BIO89-100-132 (Metabolic Dysfunction-Associated Steatohepatitis MASH) - Clinical Trial

What is the Purpose of this Study?

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 who have compensated liver cirrhosis due to MASH.

What is the Condition Being Studied?

Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Who Can Participate in the Study?

Adults ages 18-75 who are diagnosed with compensated liver cirrhosis.

For more information, contact that study team at lauren.roberson@duke.edu.

Grupo etario
Adultos

What is Involved?

If you choose to join this study, you will get a random assignment (like a coin flip) to either take the study drug or a placebo (inactive substance with no drug in it).

Regardless of your study assignment, you will:

  • Come to our clinic about 13 times over the course of 64 months
  • Realizar extracciones de sangre
  • Someterse a exámenes físicos
  • Fill out questionnaires

Study Details

Full Title
A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects with Compensated Cirrhosis due to Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Principal Investigator
Especialista en hepatología
Protocol Number
IRB: PRO00116849
NCT: NCT06419374
Phase
Phase III
ClinicalTrials.gov
Estado de inscripción
Abierto para inscripción