Resumen

Semaglutida es un medicamento estudiado en pacientes con EHNA. Es un medicamento bien conocido que los médicos ya utilizan para tratar la diabetes tipo 2 en muchos países. Los participantes recibirán semaglutida o un medicamento placebo; el tratamiento que recibe cada participante se decide al azar. Los participantes deberán autoadministrarse el medicamento mediante inyección subcutánea, una vez por semana. El estudio tendrá una duración de aproximadamente 5 años. Los participantes tendrán hasta 21 visitas clínicas y 9 llamadas telefónicas con el personal clínico durante el estudio. Algunas de las visitas clínicas podrán realizarse en más de un día. Los participantes con otras enfermedades hepáticas crónicas no pueden participar en este estudio. Las mujeres no pueden participar si están embarazadas, en período de lactancia o planean quedarse embarazadas durante el período del estudio.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Age above or equal to 18 years at the time of signing informed consent.
Histological evidence of NASH based on a central pathologist evaluation of the baseline liver biopsy. The baseline liver biopsy can be a historical biopsy obtained within 180 days prior to the screening visit (V1).
Histological evidence of fibrosis stage 2 or stage 3 according to the NASH CRN (Clinical Research Network) classification based on a central pathologist evaluation of the baseline liver biopsy.
A histological NAS (Non-alcoholic fatty liver disease Activity Score) above or equal to 4 with a score of 1 or more in steatosis, lobular inflammation and hepatocyte ballooning based on a central pathologist evaluation of the baseline liver biopsy.

Criterios de exclusión

Documented causes of chronic liver disease other than non-alcoholic fatty liver disease (NAFLD)
Positive HBsAg, positive anti-HIV, positive HCV RNA at screening (V2A) or any known presence of HCV RNA or HBsAg within 2 years of screening (V2A).
Presence or history of ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis or liver transplantation at randomisation.
Known or suspected excessive consumption of alcohol (greater than 20 g/day for women or greater than 30 g/day for men) or alcohol dependence (assessed by the Alcohol Use Disorders Identification Test (AUDIT questionnaire)).
Treatment with vitamin E (at doses greater than or equal to 800 IU/day) or pioglitazone or medications approved for treatment of NASH which has not been at a stable dose in the period from 90 days prior to the screening visit (V2A). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, treatment should be at a stable dose from time of biopsy until screening.
Treatment with GLP-1 RAs in the period from 90 days prior to the screening visit (V2A). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, any treatment with GLP-1 RAs from time of biopsy until screening (V2A).
Treatment with glucose-lowering agent(s) (other than GLP-1 RAs), lipid-lowering medication or weight loss medication not stable in the opinion of the investigator in the period from 90 days prior to the screening visit (V2A). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, treatment should be at a stable dose in the opinion of the investigator from time of biopsy until screening.

Ubicaciones

Hospital Britanico de Buenos Aires

Ciudad de Buenos Aires, Buenos Aires, Argentina

Hospital del Centenario

Rosario, Santa Fe, Santa Fe Province, Argentina

DIM Clinica Privada

Buenos Aires, Argentina

Centro Médico Viamonte SRL

CABA, Argentina

Hospital Italiano Departamento Hepatologia

CABA, Argentina

Glenny Corp. S.A

CABA, Argentina

Centro de Investigaciones Metabólicas

Capital Federal, Argentina

Centro de Investigaciones Metabólicas

Capital Federal, Argentina

Hospital El Cruce

Florencio Varela, Buenos Aires, Argentina

El efecto de semaglutida en sujetos con esteatohepatitis no alcohólica sin cirrosis

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Semaglutide

Placebo

Ubicaciones

Hospital Britanico de Buenos Aires

Hospital del Centenario

DIM Clinica Privada

Centro Médico Viamonte SRL

Hospital Italiano Departamento Hepatologia

Glenny Corp. S.A

Centro de Investigaciones Metabólicas

Centro de Investigaciones Metabólicas

Hospital El Cruce

Patrocinadores