89bio BIO89-100-131 (Metabolic Dysfunction-Associated Steatohepatitis) - Clinical Trial

¿Cuál es el Propósito de este estudio?

We are doing this study to find out if an experimental drug called pegozafermin (the study drug) is a safe and effective option for people with Metabolic Dysfunction Associated Steatohepatitis (MASH).

¿Cuál es la Condición que se está estudiando?

Metabolic Dysfunction Associated Steatohepatitis (MASH); Nonalcoholic Steatohepatitis (NASH)

¿Quién puede participar en el Estudio?

Adultos de 18 a 75 años que:

Are diagnosed with MASH confirmed by liver biopsy
Have fibrosis stage F2 or F3
Have at least 2 of the following risk factors: waist circumference >37 inches for males or >32 inches for females, body mass index >25 (>23 if Asian), diagnosis of Type 2 Diabetes, hypertriglyceridemia, HDL cholesterol 40 for males or 50 for females, hypertension

For more information, contact the study team at mike.elgasim@duke.edu.

Grupo etario

Adultos

¿Qué Implica?

If you choose to join this study, you will get a random assignment (by chance) to 1 of 3 study groups. Depending on your assignment, you will:

Take a 44 mg dose of the study drug once every 2 weeks; OR
Take a 30 mg dose of the study drug once per week; OR
Take a placebo (inactive substance that has no drug in it)

The study will last about 40 months and involve 14 visits to our clinic. Study procedures at these visits will include the following:

Electrocardiogramas
Extracción de sangre
Cuestionarios

Detalles del Estudio

Título Completo

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

Investigador Principal