Novo Nordisk (NYSE:NVO) has reported another successful trial for its Wegovy (or Semaglutide) drug, this time in the treatment of fibrosis caused by the fatty liver condition known as MASH.
Headline results from part 1 of the ongoing ESSENCE trial, a phase three, 240-week, double-blinded trial in 1,200 adults with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis, showed it met its primary endpoint.
Compared to placebo there was a statistically significant and superior improvement in liver fibrosis with no worsening of steatohepatitis, said the Danish group which is Europe's largest company.
Treated with semaglutide 2.4 mg, 37% of the triallists saw an improvement in liver fibrosis at 72 weeks with no worsening of steatohepatitis compared to 22.5% on placebo.
A further 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.
“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, head of Development at Novo Nordisk (NYSE:NVO).
“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 (NYSE:NVO) said it expects to file for regulatory approvals in the US and EU in the first half of 2025.
MASH is a progressive, metabolic disease affecting the liver, which can be fatal if not properly managed.
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.