FX.co ★ Novo Nordisk Reports Headline Results From Part 1 Of ESSENCE Trial With Semaglutide

Novo Nordisk (NVO) has released the headline results from the first part of its ongoing ESSENCE trial. This phase 3 trial spans 240 weeks and is being conducted on 1,200 adults diagnosed with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis. In the first segment of the trial, researchers assessed the effects of a once-weekly dose of semaglutide at 2.4 mg on liver tissue compared to a placebo, administered alongside the standard care treatment, in the initial 800 participants over a period of 72 weeks. The trial successfully met its primary objectives, showing a statistically significant and enhanced improvement in liver fibrosis without a deterioration of steatohepatitis, and resolution of steatohepatitis without a worsening of liver fibrosis when using semaglutide 2.4 mg as opposed to placebo. By week 72, 37.0% of participants treated with semaglutide 2.4 mg experienced an improvement in liver fibrosis without a worsening of steatohepatitis, compared to 22.5% of those given a placebo.

Novo Nordisk plans to apply for regulatory approval in both the US and the EU by the first half of 2025. The second part of the ESSENCE trial will proceed, with results anticipated by 2029.