Novo Nordisk's Semaglutide Meets Primary Endpoint in Phase 3 Trial for MASH, Demonstrating Significant Liver Fibrosis Improvement

Intelligent Finance APP learned that Novo Nordisk (NVO.US) announced on Friday that a pivotal Phase 3 trial designed to test its weight-loss therapy semaglutide in patients with metabolic dysfunction-associated steatohepatitis (MASH) related to liver disease had met the primary endpoint.

Novo Nordisk cited data from the 72-week Part 1 of its ESSENCE trial, indicating that the evaluated 2.4 mg dose of semaglutide showed safety and good tolerability. This two-part trial includes patients with MASH and liver fibrosis.

ESSENCE Achieves Primary Endpoint: Patients Treated with Semaglutide Show Statistically Significant and Superior Improvement in Liver Fibrosis Without Worsening of Fibrosis or Steatohepatitis (an Advanced Form of Nonalcoholic Fatty Liver Disease).

The company said it would apply for approval of the drug from US and EU regulators in the first half of 2025. The 240-week second part of the ESSENCE trial is ongoing, with data expected to be released in 2029.