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