Danish pharmaceutical firm Novo Nordisk has announced positive results for its weight loss drug Wegovy (semaglutide) 2.4mg, from part 1 of the ongoing Phase 3 ESSENCE trial.
ESSENCE is a 240-week, double-blinded study in 1,200 adults with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis (stage 2 or 3).
Part 1 of the study evaluated the effect of semaglutide 2.4mg on liver tissue compared to placebo on top of standard of care for the first 800 randomised people at 72 weeks.
In the phase 3 study, semaglutide 2.4mg achieved its primary endpoints showing a statistically significant and superior improvement in liver fibrosis with no worsening of steatohepatitis.
Also, the drug resulted in the resolution of steatohepatitis with no worsening of liver fibrosis compared to placebo.
Novo Nordisk executive vice president and development head Martin Holst Lange said: “We are very pleased about the ESSENCE clinical trial results and the potential of semaglutide to help people living with MASH.
“Among people with overweight or obesity, one in three live with MASH. This has a serious impact on their health and represents a significant unmet need.”
Semaglutide is a GLP-1 receptor agonist marketed as Wegovy, for chronic weight management in adults with obesity, as an adjunct to a reduced calorie diet and increased physical activity.
In the US, Wegovy is approved to reduce the risk of MACE in adults with established cardiovascular disease and either obesity or overweight, alongside diet and physical activity.
Also, the drug is approved to reduce excess body weight and maintain long-term weight reduction in adults and children aged 12 years and older with obesity and overweight.
In the study, 37% of people treated with semaglutide 2.4mg achieved improvement in liver fibrosis with no worsening of steatohepatitis at week 72, compared to 22.5% on placebo.
Also, 62.9% of people treated with semaglutide 2.4mg achieved resolution of steatohepatitis with no worsening of liver fibrosis compared to 34.1% on placebo.
Novo Nordisk said that its semaglutide 2.4mg showed a safe and well-tolerated profile in the Phase 3 study, in line with previous semaglutide 2.4mg trials.
The Danish drugmaker aims to file for regulatory approvals in the US and EU in the first half of 2025, with plans to present detailed results from ESSENCE at a scientific conference this year.
