62.9% of patients who received semaglutide experienced relief of steatohepatitis! Novo Nordisk announces ESSENSE test results

Novo Nordisk announced today the results of the first part of the ongoing Phase 3 ESSENSE trial. The first part evaluated the effect of weekly subcutaneous injection of 2.4 mg semaglutide on liver tissue histology in patients with metabolic dysfunction associated steatohepatitis (MASH) and moderate to advanced liver fibrosis (stage 2 or 3), and compared it with placebo. The results were announced at the 75th American Association for the Study of the Liver (AASLD) - Liver Conference.

The experiment achieved two main endpoints. Compared with placebo, 2.4 milligrams of semaglutide showed significant and superior improvement in liver fibrosis in MASH patients, and fatty hepatitis did not worsen. At the same time, fatty hepatitis was relieved and liver fibrosis did not worsen. At week 72, the primary endpoint showed that 62.9% of patients receiving 2.4 mg semaglutide treatment experienced relief of steatohepatitis without worsening of liver fibrosis, compared to 34.1% of patients receiving placebo treatment. 37.0% accept 2.4

Patients treated with MG semaglutide showed improvement in liver fibrosis and no deterioration of steatohepatitis, compared to 22.5% of patients treated with placebo. Overall, the secondary endpoint showed that 32.8% of patients receiving 2.4 milligrams of semaglutide experienced relief of fatty liver and improvement in liver fibrosis (compared to 16.2% of patients receiving placebo treatment).

At The Liver Meeting ®  The initial data shared above indicate that 2.4 milligrams of semaglutide can slow down the progression of MASH and reverse existing liver damage, "said Arun Sanyal, MD, lead researcher of the study and director of the Stravitz Sanyal Institute for Liver Disease and Metabolic Health at Virginia Commonwealth University. The ESSENSE data may represent a key finding for patients treated with MASH, which is estimated to affect approximately 1/20 of adults in the United States One in every 20 adults in the United States suffers from metabolic dysfunction associated steatohepatitis (MASH), and in all cases, 20% of MASH will develop into cirrhosis.

In addition to meeting the two primary endpoints, the secondary endpoint also showed that patients treated with 2.4 milligrams of semaglutide showed improvement in pre specified non-invasive testing (NIT) compared to placebo, reflecting histological benefits. Additional data shows improvements in liver enzymes (including ALT, AST, and GGT) and enhanced liver fibrosis (ELF) testing. In the experiment, the safety of 2.4 mg of semaglutide seems to be similar to previous trials of 2.4 mg of semaglutide in patient populations in other treatment areas. Supportive secondary endpoints showed improvement in liver enzymes, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma glutamyl transferase (GGT), as well as enhanced liver fibrosis (ELF) testing.

We are pleased to see the ESSENSE data presented at AASLD, which supports increasing clinical evidence that semaglutide 2.4 mg can be used to treat patients with chronic diseases such as MASH, "said Anna, Senior Vice President of Clinical Development, Medical and Regulatory Affairs at Novo Nordisk

Dr. Windle stated. "These data are the cornerstone of our research, which is based on our understanding of how MASH and cardiac metabolic diseases (such as type 2 diabetes, obesity, dyslipidemia and hypertension) are related."