Clinical trial NCT06450366: A Study to Evaluate the Efficacy and Safety of Enlicitide Decanoate (MK-0616, Oral PCSK9 Inhibitor) Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia (MK-0616-018) CORALreef AddOn
Official title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of MK-0616 Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-06-10
Enrollment: 301
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 main purpose of this study is to assess whether enlicitide decanoate is superior to ezetimibe or bempedoic acid or ezetimibe + bempedoic acid in reducing LDL-C in participants with hypercholesterolemia, and to evaluate its safety and tolerability. The primary study hypotheses are enlicitide decanoate is superior to ezetimibe, bempedoic acid, and ezetimibe + bempedoic acid on mean percent change from baseline in LDL-C at week 8.


Eligibility criteria: Inclusion Criteria:

* Has either a) history of a major atherosclerotic cardiovascular disease (ASCVD) event or b) if no history of a major ASCVD event, has intermediate to high risk for development of a first major ASCVD event
* Has fasted lipid values (evaluated by the central laboratory) at Visit 1 (Screening) as follows: a) history of a major ASCVD event with LDL-C ≥55 mg/dL (≥1.42 mmol/L) OR b) No history of a major ASCVD event with LDL-C ≥70 mg/dL (≥1.81 mmol/L)
* Is treated with a low, moderate, or high intensity statin (±non-statin lipid lowering therapy \[LLT\])
* Is on a stable dose of all background LLTs with no planned medication or dose changes during the study
* Is an individual of any sex/gender, from 18 years of age inclusive, at the time of providing the informed consent

Exclusion Criteria:

* Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria, compound heterozygous familial hypercholesterolemia (HeFH), or double HeFH
* Has New York Heart Association class IV heart failure, or last known left ventricular ejection fraction ≤25% by any imaging method, or had a heart failure hospitalization within 3 months before Visit 1 (Screening)
* Participants with a history of tendon disorder or tendon rupture
* Participants with a history of gout
* Is undergoing or previously underwent an LDL-C apheresis program within 3 months before Visit 1 (Screening) or plans to initiate an LDL-C apheresis program
* Was previously treated/is being treated with certain other cholesterol lowering medications, including ezetimibe, bempedoic acid, or protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors without adequate washout

Primary outcomes:
measure: Mean Percent Change from Baseline in LDL-C at Day 56
timeFrame: Baseline and Day 56
Secondary outcomes:
measure: Mean Percent Change from Baseline in Apolipoprotein B (ApoB) at Day 56
timeFrame: Baseline and Day 56
measure: Mean Percent Change from Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Day 56
timeFrame: Baseline and Day 56
measure: Percent Change from Baseline in Lipoprotein(a) Levels (Lp[a])
timeFrame: Baseline and Day 56
measure: Percentage of Participants Who at Day 56 Have an LDL-C <70 mg/dL and ≥50% Reduction from Baseline
timeFrame: Baseline and Day 56
measure: Percentage of Participants Who at Day 56 Have an LDL-C <55 mg/dL and ≥50% Reduction from Baseline
timeFrame: Baseline and Day 56
measure: Number of Participants With ≥1 Adverse Event (AE)
timeFrame: Up to Approximately 112 days
measure: Number of Participants Discontinuing from Study Therapy Due to AE
timeFrame: Up to Approximately 56 days
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Clinical Trials Research ( Site 1509)
state: California
city: Flossmoor
country: United States
facility: Healthcare Research Network - Chicago ( Site 1507)
state: Illinois
city: Louisville
country: United States
facility: L-MARC Research Center ( Site 1501)
state: Kentucky
city: Rockville
country: United States
facility: Velocity Clinical Research Rockville ( Site 1503)
state: Maryland
city: Gulfport
country: United States
facility: Velocity Clinical Research, Gulfport ( Site 1505)
state: Mississippi
city: Fort Mill
country: United States
facility: Piedmont Research Partners ( Site 1506)
state: South Carolina
city: Renton
country: United States
facility: Rainier Clinical Research Center ( Site 1502)
state: Washington
city: Mar del Plata
country: Argentina
facility: Instituto de Investigaciones Clínicas Mar del Plata ( Site 1002)
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: CIPREC-CIPREC Sede Arenales ( Site 1000)
state: Caba
city: Rosario
country: Argentina
facility: Fundacion Estudios Clinicos ( Site 1001)
state: Santa Fe
city: Vancouver
country: Canada
facility: The Medical Arts Health Research Group ( Site 1606)
state: British Columbia
city: Cambridge
country: Canada
facility: Cambridge Cardiac Care Centre ( Site 1603)
state: Ontario
city: North York
country: Canada
facility: North York Diagnostic and Cardiac Centre ( Site 1605)
state: Ontario
city: Montreal
country: Canada
facility: Institut de Cardiologie de Montreal ( Site 1604)
state: Quebec
city: Trois-Rivieres
country: Canada
facility: Diex Recherche Trois-Rivieres ( Site 1602)
state: Quebec
city: Montpellier
country: France
facility: Hôpital Arnaud de Villeneuve - CHU Montpellier ( Site 0505)
state: Herault
city: Nantes Cedex 1
country: France
facility: Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes-CIC Endocrinology-Diabetology-Nutrition ( Sit
state: Loire-Atlantique
city: Bron
country: France
facility: Hospices Civils de Lyon - Hopital Louis Pradel ( Site 0501)
state: Rhone
city: Paris
country: France
facility: Hôpital Bichat - Claude-Bernard ( Site 0504)
city: Be Er Sheva
country: Israel
facility: Assuta Beersheba MC ( Site 0704)
city: Beer Yaakov
country: Israel
facility: Yitzhak Shamir Medical Center. ( Site 0702)
city: Haifa
country: Israel
facility: Rambam Health Care Campus ( Site 0700)
city: Kfar Saba
country: Israel
facility: Meir Medical Center. ( Site 0703)
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria-UGC Endocrinologia y nutricion ( Site 0801)
state: Andalucia
city: Figueres
country: Spain
facility: Hospital de Figueres ( Site 0804)
state: Gerona
city: A Coruna
country: Spain
facility: Hospital San Rafael de Coruna ( Site 0805)
state: La Coruna
city: Barcelona
country: Spain
facility: EAP Sardenya ( Site 0800)
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron ( Site 0803)
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital-Internal Medicine ( Site 0403)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 0400)
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital-Department of Medicine ( Site 0402)
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch ( Site 0404)
city: London
country: United Kingdom
facility: Barts Health NHS Trust-William Harvey Clinical Research Centre ( Site 0901)
state: England
city: London
country: United Kingdom
facility: Royal Free Hospital ( Site 0900)
state: England
city: London
country: United Kingdom
facility: National Institute for Health Research UCLH Clinical Research Facility ( Site 0908)
state: London, City Of
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: