A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

ReclutandoFase 3ClinicalTrials.gov

ID: NCT06215716Tipo: INTERVENTIONALInicio: 1 de dic de 2023Fin estimado: 1 de nov de 2032

Neumología Endocrinología Gastroenterología Enfermedades Infecciosas

Traducción no disponible, mostrando original

Resumen

This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with non-cirrhotic NASH/MASH and fibrosis stage 2 or 3 (F2 or F3). The study will enroll subjects in two cohorts for a total samples size of 1650 subjects.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

Males and non-pregnant, non-lactating females between 18 - 80 years of age inclusive, based on the date of the screening visit.
Previous history or presence of 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose) or type 2 diabetes.
Cohort 1: Biopsy-proven NASH/MASH. Must have had a liver biopsy obtained ≤ 180 days prior to screening with fibrosis stage 2 or 3 and a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components:
Steatosis (scored 0 to 3),
Ballooning degeneration (scored 0 to 2), and
Lobular inflammation (scored 0 to 3).

Criterios de exclusión

Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results.
Presence of cirrhosis on liver biopsy (fibrosis stage 4).
Type 1 or uncontrolled Type 2 diabetes.

Intervenciones

drug

Efruxifermin

Administered by subcutaneous injection

drug

Placebo

Administered by subcutaneous injection

Ubicaciones

Akero Clinical Study Site

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Akero Site 0307

RECRUITING

Akero Clinical Study Site

La Plata, Buenos Aires, Argentina

Akero Site 0304

RECRUITING

Akero Clinical Study Site

Ramos Mejía, Buenos Aires, Argentina

Akero Site 0303

RECRUITING

Akero Clinical Study Site

Buenos Aires, Distrito Federal, Argentina

Akero Site 0306

RECRUITING

Akero Clinical Study Site

Buenos Aires, Argentina

Akero Site 0305

RECRUITING

Akero Clinical Study Site

Buenos Aires, Argentina

Akero Site 0302

RECRUITING

Akero Clinical Study Site

Buenos Aires, Argentina

Akero Site 0301

RECRUITING

Patrocinadores

PrincipalAkero Therapeutics, Inc

Contactos

Akero Study Director

CONTACT

AkeroSynchrony@akerotx.com 650-487-6488

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