MAFLD and MASH

Metabolic-dysfunction associated fatty liver disease (MAFLD) refers to a spectrum of hepatic lipid disorders characterized by hepatic steatosis with no known secondary cause. It is subcategorized into (a) fatty liver (MAFLD), defined as the presence of steatosis in the absence of histological evidence of hepatocellular injury, and (b) metabolic-dysfunction associated steatohepatitis (MASH). MASH can occur with or without fibrosis but may progress to fibrosis and cirrhosis. MAFLD is generally associated with energy metabolism pathologies, including obesity, dyslipidemia, diabetes, and metabolic syndrome.  

MAFLD is estimated to affect over 30% of Americans and almost 40% of the global population. Around 20 to 30% of these patients will eventually develop MASH. Patients with obesity or diabetes are especially vulnerable to both conditions: at least 50% of people with obesity and 65% of people with type 2 diabetes mellitus have MAFLD. 

NuSirt’s work on in vitro and in vivo models of MASH indicate that TRIPLN^® suppresses fat production, fibrosis, and inflammation. These data provide strong evidence that TRIPLN^® reverses symptoms of steatohepatitis, which can help those with MASH and prevent those with MAFLD from progressing to MASH. To further this research, we conducted a phase 2 clinical trial in MAFLD patients and found that TRIPLN^® was most effective at reducing steatohepatitis in the group with the highest ALT levels, corresponding to more severe disease.