Novo Nordisk's semaglutide (Wegovy) has shown promising results in a Phase III trial for the treatment of liver fibrosis and metabolic dysfunction-associated steatohepatitis (MASH). The trial demonstrated a statistically significant and superior improvement in liver fibrosis without worsening of steatohepatitis, as well as resolution of steatohepatitis without worsening of liver fibrosis, compared to placebo.
ESSENCE Trial Details
The ESSENCE trial, a pivotal Phase III study, involved 1,200 adults with MASH and moderate to advanced liver fibrosis (stage 2 or 3). The first part of the trial, involving 800 participants, evaluated the effect of once-weekly semaglutide 2.4 mg on liver tissue (histology) compared to placebo on top of standard of care over 72 weeks. The trial met its primary endpoints, demonstrating the efficacy of semaglutide in improving liver fibrosis and resolving steatohepatitis.
"We are very pleased about the ESSENCE clinical trial results and the potential of semaglutide to help people living with MASH," said Martin Holst Lange, MD, PhD, executive vice president and head of development at Novo Nordisk.
Clinical Significance and Future Plans
The results of the ESSENCE trial hold significant clinical implications, as MASH affects a substantial portion of individuals with overweight or obesity. It is estimated that more than 250 million people live with MASH, and the number of individuals in advanced stages of the disease is expected to double by 2030. Semaglutide 2.4 mg appeared to have a safe and well-tolerated profile in line with previous trials.
Novo Nordisk anticipates filing for regulatory approvals in the U.S. and EU in the first half of 2025. Detailed results from the ESSENCE trial will be presented at a scientific conference in 2024. The second part of the ESSENCE trial is ongoing, with expected results in 2029.
Broader Implications of Semaglutide
Semaglutide has already been approved for cardiovascular disease prevention in individuals with obesity. It has also shown promise in lowering the risk of kidney disease, combating substance abuse, and treating dementia and pancreatitis. An approval for MASH could significantly increase the drug's market value, which currently stands at $112.5 million.
