On Aug. 15, 2025, Novo Nordisk announced that the US Food and Drug Administration (FDA) has approved a new indication for Wegovy^® (semaglutide) injection 2.4 mg, making it the first and only glucagon-like peptide-1 receptor agonist (GLP-1 RA) FDA-approved to treat adults with MASH with moderate to advanced liver scarring (fibrosis), but not with cirrhosis of the liver, in conjunction with a reduced calorie diet and increased physical activity. This indication is approved based on improvement of MASH and liver scarring (fibrosis). There is an ongoing study to confirm the clinical benefit of Wegovy^® in adults with MASH.

This FDA approval is based on results from the phase 3 ESSENCE trial investigating the effects of once-weekly Wegovy^® 2.4 mg injection on liver histology in adults with MASH and moderate to advanced liver fibrosis (stage F2 to F3) at Week 72. The first primary endpoint showed 63% of people treated with Wegovy^® 2.4 mg injection (n=534) achieved resolution of steatohepatitis and no worsening of liver fibrosis compared to 34% on placebo (n=266) with a statistically significant difference in response rate vs placebo of 29 (95% CI, 21;36).

Additionally, the second primary endpoint showed 37% of people treated with Wegovy^® 2.4 mg achieved improvement in liver fibrosis and no worsening of steatohepatitis compared to 22% on placebo with a statistically significant difference in response rate vs placebo of 14 (95% CI, 8;21). A confirmatory secondary endpoint at Week 72 showed 33% of patients treated with Wegovy^® 2.4 mg achieved both resolution of steatohepatitis and improvement in liver fibrosis compared to 16% on placebo with a statistically significant difference in response rate vs placebo of 17 (95% CI, 10;23). A total of 83.5% of the patients in the semaglutide group maintained the target dose of 2.4 mg until Week 72.

MASH represents a significant health burden in the US, affecting approximately one in 20 people. People living with MASH are often asymptomatic or present with nonspecific symptoms in the early stages of the disease, which may result in a delayed diagnosis. Left untreated, MASH can progress to serious and even fatal outcomes, such as cirrhosis, liver cancer, and the need for liver transplant. Among people who are living with overweight or obesity worldwide, one in three also have MASH.

The FDA initially approved Wegovy^® in 2021 with a reduced calorie meal plan and increased physical activity to help adults with obesity, or some adults with excess weight (overweight) who also have weight-related medical problems to lose weight and keep the weight off. The indication was expanded in 2022 to include children aged 12 years and older with obesity. In 2024, Wegovy^® was approved 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. Today, the FDA has granted accelerated approval for Wegovy^® for a new patient population to treat adults with MASH with moderate to advanced liver scarring (fibrosis), but not with cirrhosis of the liver.