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Novo Nordisk’s Semaglutide Hits Phase III Marks In NASH

 
• By Joseph Haas

The blockbuster GLP-1 analog demonstrated a capability for fibrosis reduction and disease resolution in the Phase III ESSENCE study. The firm plans to file for approval in 2025.

Novo Nordisk's semaglutide hits both primary endpoints in a Phase III NASH study (Shutterstock)

Novo Nordisk hit an important milestone on 1 November as it reported successful Phase III data for semaglutide in non-alcoholic steatohepatitis (NASH), marking the first time a GLP-1 receptor agonist demonstrated statistical significance for fibrosis reduction and/or NASH resolution. Analysts saw the results as largely comparable to the benefit seen with the first drug approval for NASH, Madrigal’s Rezdiffra.

Key Takeaways
  • Novo Nordisk reported top-line Phase III data showing that its GLP-1 agonist semaglutide can reduce fibrosis and clear NASH.

The data came from the 1,200-patient Phase III ESSENCE study, which is intended to back initial approval and in the longer-term provide hepatic benefit outcomes data for semaglutide 2.4mg...

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