Novo Nordisk’s Semaglutide Tops Madrigal’s Rezdiffra In NASH

Greater Combined Effect Seen In Phase III Trials

The firm revealed that an analysis of its Phase III ESSENCE trial combining fibrosis reduction and NASH resolution showed a higher effect over placebo than in Madrigal’s pivotal trial.

Novo Nordisk presented more data for semaglutide in NASH at AASLD (Shutterstock)

New data from Novo Nordisk’s Phase III ESSENCE study of semaglutide in non-alcoholic steatohepatitis (NASH) unveiled at the American Association for the Study of Liver Disease conference on 19 November showed that the GLP-1 agonist performed better than Madrigal’s Rezdiffra (resmetirom), the only approved NASH drug, in an analysis combining outcomes on the two primary endpoints, reduction of liver fibrosis and resolution of NASH.

Key Takeaways
  • Novo Nordisk presented new data from its Phase III ESSENCE study of semaglutide in NASH at AASLD, pointing to a possible efficacy advantage versus Rezdiffra.
  • Semaglutide, slated for US and EU filings for NASH during the first half of 2025, performed better in Phase III than the approved Madrigal drug on an analysis combining the two primary endpoints for NASH

The Danish pharma confirmed its plans to file semaglutide for approval in NASH – also known as metabolic dysfunction-associated steatohepatitis (MASH) – for US and EU approval during the first half of 2025, as it indicated when it released

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