Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06450366 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Hypercholesterolemia, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 301
- Enrollment target
- 20
- Study locations
NCT06450366 is a Phase 3 study of Hypercholesterolemia that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 301 participants, below the 812-participant average among 62 other Hypercholesterolemia trials with a reported enrollment target (63% lower). The trial reports 20 study locations across 17 states.
The verdict
NCT06450366, a Phase 3 study of Hypercholesterolemia, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 301 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 301 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 812-participant average among 62 other Hypercholesterolemia trials with a reported enrollment target (63% lower). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
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.
NCT06450366 reports 20 study locations spanning 17 distinct geographic areas - top geographies include Ontario, Quebec, Other.
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.
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).
Who is sponsoring clinical trial NCT06450366?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Hypercholesterolemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Open-label Extension Study of Enlicitide Decanoate (MK-0616/Enlicitide Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-019) CORALreef Extension
ACTIVE NOT RECRUITING · Phase 3
-
Effect of a Decision Aid About Statin Use in Patients With Type 2 Diabetes Mellitus
COMPLETED · Phase 3
-
Evaluation of Evolocumab (AMG 145) Efficacy in Diabetic Adults With Hypercholesterolemia/Mixed Dyslipidemia
COMPLETED · Phase 3
-
Actual Use Trial of Atorvastatin Calcium 10 mg
COMPLETED · Phase 3
-
Action to Control Cardiovascular Risk in Diabetes (ACCORD)
COMPLETED · Phase 3
-
GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound
COMPLETED · Phase 3
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.