Status:
ACTIVE_NOT_RECRUITING
Open-label Extension Study of Enlicitide Decanoate (MK-0616/Enlicitide Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-019) CORALreef Extension
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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-06...
Eligibility Criteria
Inclusion
- Has completed an enlicitide decanoate (also known as enlictide and MK-0616) parent study \[MK-0616-013 (NCT05952856), MK-0616-017 (NCT05952869), and MK-0616-018 (NCT06450366)\] per protocol (including the final assessments/procedures of their parent study)
- Had an overall study intervention compliance ≥80% while participating in their parent study
Exclusion
- Has discontinued study intervention in their parent study
- Has an ongoing serious adverse event considered related to study intervention by the investigator in the parent study
- Is planning to begin treatment with a nonstudy protein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) while enrolled in the study
- Is currently participating in an interventional clinical study other than an enlicitide decanoate parent study
Key Trial Info
Start Date :
August 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 13 2028
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT06492291
Start Date
August 5 2024
End Date
October 13 2028
Last Update
October 7 2025
Active Locations (222)
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1
Alliance for Multispecialty Research, LLC ( Site 0027)
Daphne, Alabama, United States, 36526
2
G&L Research ( Site 0035)
Foley, Alabama, United States, 36535
3
Synexus Clinical Research US, Inc.-Synexus Clinical Research US, Inc - Central Phoenix ( Site 0048)
Phoenix, Arizona, United States, 85020
4
National Heart Institute-Research ( Site 0029)
Beverly Hills, California, United States, 90211