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)

ClinicalTrials.gov ID: NCT06450366

Public ClinicalTrials.gov record NCT06450366. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 1, 2026, 2:13 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID: NCT06450366
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Merck Sharp & Dohme LLC; Industry
Enrollment: 301 participants

Conditions and interventions

Conditions

Hypercholesterolemia

Interventions

Drug · Other

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jul 7, 2024
Primary completion: Feb 13, 2025
Completion: Mar 27, 2025
Last update posted: Mar 26, 2026

2024 – 2025

United States locations

U.S. sites: 7
U.S. states: 7
U.S. cities: 7

Facility	City	State	ZIP	Site status
Clinical Trials Research ( Site 1509)	Lincoln	California	95648	—
Healthcare Research Network - Chicago ( Site 1507)	Flossmoor	Illinois	60422	—
L-MARC Research Center ( Site 1501)	Louisville	Kentucky	40213	—
Velocity Clinical Research Rockville ( Site 1503)	Rockville	Maryland	20854	—
Velocity Clinical Research, Gulfport ( Site 1505)	Gulfport	Mississippi	39503	—
Piedmont Research Partners ( Site 1506)	Fort Mill	South Carolina	29707	—
Rainier Clinical Research Center ( Site 1502)	Renton	Washington	98057	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 28 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06450366, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Mar 26, 2026 · Synced Sep 1, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06450366 live on ClinicalTrials.gov.

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