What is the Purpose of this Study?
The purpose of this study is to learn about the safety, effectiveness, and long-term outcomes of an experimental drug called pegozafermin in people with compensated cirrhosis (advanced scarring of the liver) due to metabolic dysfunction-associated steatohepatitis (MASH) when compared to a placebo (inactive substance). The study will assess the effect of pegozafermin compared to placebo on reversal/regression of fibrosis (scarring tissues) in the liver at 24 months. Study procedures include pegozafermin and/or placebo administration, imaging, blood draws, liver biopsies, electrocardiograms, and urine collection. Pegozafermin is a hormone made from protein that naturally occurs in the body and works on the metabolism of fats and glucose (sugar). In previous studies, pegozafermin has shown the ability to lower blood triglycerides (a type of fat or lipid found in the blood) and decrease abnormal fat storage in the liver. The study will also measure blood biomarkers to help monitor the safety and effectiveness of the study drug. A biomarker is a biological molecule found in blood, other body fluids or tissues that may be a sign of a condition or disease and can be used to predict response to a specific treatment.
Eligibility
- * Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the informed consent form (ICF).
- * Participants must have type 2 diabetes mellitus diagnosed at least 3 months before screening or at least 2 metabolic risk factors.
- * Biopsy-confirmed fibrosis stage F4 MASH (NASH Clinical Research Network (CRN) system) with compensated cirrhosis.
- * Body mass index (BMI) at screening ≥25.0 (≥23.0 for Asian participants) and \<50.0 kilograms (kg)/meters squared (m\^2).
Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects with Compensated Cirrhosis due to Metabolic Dysfunction-Associated Steatohepatitis