89bio BIO89-100-131 (Metabolic Dysfunction-Associated Steatohepatitis) - 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 with Metabolic Dysfunction Associated Steatohepatitis (MASH).
What is the Condition Being Studied?
Metabolic Dysfunction Associated Steatohepatitis (MASH); Nonalcoholic Steatohepatitis (NASH)
Who Can Participate in the Study?
Adults ages 18-75 who:
- 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.
Age Group
Adults
What is Involved?
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:
- Electrocardiograms
- Blood draws
- Questionnaires
Study Details
Full Title
A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects with Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
Principal Investigator
Amreen M. Dinani, MD, FRCPC
Hepatologist
Protocol Number
IRB:
PRO00115755
NCT:
NCT06318169
Phase
Phase
III
ClinicalTrials.gov
View on ClinicalTrials.gov
Enrollment Status
Open for Enrollment