This study focuses on patients with Metabolic Dysfunction-Associated Steatohepatitis (MASH) with compensated cirrhosis, a liver condition where inflammation and scarring occur due to metabolic problems. The study will test a new medication called pegozafermin (also known as BIO89-100) against placebo. The medication is given as a subcutaneous injection using a pre-filled syringe.
The purpose of this research is to determine if pegozafermin can help improve liver scarring and prevent the disease from getting worse in patients with MASH and cirrhosis. The study will look at how the liver tissue changes over time and track whether patients develop complications related to their liver disease.
During the study, participants will receive either pegozafermin injections or placebo. The treatment period will last for 60 months, during which patients will undergo various medical examinations to monitor their liver health. The maximum daily dose of pegozafermin that may be given is 30 milligrams, with a total maximum dose of 7200 milligrams over the entire study period.
1Initial treatment phase
You will receive either pegozafermin or a placebo (substance with no active ingredients) through subcutaneous injection (injection under the skin)
The treatment will continue for 24 months (2 years)
Your liver condition will be regularly monitored during this period
2Liver biopsy assessment
After 24 months of treatment, a liver biopsy will be performed
This procedure will help determine if there has been any improvement in liver scarring compared to your initial biopsy
3Ongoing monitoring
Regular blood tests will be conducted to measure liver function
You will undergo FibroScan examinations (a non-invasive test to measure liver stiffness)
ELF score (Enhanced Liver Fibrosis test) will be measured through blood samples
4Extended observation
The study will continue until October 2031
During this time, your liver health will be monitored for signs of disease progression
Regular checks will be performed for complications such as fluid in the abdomen or changes in mental function
Who Can Join the Study?
Age between 18 and 75 years old at the time of signing the consent form
Must have either:
Type 2 diabetes diagnosed at least 3 months before screening, or
At least two metabolic risk factors as specified by the study doctors
Must have confirmed liver condition through biopsy showing:
Stage F4 MASH (severe scarring of the liver)
Compensated cirrhosis (liver damage where the liver can still perform its main functions)
Body Mass Index (BMI) requirements:
For most participants: BMI between 25.0 and 50.0
For Asian participants: BMI between 23.0 and 50.0
Both men and women can participate
Women who are pregnant cannot participate
Who Cannot Join the Study?
Presence of decompensated liver cirrhosis (severe liver damage with complications)
History of hepatocellular carcinoma (liver cancer)
Other types of liver disease besides MASH (such as viral hepatitis, autoimmune liver disease)
Pegozafermin is a new investigational medication being studied for treating liver scarring (fibrosis) in people who have cirrhosis caused by Metabolic Dysfunction-Associated Steatohepatitis (MASH). This medication is designed to help improve liver health and potentially reverse some of the scarring that occurs in the liver. It works differently from traditional liver medications and represents a new approach to treating this liver condition.
Metabolic Dysfunction-Associated Steatohepatitis (MASH) with Compensated Cirrhosis – A chronic liver condition characterized by fat accumulation in the liver, accompanied by inflammation and scarring (fibrosis). The disease develops due to metabolic problems, often related to obesity, diabetes, or high blood pressure. In this condition, the liver has developed significant scarring (cirrhosis) but still maintains its essential functions (compensated state). The inflammation and damage continue to progress over time, causing gradual changes in liver structure. The compensated stage means that the liver can still perform most of its vital functions despite the damage.
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