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NCT06492291 · ClinicalTrials.gov registry record · Phase 3
Open-label Extension Study of Enlicitide Decanoate (MK-0616/Enlicitide Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-019) CORALreef Extension
A Phase 3 study of Hypercholesterolemia, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 3
- Development phase
- 3,000
- Enrollment target
- 20
- Study locations
NCT06492291: Active Phase 3 study of Hypercholesterolemia, sponsored by Merck Sharp & Dohme.
NCT06492291 is a Phase 3 study of Hypercholesterolemia that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 3,000 participants, above the 768-participant average among 62 other Hypercholesterolemia trials with a reported enrollment target (291% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06492291, a Phase 3 study of Hypercholesterolemia, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 3,000 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is an extension study to evaluate the longer-term safety and efficacy of enlicitide decanoate in adults with hypercholesterolemia who completed either study MK-0616-013 (NCT05952856), study MK-0616-017 (NCT05952869), or study MK-0616-018 (NCT06450366).
Primary Outcome
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Conditions Studied
Interventions
- DRUG Enlicitide Decanoate
Study Locations (20)
Florida
- Excel Medical Clinical Trials ( Site 0010) - Boca Raton
- Alliance for Multispecialty Research, LLC ( Site 0037) - Doral
- Alliance for Multispecialty Research, LLC ( Site 0056) - Fort Myers
- Velocity Clinical Research, Hallandale Beach ( Site 0053) - Hallandale
- Jacksonville Center for Clinical Research ( Site 0025) - Jacksonville
- South Broward Research ( Site 0012) - Miramar
- Progressive Medical Research ( Site 0033) - Port Orange
- Clinical Research Trials of Florida ( Site 0006) - Tampa
- Clinical Site Partners, LLC dba Flourish Research ( Site 0004) - Winter Park
California
- National Heart Institute-Research ( Site 0029) - Beverly Hills
- Clinical Trials Research ( Site 0054) - Sacramento
- Velocity Clinical Research, Banning ( Site 0023) - San Bernardino
Alabama
- Alliance for Multispecialty Research, LLC ( Site 0027) - Daphne
- G&L Research ( Site 0035) - Foley
Indiana
- Synexus Clinical Research US - Evansville ( Site 0005) - Evansville
- Midwest Institute For Clinical Research ( Site 0052) - Indianapolis
Arizona
- Synexus Clinical Research US, Inc.-Synexus Clinical Research US, Inc - Central Phoenix ( Site 0048) - Phoenix
District of Columbia
- Emerson Clinical Research Institute ( Site 0017) - Washington D.C.
Georgia
- East Coast Institute for Research, LLC ( Site 0020) - Macon
Illinois
- Healthcare Research Network - Chicago ( Site 0051) - Flossmoor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,000 participants |
| Start Date | 2024-08-05 |
| Est. Completion | 2028-10-13 |
| Phase | Phase 3 |
What the registry record for NCT06492291 still lists
NCT06492291 is an interventional study that assigns participants to a tested intervention. Its 3,000 participants enrollment target places it among the larger protocols in the corpus, above the 768-participant average among 62 other Hypercholesterolemia trials with a reported enrollment target (291% higher).
The record links to 1 condition, with Hypercholesterolemia appearing as the primary indexed condition, and to 1 intervention - of which Enlicitide Decanoate is the first listed.
NCT06492291 names 20 study sites across 8 states, led by Florida, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT06492291 about?
NCT06492291 is a clinical study titled "Open-label Extension Study of Enlicitide Decanoate (MK-0616/Enlicitide Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-019) CORALreef Extension". This is an extension study to evaluate the longer-term safety and efficacy of enlicitide decanoate in adults with hypercholesterolemia who completed either study MK-0616-013 (NCT05952856), study MK-0616-017 (NCT05952869), or study MK-0616-018 (NCT06450366).
What is the current status of trial NCT06492291?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 3,000 participants. The study started on 2024-08-05. Estimated completion is 2028-10-13.
What conditions does trial NCT06492291 study?
This clinical trial studies the following conditions: Hypercholesterolemia.
What interventions are being tested in trial NCT06492291?
The interventions under investigation include: Enlicitide Decanoate (DRUG).
Who is sponsoring clinical trial NCT06492291?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06492291 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, District of Columbia, Florida. 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.
Where NCT06492291's enrollment target sits among peer trials
3,000 3rd of 62 higher than 60 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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