BIO89-100-132 (Metabolic Dysfunction-Associated Steatohepatitis MASH)_Dinani - 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.
Age Group
Adults
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
- Have blood draws
- Have physical exams
- 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
Amreen M. Dinani, MD, FRCPC
Hepatologist
Protocol Number
IRB:
PRO00116849
NCT:
NCT06419374
Phase
Phase
III
ClinicalTrials.gov
View on ClinicalTrials.gov
Enrollment Status
Open for Enrollment