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

ReclutandoFase 3ClinicalTrials.gov

ID: NCT06419374Tipo: INTERVENTIONALInicio: 24 de may de 2024Fin estimado: 1 de ago de 2031

Neumología Endocrinología Gastroenterología Enfermedades Infecciosas

Traducción no disponible, mostrando original

Resumen

The study will assess the efficacy and safety of pegozafermin administered in participants with compensated cirrhosis due to MASH (biopsy-confirmed fibrosis stage F4 MASH \[previously known as nonalcoholic steatohepatitis, NASH\]).

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the informed consent form (ICF).
Participants must have type 2 diabetes mellitus diagnosed at least 3 months before screening or at least 2 metabolic risk factors.
Biopsy-confirmed fibrosis stage F4 MASH (NASH Clinical Research Network (CRN) system) with compensated cirrhosis.
Body mass index (BMI) at screening ≥25.0 (≥23.0 for Asian participants) and \<50.0 kilograms (kg)/meters squared (m\^2).

Criterios de exclusión

Liver disorder other than MASH.
History or evidence of hepatic decompensation.
History or evidence of hepatocellular carcinoma.
Have type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus.
ALT or aspartate aminotransferase (AST) ≥250 units per liter (U/L).
Participants taking vitamin E (\>400 international units \[IU\]/day) must be on stable dose for at least 6 months prior to screening.

Intervenciones

biological

Pegozafermin

Subcutaneous injection

drug

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

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