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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
NCT06450366 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Bempedoic Acid
- DRUG Ezetimibe
- DRUG Enlicitide Decanoate
- OTHER Placebo for Enlicitide Decanoate
- OTHER Placebo for Ezetimibe
Study Locations (20)
Ontario
- Cambridge Cardiac Care Centre ( Site 1603) — Cambridge
- North York Diagnostic and Cardiac Centre ( Site 1605) — North York
Quebec
- Institut de Cardiologie de Montreal ( Site 1604) — Montreal
- Diex Recherche Trois-Rivieres ( Site 1602) — Trois-Rivières
Other
- Hôpital Bichat - Claude-Bernard ( Site 0504) — Paris
- Yitzhak Shamir Medical Center. ( Site 0702) — Beer Yaakov
California
- Clinical Trials Research ( Site 1509) — Lincoln
Illinois
- Healthcare Research Network - Chicago ( Site 1507) — Flossmoor
Kentucky
- L-MARC Research Center ( Site 1501) — Louisville
Maryland
- Velocity Clinical Research Rockville ( Site 1503) — Rockville
Mississippi
- Velocity Clinical Research, Gulfport ( Site 1505) — Gulfport
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 301 participants |
| Start Date | 2024-07-08 |
| Est. Completion | 2025-03-28 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06450366
The ClinicalTrials.gov registry entry for NCT06450366 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 301 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Hypercholesterolemia appearing as the primary indexed condition, and to 5 interventions — of which Bempedoic Acid is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06450366 reports 20 study locations spanning 17 distinct geographic areas — top geographies include Ontario, Quebec, Other. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06450366 about?
NCT06450366 is a clinical study titled "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". 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 deca...
What is the current status of trial NCT06450366?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 301 participants. The study started on 2024-07-08. Estimated completion is 2025-03-28.
What conditions does trial NCT06450366 study?
This clinical trial studies the following conditions: Hypercholesterolemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06450366?
The interventions under investigation include: Bempedoic Acid (DRUG), Ezetimibe (DRUG), Enlicitide Decanoate (DRUG), Placebo for Enlicitide Decanoate (OTHER), Placebo for Ezetimibe (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06450366?
This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06450366 being conducted?
This trial has 20 study locations across California, Illinois, Kentucky, Maryland, Mississippi. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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