Novo Nordisk A/S: Semaglutide 2.4 mg demonstrates superior improvement in both liver fibrosis and MASH resolution in the ESSENCE trial

Core Insights - Novo Nordisk announced positive results from part 1 of the ESSENCE trial, demonstrating the efficacy of semaglutide 2.4 mg in treating metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis [1][2][3] Group 1: Trial Results - The ESSENCE trial achieved its primary endpoints, showing a statistically significant improvement in liver fibrosis and resolution of steatohepatitis with semaglutide 2.4 mg compared to placebo [2] - At week 72, 37.0% of participants treated with semaglutide showed improvement in liver fibrosis without worsening steatohepatitis, compared to 22.5% in the placebo group [2] - Additionally, 62.9% of those on semaglutide achieved resolution of steatohepatitis without worsening liver fibrosis, versus 34.1% on placebo [2] Group 2: Drug Profile and Market Potential - Semaglutide 2.4 mg is a GLP-1 receptor agonist marketed as Wegovy®, indicated for chronic weight management in adults with obesity or overweight [6][7] - The drug has a well-tolerated safety profile consistent with previous trials, indicating its potential for broader application in treating MASH [3] - Novo Nordisk plans to file for regulatory approvals in the US and EU in the first half of 2025, with detailed results to be presented at a scientific conference in 2024 [3] Group 3: Disease Context - MASH is a serious and progressive liver disease affecting over 250 million people globally, with the number of individuals in advanced stages expected to double by 2030 [4] - Among those who are overweight or obese, more than one in three are also living with MASH, highlighting a significant unmet medical need [4]