Last updated 10 days ago
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
300 patients around the world
Available in Spain, Argentina, United States
Merck Sharp & Dohme LLC
2Research sites
300Patients around the world
This study is for people with
Hypercholesterolemia
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Has either a history of a major atherosclerotic cardiovascular disease (ASCVD) event or 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 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.
- 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.
Sites
CIPREC Centro de Investigación y Prevención Cardiovascular - CABA
Recruiting
Instituto Médico de la Fundación Estudios Clínicos - Rosario
Recruiting
SponsorMerck Sharp & Dohme LLC
Conditions
Hypercholesterolemia
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06450366
