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

NCT06492291 · tracked via the Priya Life Science UK tracker

Sponsor

Merck Sharp & Dohme LLC

Phase

Phase 3

Started

2024-08-05

Last updated

2025-10-07

Condition(s) studied

Hypercholesterolemia

Investigational drug(s) / intervention(s)

Enlicitide Decanoate

Enlicitide Decanoate: Oral tablet

Study 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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

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

Primary outcome measure(s)

Number of participants with one or more adverse events (AEs) — Up to approximately 3 years
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Number of participants who discontinue study drug due to an AE — Up to approximately 3 years
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Trial sites (222)

Facility	City	Region
Alliance for Multispecialty Research, LLC ( Site 0027)	Daphne	Alabama
G&L Research ( Site 0035)	Foley	Alabama
Synexus Clinical Research US, Inc.-Synexus Clinical Research US, Inc - Central Phoenix ( Site 0048)	Phoenix	Arizona
National Heart Institute-Research ( Site 0029)	Beverly Hills	California
Clinical Trials Research ( Site 0054)	Sacramento	California
Velocity Clinical Research, Banning ( Site 0023)	San Bernardino	California
Emerson Clinical Research Institute ( Site 0017)	Washington D.C.	District of Columbia
Excel Medical Clinical Trials ( Site 0010)	Boca Raton	Florida
Alliance for Multispecialty Research, LLC ( Site 0037)	Doral	Florida
Alliance for Multispecialty Research, LLC ( Site 0056)	Fort Myers	Florida
Velocity Clinical Research, Hallandale Beach ( Site 0053)	Hallandale	Florida
Jacksonville Center for Clinical Research ( Site 0025)	Jacksonville	Florida
South Broward Research ( Site 0012)	Miramar	Florida
Progressive Medical Research ( Site 0033)	Port Orange	Florida
Clinical Research Trials of Florida ( Site 0006)	Tampa	Florida
Clinical Site Partners, LLC dba Flourish Research ( Site 0004)	Winter Park	Florida
East Coast Institute for Research, LLC ( Site 0020)	Macon	Georgia
Healthcare Research Network - Chicago ( Site 0051)	Flossmoor	Illinois
Synexus Clinical Research US - Evansville ( Site 0005)	Evansville	Indiana
Midwest Institute For Clinical Research ( Site 0052)	Indianapolis	Indiana
Alliance for Multispecialty Research, LLC ( Site 0001)	Lexington	Kentucky
L-MARC Research Center ( Site 0011)	Louisville	Kentucky
Velocity Clinical Research, Covington ( Site 0026)	Covington	Louisiana
Velocity Clinical Research Rockville ( Site 0022)	Rockville	Maryland
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0018)	Troy	Michigan
Velocity Clinical Research, Gulfport ( Site 0032)	Gulfport	Mississippi
Healthcare Research Network - St. Louis ( Site 0040)	Hazelwood	Missouri
Velocity Clinical Research at The Pioneer Heart Institute, Lincoln ( Site 0031)	Lincoln	Nebraska
Jubilee Clinical Research ( Site 0049)	Las Vegas	Nevada
AB Clinical Trials ( Site 0002)	Las Vegas	Nevada
New Mexico Clinical Research & Osteoporosis Center ( Site 0043)	Albuquerque	New Mexico
Velocity Clinical Research, Syracuse ( Site 0014)	East Syracuse	New York
Icahn School of Medicine at Mount Sinai-Cardiology ( Site 0042)	New York	New York
Lillestol Research ( Site 0030)	Fargo	North Dakota
altoona center for clinical research ( Site 0024)	Duncansville	Pennsylvania
Cardiology Consultants of Philadelphia Yardley ( Site 0021)	Yardley	Pennsylvania
Velocity Clinical Research, Anderson ( Site 0015)	Anderson	South Carolina
Piedmont Research Partners ( Site 0045)	Fort Mill	South Carolina
Coastal Carolina Research Center ( Site 0055)	North Charleston	South Carolina
Monument Health Clinical Research, a department of Monument -Monument Health Clinical Research, a d ( Site 0038)	Rapid City	South Dakota

+ 182 more sites — see the full list on the official registry below.

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Extension Study of Sotatercept in People With Pulmonary Hypertension (MK-7962-023) Active, not recruiting

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Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689) Active, not recruiting

A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009) Recruiting

Other trials for the same condition

Treatment With Bempedoic Acid and/or Its Fixed-dose Combination With Ezetimibe in Primary Hypercholesterolemia or Mixed Dyslipidemia Active, not recruiting

Long-term Follow-up of Participants Dosed With an Investigational Gene Editing Therapy for Cardiovascular Disease Enrolling by invitation

Phase 1b Study of VERVE-201 in Patients With Refractory Hyperlipidemia Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06492291 on ClinicalTrials.gov ↗ ← All trials in the UK