Positive results from ESSENCE trial of Wegovy (semaglutide 2.4 mg) in patients with metabolic dysfunction-associated steatohepatitis (MASH)- Novo Nordisk
Novo Nordisk announced the headline results from part 1 of the ongoing ESSENCE trial, a pivotal phase III, 240-week, double-blinded trial in 1,200 adults with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis (stage 2 or 3).
Part 1 of the ESSENCE trial evaluated the effect of once weekly semaglutide 2.4 mg on liver tissue (histology) compared to placebo on top of standard of care for the first 800 randomised people at 72 weeks. The trial achieved its primary endpoints by demonstrating a statistically significant and superior improvement in liver fibrosis with no worsening of steatohepatitis, as well as resolution of steatohepatitis with no worsening of liver fibrosis with semaglutide 2.4 mg compared to placebo. At week 72, 37.0% of people treated with semaglutide 2.4 mg achieved improvement in liver fibrosis with no worsening of steatohepatitis compared to 22.5% on placebo. 62.9% of people treated with semaglutide 2.4 mg achieved resolution of steatohepatitis with no worsening of liver fibrosis compared to 34.1% on placebo. In the trial, semaglutide 2.4 mg appeared to have a safe and well-tolerated profile in line with previous semaglutide 2.4 mg trials.
“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, executive vice president and head of Development at Novo Nordisk. “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.” Novo Nordisk expects to file for regulatory approvals in the US and EU in the first half of 2025. The detailed results from ESSENCE will be presented at a scientific conference in 2024. Part 2 of the ESSENCE trial will continue with expected readout in 2029.
About the ESSENCE trial ; The trial achieved its primary endpoints by demonstrating a statistically significant and superior improvement in liver fibrosis with no worsening of steatohepatitis, as well as resolution of steatohepatitis with no worsening of liver fibrosis with semaglutide 2.4 mg compared to placebo. At week 72, 37.0% of people treated with semaglutide 2.4 mg achieved improvement in liver fibrosis with no worsening of steatohepatitis compared to 22.5% on placebo2. 62.9% of people treated with semaglutide 2.4 mg achieved resolution of steatohepatitis with no worsening of liver fibrosis compared to 34.1% on placebo.
Novo did not provide further study details, leaving it unclear how well semaglutide performed on a variety of secondary measures, or how many people might’ve stopped treatment due to side effects. Detailed results will be presented at a medical meeting later in 2024. The trial’s second phase will also continue for several years to assess semaglutide’s ability to prevent cirrhosis, a common MASH complication.
“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, executive vice president and head of Development at Novo Nordisk. “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.” Novo Nordisk expects to file for regulatory approvals in the US and EU in the first half of 2025. The detailed results from ESSENCE will be presented at a scientific conference in 2024. Part 2 of the ESSENCE trial will continue with expected readout in 2029.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
2 mins