Open-label Extension Study of Enlicitide Decanoate (MK-0616/Enlicitide Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-019) CORALreef Extension
HypercholesterolemiaThis 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).
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
18 and up
Participation Criteria
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
Study Location
Institut de Cardiologie de Montreal ( Site 0504)
Institut de Cardiologie de Montreal ( Site 0504)Montreal, Quebec
Canada
Contact Study Team
Study Coordinator
514-376-3330Ecogene-21 ( Site 0500)
Ecogene-21 ( Site 0500)Chicoutimi, Quebec
Canada
Contact Study Team
Study Coordinator
4185451252The Medical Arts Health Research Group ( Site 0506)
The Medical Arts Health Research Group ( Site 0506)North Vancouver, British Columbia
Canada
Contact Study Team
Study Coordinator
250-382-4038Diex Recherche Trois-Rivieres ( Site 0503)
Diex Recherche Trois-Rivieres ( Site 0503)Trois-Rivieres, Quebec
Canada
Contact Study Team
Study Coordinator
819-801-9797North York Diagnostic and Cardiac Centre ( Site 0505)
North York Diagnostic and Cardiac Centre ( Site 0505)North York, Ontario
Canada
Contact Study Team
Study Coordinator
4167830000Cambridge Cardiac Care Centre ( Site 0502)
Cambridge Cardiac Care Centre ( Site 0502)Cambridge, Ontario
Canada
Contact Study Team
Study Coordinator
1-888-577-8839- Study Sponsored By
- Merck Sharp & Dohme LLC
- Participants Required
- More Information
- Study ID:
NCT06492291