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2nd New Fatty Liver Drug Pegozafermin in Phase 3
 
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EASL: Week 48 results from the phase 2b ENLIVEN extension study investigating pegozafermin for the treatment of metabolic dysfunction-associated steatohepatitis with fibrosis - (06/12/24)  
Pegozafermin (BIO89-100)  
Pegozafermin is an investigational FGF21 analog engineered using glycoPEGylation technology with site-specific mutations designed to recapitulate the activity profile and prolong the half-life of the native FGF21 hormone, which may address underlying metabolic issues that drive liver and cardiometabolic diseases, such as MASH and SHTG (severe hypertrglyceremia).  
Overview  
Metabolic dysregulation can result in a multitude of liver and cardiometabolic disorders, including MASH and SHTG.  
FGF21  
Fibroblast growth factor 21 (FGF21) is an endogenous hormone primarily secreted from the liver that acts as a master metabolic regulator with broad effects on energy expenditure and glucose and lipid metabolism. The effects of FGF21 are mediated through activation of its receptors (FGFR1, 2, or 3c) with co-receptor β-Klotho in tissues throughout the body, including the liver, adipose, pancreas, muscle, and brain.  
Expanded Access Policy  
Current Trials  
Study Evaluating the Safety, Efficacy and Tolerability of BIO89-100 in Subjects With Biopsy-confirmed Nonalcoholic Steatohepatitis (NASH) (ENLIVEN)
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