Open-label Extension Study of Enlicitide Decanoate (MK-0616/Enlicitide Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-019) CORALreef Extension

ID#: NCT06492291

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Recruiting

Start Date: August 05, 2024

End Date: October 13, 2028

Contact Information:
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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).
Eligibility:

Inclusion Criteria:

- 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 Criteria:

- 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
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