Study

Overview

Official Title: A Phase 3, Open-label Extension Study to Evaluate the Safety and Efficacy of MK-0616 in Adults With Hypercholesterolemia

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).

Study Type:

Interventional

Study Phase:

Phase 3

Estimated Enrollment:

3000

Study Start Date:

August 2024

Estimated Study Completion Date:

October 2028

Estimated Primary Completion Date:

October 2028

Eligibility

Ages Eligible for Study:

18 years and older

Genders Eligible for Study:

All

Accepts Healthy Volunteers:

No

CRITERIA

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

Locations

No Contacts or Locations in US/Canada Provided

Results

No Study Results Posted

Study Detail

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

Overview

Eligibility

CRITERIA

Locations

Results