Novo Nordisk’s Wegovy Shows Promise in Treating Liver Disease, Potential for Regulatory Approval in 2025
Novo Nordisk A/S (NVO) has announced positive results from the first part of its ongoing ESSENCE Phase 3 trial, evaluating the effectiveness of its drug Wegovy (semaglutide 2.4 mg) in treating metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis.
The 240-week trial, conducted on 1,200 adults, focused on the impact of once-weekly subcutaneous semaglutide 2.4 mg compared to placebo, alongside standard of care, for the first 800 participants over a 72-week period. The trial achieved its primary endpoints, demonstrating a statistically significant and superior improvement in liver fibrosis with no worsening of steatohepatitis and resolution of steatohepatitis with no worsening of liver fibrosis with semaglutide 2.4 mg compared to placebo.
At the 72-week mark, 37.0% of individuals treated with semaglutide 2.4 mg experienced improvement in liver fibrosis with no worsening of steatohepatitis, compared to 22.5% on placebo. Furthermore, 62.9% of those treated with semaglutide 2.4 mg achieved resolution of steatohepatitis with no worsening of liver fibrosis, compared to 34.1% on placebo.
The trial concluded that semaglutide 2.4 mg exhibited a safe and well-tolerated profile, consistent with previous trials for the drug. Based on these encouraging results, Novo Nordisk plans to file for regulatory approvals in the U.S. and EU in the first half of 2025. Detailed results from the ESSENCE trial are expected to be presented at a scientific conference in 2024, with the second part of the trial set to conclude in 2029.
This update comes as the FDA has revised its shortage list to indicate that the .25 mg starter dose of semaglutide-based obesity medication Wegovy is now available in the U.S. This follows the recent removal of Eli Lilly And Co’s (LLY) tirzepatide from the shortage list.
In October, Novo Nordisk shared data from the SOUL Phase 3 cardiovascular outcomes trial, which evaluated subcutaneous once-weekly semaglutide 2.4 mg. The trial achieved its primary objective, demonstrating a statistically significant and superior reduction in major adverse cardiovascular events (MACE) of 14% for individuals treated with oral semaglutide compared to placebo. MACE includes events such as cardiac arrest, stroke, heart failure, or cardiovascular death.
The positive results from the ESSENCE trial, combined with the ongoing availability of Wegovy and the promising cardiovascular outcomes data from SOUL, suggest a significant potential for semaglutide 2.4 mg in addressing both metabolic dysfunction-associated steatohepatitis and cardiovascular health.
