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

Running, not enrolling · Phase 3

Conditions studied: Hypercholesterolemia

In brief

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).

Key facts

Study ID

NCT06492291

Run by

Merck Sharp & Dohme LLC

People needed

3000

Starts

2024-08-05

Expected to finish

2028-10-13

Last updated by the study team

2025-10-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• G&L Research ( Site 0035) — Foley, Alabama, United States
• Synexus Clinical Research US, Inc.-Synexus Clinical Research US, Inc - Central Phoenix ( Site 0048) — Phoenix, Arizona, United States
• National Heart Institute-Research ( Site 0029) — Beverly Hills, California, United States
• Clinical Trials Research ( Site 0054) — Sacramento, California, United States
• Velocity Clinical Research, Banning ( Site 0023) — San Bernardino, California, United States
• Emerson Clinical Research Institute ( Site 0017) — Washington D.C., District of Columbia, United States
• Excel Medical Clinical Trials ( Site 0010) — Boca Raton, Florida, United States
• Alliance for Multispecialty Research, LLC ( Site 0037) — Doral, Florida, United States
• Alliance for Multispecialty Research, LLC ( Site 0056) — Fort Myers, Florida, United States
• Velocity Clinical Research, Hallandale Beach ( Site 0053) — Hallandale, Florida, United States
• Jacksonville Center for Clinical Research ( Site 0025) — Jacksonville, Florida, United States
• South Broward Research ( Site 0012) — Miramar, Florida, United States
• Progressive Medical Research ( Site 0033) — Port Orange, Florida, United States
• Clinical Research Trials of Florida ( Site 0006) — Tampa, Florida, United States
• Clinical Site Partners, LLC dba Flourish Research ( Site 0004) — Winter Park, Florida, United States
• East Coast Institute for Research, LLC ( Site 0020) — Macon, Georgia, United States
• Healthcare Research Network - Chicago ( Site 0051) — Flossmoor, Illinois, United States
• Synexus Clinical Research US - Evansville ( Site 0005) — Evansville, Indiana, United States
• Midwest Institute For Clinical Research ( Site 0052) — Indianapolis, Indiana, United States
• Alliance for Multispecialty Research, LLC ( Site 0001) — Lexington, Kentucky, United States
• L-MARC Research Center ( Site 0011) — Louisville, Kentucky, United States
• Velocity Clinical Research, Covington ( Site 0026) — Covington, Louisiana, United States
• Velocity Clinical Research Rockville ( Site 0022) — Rockville, Maryland, United States
• Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0018) — Troy, Michigan, United States
• Alliance for Multispecialty Research, LLC ( Site 0027) — Daphne, Alabama, United States

Full record on ClinicalTrials.gov

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