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)

Part of paid clinical trials in Lincoln, California.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT06450366
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Enlicitide — DRUG
    Oral tablet
  • Ezetimibe — DRUG
    Oral tablet
  • Bempedoic Acid — DRUG
    Oral capsule
  • Placebo for Enlicitide — OTHER
    enlicitide-matching placebo oral tablet
  • Placebo for Ezetimibe — OTHER
    ezetimibe-matching placebo oral tablet
  • Placebo for Bempedoic Acid — OTHER
    bempedoic acid-matching placebo oral capsule

Study Details

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.

Key Dates

Start date
Jul 8, 2024
Status verified
Mar 2026
Primary completion
Feb 14, 2025
Completion
Mar 28, 2025

Study Design

Enrollment
301 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Enlicitide
    Participants receive enlicitide 20mg, ezetimibe-matching placebo, and bempedoic acid-matching placebo once daily (QD) orally up to approximately 56 days.
  • Active Comparator: Ezetimibe
    Participants receive ezetimibe 10mg, enlicitide-matching placebo, and bempedoic acid-matching placebo QD orally up to approximately 56 days.
  • Active Comparator: Bempedoic Acid
    Participants receive bempedoic acid 180mg, ezetimibe-matching placebo, and enlicitide-matching placebo QD orally up to approximately 56 days.
  • Active Comparator: Ezetimibe + Bempedoic Acid
    Participants receive ezetimibe 10 mg, bempedoic acid 180mg, enlicitide-matching placebo orally QD for approximately 56 days.

Primary Outcome Measure

Mean Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Day 56 [ Time Frame: Baseline and Day 56 ]

Locations (7)

FacilityCityStateZIPSite coordinators
Clinical Trials Research ( Site 1509)LincolnCalifornia95648-
Healthcare Research Network - Chicago ( Site 1507)FlossmoorIllinois60422-
L-MARC Research Center ( Site 1501)LouisvilleKentucky40213-
Velocity Clinical Research Rockville ( Site 1503)RockvilleMaryland20854-
Velocity Clinical Research, Gulfport ( Site 1505)GulfportMississippi39503-
Piedmont Research Partners ( Site 1506)Fort MillSouth Carolina29707-
Rainier Clinical Research Center ( Site 1502)RentonWashington98057-

Find similar trials in Lincoln, CA

By research site
Clinical Trials Research· Lincoln, CAHealthcare Research Network - Chicago· Flossmoor, ILL-MARC Research Center· Louisville, KYVelocity Clinical Research Rockville· Rockville, MDVelocity Clinical Research, Gulfport· Gulfport, MSPiedmont Research Partners· Fort Mill, SC

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