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

Merck Sharp & Dohme (MSD)

Status and phase

Enrolling

Phase 3

Conditions

Hypercholesterolemia

Treatments

Drug: Enlicitide Decanoate

Study type

Interventional

Funder types

Industry

Identifiers

NCT06492291

0616-019

U1111-1290-3950 (Other Identifier)

MK-0616-019 (Other Identifier)

jRCT2051240110 (Registry Identifier)

2023-504922-20 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment

3,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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