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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: Completed Phase 3 study of Hypercholesterolemia, sponsored by Merck Sharp & Dohme.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
What the finished NCT06450366 record still lists
NCT06450366 is an interventional study that assigns participants to a tested intervention. The registered 301 participants enrollment target is mid-sized for trials with a published cap, below the 812-participant average among 62 other Hypercholesterolemia trials with a reported enrollment target (63% lower).
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 names 20 study sites across 17 states, led by 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
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Where NCT06450366's enrollment target sits among peer trials
301 27th of 62 higher than 36 of 62 other Hypercholesterolemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypercholesterolemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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