๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-10-03

Open-label Extension Study of Enlicitide Decanoate (MK-0616/Enlicitide Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-019) CORALreef Extension (NCT06492291)

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

๐Ÿ”ต Active, Not Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Merck Sharp & Dohme LLC

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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).

Who can join: Review the eligibility criteria below.

Location: Alliance for Multispecialty Research, LLC ( Site 0027) โ€” Daphne, Alabama

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (222 Sites)

Showing the first 25 of 222 sites.

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

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—