A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

ReclutandoFase 3ClinicalTrials.gov

ID: NCT06318169Tipo: INTERVENTIONALInicio: 13 de mar de 2024Fin estimado: 1 de feb de 2029

Neumología Endocrinología Gastroenterología Enfermedades Infecciosas

Traducción no disponible, mostrando original

Resumen

The study will assess the efficacy and safety of 2 dose regimens of pegozafermin compared to placebo for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

Males or non-pregnant females aged between 18 and 80 years (inclusive) at time of signing the informed consent form (ICF)
Biopsy-confirmed MASH with fibrosis stage F2 or F3
Body mass index (BMI) at screening ≥25.0 kilograms (kg)/meters squared (m\^2) (≥23 kg/m\^2 for Asian participants).

Criterios de exclusión

Chronic liver diseases other than MASH
Evidence of cirrhosis on screening liver biopsy
Have type 1 diabetes or poorly controlled type 2 diabetes
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥250 units per liter (U/L)
Participants taking vitamin E (\>400 international units \[IU\]/day) or pioglitazone must be on stable dose for at least 6 months prior to Screening

Intervenciones

biological

Pegozafermin

Subcutaneous injection

other

Placebo

Subcutaneous injection

Ubicaciones

89bio Clinical Study Site

Buenos Aires, Argentina

89bio Clinical Study Site

RECRUITING

89bio Clinical Study Site

Buenos Aires, Argentina

89bio Clinical Study Site

RECRUITING

89bio Clinical Study Site

Buenos Aires, Argentina

89bio Clinical Study Site

RECRUITING

89bio Clinical Study Site

Buenos Aires, Argentina

89bio Clinical Study Site

RECRUITING

89bio Clinical Study Site

Buenos Aires, Argentina

89bio Clinical Study Site

RECRUITING

89bio Clinical Study Site

Caba, Argentina

89bio Clinical Study Site

RECRUITING

89bio Clinical Study Site

Capital Federal, Argentina

89bio Clinical Study Site

RECRUITING

89bio Clinical Study Site

Pilar, Argentina

89bio Clinical Study Site

RECRUITING

Patrocinadores

Principal89bio, Inc.

Contactos

ENLIGHTEN clinical trial

CONTACT

enlighten@89bio.com 1-415-432-9270

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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