A Study to Evaluate the Efficacy and Safety of Enlicitide (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)

Merck Sharp & Dohme LLC301 enrolled

Overview

The main purpose of this study is to assess whether enlicitide is superior to ezetimibe or bempedoic acid or ezetimibe + bempedoic acid in reducing low-density lipoprotein cholesterol (LDL-C) in participants with hypercholesterolemia, and to evaluate its safety and tolerability. The primary study hypotheses are enlicitide is superior to ezetimibe, bempedoic acid, and ezetimibe + bempedoic acid on mean percent change from baseline in LDL-C at week 8.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

301

Conditions

Hypercholesterolemia

Interventions

EnlicitideDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 low-density lipoprotein cholesterol (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

Locations (35)

Clinical Trials Research ( Site 1509)

Lincoln, California, United States

Healthcare Research Network - Chicago ( Site 1507)

Flossmoor, Illinois, United States

L-MARC Research Center ( Site 1501)

Louisville, Kentucky, United States

Velocity Clinical Research Rockville ( Site 1503)

Rockville, Maryland, United States

Velocity Clinical Research, Gulfport ( Site 1505)

Gulfport, Mississippi, United States

Outcomes

Primary Outcomes

Mean Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Day 56

Blood samples were collected at baseline and after 56 days of treatment to assess mean percentage change in LDL-C. The mean percent change from baseline in LDL-C at Day-56 is reported.