NCT06492291

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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,000 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	Enlicitide Decanoate	Oral tablet

Timeline

• Start date: 2024-08-05
• Primary completion: 2028-10-13
• Completion: 2028-10-13
• First posted: 2024-07-09
• Last updated: 2025-10-07

Locations

222 sites across 28 countries: United States, Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Czechia, Finland, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Singapore, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study