva
country: Israel
facility: Rabin Medical Center ( Site 1717)
city: Sakhnin
country: Israel
facility: Clalit Health Services - Sakhnin Community Clinic-Research Unit ( Site 1700)
city: Nijmegen
country: Netherlands
facility: Radboudumc-internal medicine ( Site 1952)
state: Gelderland
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, locatie AMC-Vascular Medicine Clin Trial Unit ( Site 1954)
state: Noord-Holland
city: Hoorn
country: Netherlands
facility: Vasculair Onderzoek Centrum Hoorn ( Site 1953)
state: Noord-Holland
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht-Vascular Medicine Research ( Site 1955)
city: Rotorua
country: New Zealand
facility: Pacific Clinical Research Network - Rotorua ( Site 2902)
state: Bay Of Plenty
city: Christchurch
country: New Zealand
facility: New Zealand Clinical Research (Christchurch) ( Site 2901)
state: Canterbury
city: Bodø
country: Norway
facility: Nordlandssykehuset ( Site 2001)
state: Nordland
city: Oslo
country: Norway
facility: Oslo Universitetssykehus Aker-Lipidklinikken ( Site 2000)
city: Singapore
country: Singapore
facility: National University Hospital-Department of Medicine ( Site 3212)
state: Central Singapore
city: Singapore
country: Singapore
facility: Changi General Hospital ( Site 3211)
state: Central Singapore
city: Sant Joan Despí
country: Spain
facility: Hospital de Sant Joan Despí Moisès Broggi ( Site 2335)
state: Cataluna
city: Reus
country: Spain
facility: SALUT SANT JOAN DE REUS-BAIX CAMP (EDP)-Vascular and Metabolism Unit ( Site 2329)
state: Tarragona
city: Valencia
country: Spain
facility: HOSPITAL CLINICO DE VALENCIA ( Site 2321)
state: Valenciana, Comunitat
city: New Taipei City
country: Taiwan
facility: Mackay Memorial Hospital -Tamshui Branch ( Site 3109)
state: New Taipei
city: Taipei City
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital ( Site 3106)
state: Taipei
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)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: