Study to Evaluate the Efficacy and Safety of Combination ... | EligiMed

Study to Evaluate the Efficacy and Safety of Combination Therapy of K-877-ER and CSG452 in Participants With Noncirrhotic Nonalcoholic Steatohepatitis (NASH) With Liver Fibrosis

Activo, no reclutaFase 2ClinicalTrials.gov

ID: NCT05327127Tipo: INTERVENTIONALInicio: 14 de nov de 2022Fin estimado: 1 de mar de 2026

Neumología Gastroenterología Enfermedades Infecciosas

Traducción no disponible, mostrando original

Resumen

A study to investigate the use of combination therapy with two investigational products for the treatment of adult patients with Nonalcoholic steatohepatitis (NASH).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Able to understand and comply with study procedures and give written informed consent
Age ≥18 years
NAS ≥4 with a score of at least 1 in each component of the NAS (steatosis, lobular inflammation, and ballooning) at Visit 2 liver biopsy, or a historical liver biopsy performed within 24 weeks of randomization
Fibrosis stage of 1 or greater and below 4 on NASH CRN (Clinical Research Network) fibrosis staging system at Visit 2 liver biopsy, or a historical liver biopsy performed within 24 weeks of randomization

Criterios de exclusión

Participation in another clinical trial involving an investigational agent within 30 days prior to signing the Informed Consent Form (ICF) for this study
Ongoing or recent consumption of Greater than moderate amounts of alcohol as defined in clinical study protocol
Evidence of other forms of chronic liver disease as defined in clinical study protocol

Intervenciones

drug

K-877-ER

K-877-ER tablet

drug

CSG452

CSG452 tablet

drug

Placebo

Placebo tablet

Ubicaciones

Hospital Italiano de Buenos Aires

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

CINME - Centro De Investigaciones Metabolicas

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Hospital Italiano de La Plata

La Plata, Buenos Aires, Argentina

Instituto de Investigaciones Clinicas de Mar del Plata

Mar del Plata, Buenos Aires, Argentina

Hospital Universitario Austra

Pilar, Buenos Aires, Argentina

Hospital Provincial del Centenario

Santa Fe, Rosario, Argentina

Patrocinadores

PrincipalKowa Research Institute, Inc.

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