Open-label Extension Study of Enlicitide Decanoate (MK-0616 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)

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 parent study [MK-0616-013 (NCT05952856), MK-0616-017 (NCT05952869), and MK-0616-018 (NCT Number pending)] 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 currently participating in an interventional clinical study other than an enlicitide decanoate parent study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3,000 participants in 1 patient group

Enlicitide Decanoate

Experimental group

Description:

Participants will receive 20 mg of enlicitide decanoate orally once daily (QD)

Treatment:

Drug: Enlicitide Decanoate