Novo Nordisk Reports Headline Results From Part 1 Of ESSENCE Trial With Semaglutide

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(RTTNews) - Novo Nordisk (NVO) announced the headline results from part 1 of the ongoing ESSENCE trial, a phase 3, 240-week, double-blinded trial in 1,200 adults with metabolic dysfunction-associated steatohepatitis and moderate to advanced liver fibrosis. Part 1 of the trial evaluated the effect of once-weekly semaglutide 2.4 mg on liver tissue compared to placebo on top of standard of care for the first 800 randomised people at 72 weeks. The trial achieved primary endpoints by demonstrating a statistically significant and superior improvement in liver fibrosis with no worsening of steatohepatitis, as well as resolution of steatohepatitis with no worsening of liver fibrosis with semaglutide 2.4 mg compared to placebo. At week 72, 37.0% of people treated with semaglutide 2.4 mg achieved improvement in liver fibrosis with no worsening of steatohepatitis compared to 22.5% on placebo.

Novo Nordisk expects to file for regulatory approvals in the US and EU in the first half of 2025. Part 2 of the ESSENCE trial will continue with expected readout in 2029.

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