Novo Nordisk's semaglutide has demonstrated superior efficacy in achieving both fibrosis reduction and NASH resolution compared to Madrigal's Rezdiffra, according to an analysis of Phase III trial data. The findings, revealed at a recent medical conference, suggest that semaglutide could offer a more effective treatment option for patients with non-alcoholic steatohepatitis (NASH).
The analysis focused on data from Novo Nordisk's Phase III ESSENCE trial, which evaluated the impact of semaglutide on NASH resolution and fibrosis improvement. The results were then compared to data from Madrigal's pivotal trial for Rezdiffra. The comparison revealed that semaglutide exhibited a greater combined effect on fibrosis reduction and NASH resolution compared to placebo than observed in Madrigal’s Rezdiffra trial.
NASH is a progressive liver disease characterized by inflammation and fat accumulation in the liver, which can lead to cirrhosis, liver failure, and hepatocellular carcinoma. With the increasing prevalence of obesity and type 2 diabetes, NASH has become a significant global health concern. Current treatment options are limited, highlighting the urgent need for more effective therapies.
The ESSENCE trial is a Phase III study evaluating the efficacy and safety of semaglutide in patients with NASH. The trial's primary endpoints include NASH resolution without worsening of fibrosis and improvement in fibrosis stage without worsening of NASH. Secondary endpoints assess changes in liver enzymes, metabolic parameters, and histological features of NASH.
While detailed data from the ESSENCE trial is still being presented and analyzed, the initial findings suggest that semaglutide holds promise as a potential treatment for NASH. Further research is needed to fully elucidate the long-term benefits and risks of semaglutide in this patient population.