BIO89-100-132 (Metabolic Dysfunction-Associated Steatohepatitis MASH)_Dinani

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.

Who Can Participate?

Eligibility

Adults ages 18-75 who are diagnosed with compensated liver cirrhosis. For more information, contact that study team at lauren.roberson@duke.edu.

Age Range

18-75

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

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
  • Have blood draws
  • Have physical exams
  • Fill out questionnaires

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

No

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

Amreen
Dinani

Protocol Number

PRO00116849

NCT ID

NCT06419374

Phase

III

Enrollment Status

Open to Enrollment