A Phase 2b Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-3655 in Individuals With Pre-cirrhotic Nonalcoholic Steatohepatitis.

TerminadoFase 2ClinicalTrials.gov

ID: NCT04583423Tipo: INTERVENTIONALInicio: 11 de nov de 2020Fin estimado: 13 de abr de 2023

Neurología Gastroenterología Enfermedades Infecciosas

Traducción no disponible, mostrando original

Resumen

This study will evaluate the effect of each dose of MK-3655 versus placebo on the percentage of individuals with NASH resolution without worsening of fibrosis after 52 weeks. The primary hypothesis of the study is that at least 1 dose of MK-3655 is superior to placebo with respect to the percentage of individuals with NASH resolution without worsening of fibrosis after 52 weeks.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

Has histological confirmation of NASH
Is a male or female aged 18 years to 80 years (in Japan and Taiwan aged 20 to 80 years)
Has a body mass index (BMI) ≥25 kg/m\^2 and ≤50 kg/m\^2 and stable weight for the past 3 months
Has no history of Type 2 diabetes mellitus (T2DM) OR a history of T2DM controlled by diet or stable doses of antihyperglycemic agents (AHAs)
Contraceptive use by male participants should be consistent with local regulations.
A female participant is eligible to participate if she is not pregnant or breastfeeding, and she is not a woman of child-bearing potential (WOCBP) OR she is a WOCBP and uses a contraceptive method that is highly effective during the intervention period and for at least 16 weeks after the last dose of study intervention.

Criterios de exclusión

Has presence of cirrhosis on liver biopsy
Has Type 1 diabetes
Has a history of malignancy, unless cancer free ≥5 years, or is under evaluation for active or suspected malignancy except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
Has a history of bariatric surgery ≤5 years before study participation
Has undergone a major surgical procedure ≤3 months before study participation or has major surgery planned during the study
Has a history or evidence of chronic liver disease other than NASH. Individuals with a history of Hepatitis B or C may be eligible for participation.
Has significant systemic or major illnesses other than liver disease, including recent events (≤6 months before study entry) of congestive heart failure, unstable coronary artery disease, arterial revascularization, pulmonary disease, renal failure, stroke, transient ischemic attack, or organ transplantation

Intervenciones

drug

MK-3655

MK-3655 50, 100 or 300 dose for injection

drug

Placebo

Matching placebo to MK-3655

Ubicaciones

Instituto de Investigaciones Clínicas Mar del Plata ( Site 0010)

Mar del Plata, Buenos Aires, Argentina

Hospital Universitario Austral ( Site 0003)

Pilar, Buenos Aires, Argentina

DIM Clínica Privada ( Site 0011)

Ramos Mejía, Buenos Aires, Argentina

Hospital Británico de Buenos Aires ( Site 0002)

Buenos Aires, Buenos Aires F.D., Argentina

Glenny Corp. S.A.-CLINICAL RESEARCH ( Site 0013)

Buenos Aires, Buenos Aires F.D., Argentina

Hospital Italiano de Buenos Aires-Hepatology ( Site 0014)

Ciudad de Buenos Aires, Buenos Aires F.D., Argentina

Hospital Provincial del Centenario ( Site 0007)

Rosario, Santa Fe Province, Argentina

Hospital Aleman ( Site 0009)

Buenos Aires, Argentina

Clinica de nefrologia urologia y enfermedades cardiovasculares ( Site 0008)

Santa Fe, Argentina

Patrocinadores

PrincipalMerck Sharp & Dohme LLC

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