The purpose of this study is to test if an investigational study drug, pegozafermin, is safe and effective in treating patients with MASH metabolic dysfunction-associated steatohepatitis (MASH).
Investigational means that the drug has not been approved by regulatory authorities such as the U.S. Food and Drug Administration (FDA).
MASH is the most severe form of nonalcoholic fatty liver disease (NAFLD) and is characterized by an excessive accumulation of fat in the liver, liver cell injury and inflammation, ultimately leading to fibrosis. Pegozafermin is being developed to reduce MASH.
If an individual agrees to participate in this study and meets all the requirements, participants will be randomly assigned (like rolling dice) to one of three study groups:
a. Pegozafermin 30 mg (once weekly)
b. Pegozafermin 44 mg (once every two weeks)
c. Placebo (no active drug) once weekly or once every two weeks.
Study participants will also answer questionnaires, provide blood samples, Fibroscan, X-Ray, Liver Biopsy, ultrasound, and optional blood pressure monitoring.
Participation in this study will last for up to 40 months and participants will be compensated for their time.
Detailed eligibility will be reviewed when contacting the study team.