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

Description

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

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Study Overview

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Study Details

Study overview

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).

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

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

Condition
Hypercholesterolemia
Intervention / Treatment

-

Contacts and Locations

Daphne

Alliance for Multispecialty Research, LLC ( Site 0027), Daphne, Alabama, United States, 36526

Foley

G&L Research ( Site 0035), Foley, Alabama, United States, 36535

Phoenix

Synexus Clinical Research US, Inc.-Synexus Clinical Research US, Inc - Central Phoenix ( Site 0048), Phoenix, Arizona, United States, 85020

Beverly Hills

National Heart Institute-Research ( Site 0029), Beverly Hills, California, United States, 90211

Sacramento

Clinical Trials Research ( Site 0054), Sacramento, California, United States, 95821

San Bernardino

Velocity Clinical Research, Banning ( Site 0023), San Bernardino, California, United States, 92408

Washington

Emerson Clinical Research Institute ( Site 0017), Washington, District of Columbia, United States, 20009

Boca Raton

Excel Medical Clinical Trials ( Site 0010), Boca Raton, Florida, United States, 33434

Coral Gables

Alliance for Multispecialty Research, LLC ( Site 0037), Coral Gables, Florida, United States, 33134

Fort Myers

Alliance for Multispecialty Research, LLC ( Site 0056), Fort Myers, Florida, United States, 33912

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Merck Sharp & Dohme LLC,

Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

2028-10-13