A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of MK-0616 Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia

CompletadoFase 3ClinicalTrials.gov

ID: NCT06450366Tipo: INTERVENTIONALInicio: 8 de jul de 2024Fin estimado: 28 de mar de 2025

Traducción no disponible, mostrando original

Resumen

The main purpose of this study is to assess whether enlicitide decanoate is superior to ezetimibe or bempedoic acid or ezetimibe + bempedoic acid in reducing LDL-C in participants with hypercholesterolemia, and to evaluate its safety and tolerability. The primary study hypotheses are enlicitide decanoate is superior to ezetimibe, bempedoic acid, and ezetimibe + bempedoic acid on mean percent change from baseline in LDL-C at week 8.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Has either a) history of a major atherosclerotic cardiovascular disease (ASCVD) event or b) if no history of a major ASCVD event, has intermediate to high risk for development of a first major ASCVD event
Has fasted lipid values (evaluated by the central laboratory) at Visit 1 (Screening) as follows: a) history of a major ASCVD event with LDL-C ≥55 mg/dL (≥1.42 mmol/L) OR b) No history of a major ASCVD event with LDL-C ≥70 mg/dL (≥1.81 mmol/L)
Is treated with a low, moderate, or high intensity statin (±non-statin lipid lowering therapy \[LLT\])
Is on a stable dose of all background LLTs with no planned medication or dose changes during the study
Is an individual of any sex/gender, from 18 years of age inclusive, at the time of providing the informed consent

Criterios de exclusión

Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria, compound heterozygous familial hypercholesterolemia (HeFH), or double HeFH
Has New York Heart Association class IV heart failure, or last known left ventricular ejection fraction ≤25% by any imaging method, or had a heart failure hospitalization within 3 months before Visit 1 (Screening)
Participants with a history of tendon disorder or tendon rupture
Participants with a history of gout
Is undergoing or previously underwent an LDL-C apheresis program within 3 months before Visit 1 (Screening) or plans to initiate an LDL-C apheresis program
Was previously treated/is being treated with certain other cholesterol lowering medications, including ezetimibe, bempedoic acid, or protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors without adequate washout

Intervenciones

drug

Enlicitide Decanoate

Administered orally.

drug

Ezetimibe

Administered orally.

drug

Bempedoic Acid

Administered orally.

other

Placebo for Enlicitide Decanoate

Administered orally.

other

Placebo for Ezetimibe

Administered orally.

other

Placebo for Bempedoic Acid

Administered orally.

Ubicaciones

Instituto de Investigaciones Clínicas Mar del Plata ( Site 1002)

Mar del Plata, Buenos Aires, Argentina

CIPREC-CIPREC Sede Arenales ( Site 1000)

Buenos Aires, Buenos Aires F.D., Argentina

Fundacion Estudios Clinicos ( Site 1001)

Rosario, Santa Fe Province, Argentina

Patrocinadores

PrincipalMerck Sharp & Dohme LLC

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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