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

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT06492291Tipo: INTERVENTIONALInicio: 5 de ago de 2024Fin estimado: 13 de oct de 2028

Traducción no disponible, mostrando original

Resumen

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).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

Enlicitide Decanoate

Oral tablet

Ubicaciones

CEDIC ( Site 0603)

CABA, Buenos Aires, Argentina

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0605)

CABA, Buenos Aires, Argentina

Instituto de Investigaciones Clínicas Mar del Plata ( Site 0602)

Mar del Plata, Buenos Aires, Argentina

Instituto de Investigaciones Clinicas Zarate ( Site 0604)

Zárate, Buenos Aires, Argentina

Fundacion Estudios Clinicos ( Site 0601)

Rosario, Santa Fe Province, Argentina

Centro de Investigaciones Metabolicas CINME - Cardiology ( Site 0607)

CABA, Argentina

CIPREC ( Site 0600)

CABA, Argentina

Fundación Respirar ( Site 0606)

CABA, Argentina

Patrocinadores

PrincipalMerck Sharp & Dohme LLC

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