Novo Nordisk has shared promising results from a late-stage study of semaglutide in patients with metabolic dysfunction-associated steatohepatitis (MASH), a progressive metabolic disease that affects the liver.
The ongoing ESSENCE trial has been evaluating the GLP-1 receptor agonist in adults with metabolic dysfunction-associated steatohepatitis (MASH) and moderate-to-advanced liver fibrosis.
Results from part one of the study showed that 37% of patients treated with once-weekly semaglutide 2.4mg achieved improvement in liver fibrosis with no worsening of steatohepatitis at week 72, compared to 22.5% of those randomised to receive placebo.
Additionally, 62.9% of semaglutide-treated patients achieved resolution of steatohepatitis with no worsening of liver fibrosis, compared to 34.1% in the placebo group.
MASH, also known as nonalcoholic steatohepatitis, is caused by too much fat in the liver and is associated with an increased risk of advanced liver disease, including liver cancer.
The disease is closely linked with being overweight as well as conditions such as type 2 diabetes, with more than one in three people who are overweight or living with obesity affected.
Semaglutide, marketed under brand names such as Ozempic and Wegovy, is already approved for a range of indications, including diabetes, weight management and cardiovascular risk reduction.
Novo said it expects to file for regulatory approvals of semaglutide in MASH in the US and EU in the first half of 2025.
Martin Holst Lange, executive vice president and head of development at Novo, 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.”
The results come less than two months after Novo entered into a multi-year partnership worth $600m with NanoVation Therapeutics to advance genetic medicines for cardiometabolic and rare diseases.
The deal combines Novo’s capabilities in the two areas with NanoVation’s proprietary long-circulating lipid nanoparticle technology for RNA delivery to cells outside of the liver.