Novo Nordisk's Wegovy Therapy Sparks Controversy: Phase 3 Trials Show Significant Reduction in Liver Fibrosis

Novo Nordisk recently announced primary results from Part 1 of its ongoing pivotal Phase 3 clinical trial of ESSENCE. A detailed analysis of the study showed that Wegovy (semaglutide), a weight-loss therapy developed by the company, significantly reduced symptoms of liver fibrosis in patients with metabolic dysfunctions associated with steatohepatitis (MASH) and promoted resolution of steatohepatitis compared to placebo. Novo Nordisk plans to submit regulatory applications for Wegovy for the treatment of MASH to regulators in the United States and the European Union in the first half of 2025. Detailed data from the ESSENCE trial are expected to be presented at a scientific meeting in the near future. In addition, Part 2 of the trial is continuing and final results are expected in 2029.

The ESSENCE trial is a pivotal Phase 3 clinical trial whose primary objective is to evaluate the efficacy and safety of Wegovy therapy with a subcutaneous injection of 2.4 mg of semaglutide once a week compared to placebo in adult patients with MASH with moderate to severe liver fibrosis (stage 2 or 3). Detailed analysis of the trial results showed that Wegovy not only showed significant effects in improving liver fibrosis compared to placebo, but also achieved regression of steatohepatitis without aggravating it. Specifically, at week 72, 37.0% of patients in the Wegovy group had improved liver fibrosis without worsening steatohepatitis, compared with only 22.5% in the placebo group. In addition, 62.9% of patients in the Wegovy group experienced resolution of steatohepatitis without worsening liver fibrosis, compared with 34.1% in the placebo group. These data further support the potential benefits of Wegovy in treating MASH.