The US Food and Drug Administration (FDA) has granted accelerated approval for Novo Nordisk’s Wegovy (semaglutide 2.4 mg) for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis (stages F2–F3), but without cirrhosis.

Mash is a serious, progressive, metabolic disease affecting the liver, which can be fatal if not properly managed.

The additional indication for Wegovy is based on a supplemental New Drug Application (sNDA) and requires its use in combination with a reduced-calorie diet and increased physical activity.

According to the company, the approval was supported by data from part 1 of the ESSENCE trial, where Wegovy demonstrated 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 compared to placebo.

At week 72, 36.8 percent of people treated with Wegovy achieved improvement in liver fibrosis with no worsening of steatohepatitis compared to 22.4 percent treated with placebo.

Nearly 63 percent of people treated with Wegovy achieved resolution of steatohepatitis with no worsening of liver fibrosis compared to 34.3 percent treated with placebo.

“Wegovy is now uniquely positioned as the first and only GLP-1 treatment approved for MASH, complementing the already proven weight loss, cardiovascular benefits, and extensive body of evidence linked to semaglutide,” said Martin Holst Lange, executive vice president, chief scientific officer, and head of Research and Development, at Novo Nordisk.

Lange highlighted that MASH poses a significant health burden, affecting one in three people with overweight or obesity worldwide. In the US, it is estimated that around 22 million people are living with the condition.  

“With the approval of Wegovy for MASH, we provide a new treatment to people living with MASH that not only halts the disease activity but helps reverse the damage caused to the liver,” he added.

Wegovy is now available in the US for the treatment of MASH. Based on the ESSENCE trial, Novo Nordisk has also filed for regulatory approval in the EU (February 2025) and Japan (May 2025). Part 2 of the ESSENCE trial, expected to read out in 2029, aims to show whether semaglutide 2.4 mg lowers the risk of liver-related clinical events over 240 weeks.

Wegovy was first approved by the FDA in 2021 for weight management in adults with obesity or overweight and weight-related medical conditions, alongside a reduced-calorie meal plan and increased physical activity. The indication was expanded in 2022 to include children aged 12 years and older with obesity.

In 2024, Wegovy also received approval to reduce the risk of major cardiovascular events such as death, heart attack, or stroke in adults with known heart disease and either obesity or overweight.