FDA grants accelerated approval to Wegovy for liver disease MASH

On Aug. 15, 2025, the FDA granted accelerated approval to Wegovy (semaglutide) injection 2.4 mg to treat adults with metabolic dysfunction-associated steatohepatitis, or MASH, who have moderate to advanced liver scarring, but not cirrhosis ^[1][2]. The drug is used along with a reduced-calorie diet and increased physical activity ^[2]. Novo Nordisk, which makes Wegovy, says it is the first GLP-1 receptor agonist approved for this use ^[2].

What the approval covers

MASH, formerly called nonalcoholic steatohepatitis, is a form of fatty liver disease in which fat buildup causes inflammation and scarring ^[1][4]. The FDA says about 6% of US adults, or 14.9 million people, have MASH and that the number is growing ^[1]. Novo Nordisk puts the figure at about 1 in 20 people in the United States ^[2]. Many people have no symptoms until liver damage is severe; symptoms can include fatigue, unexplained weight loss and muscle weakness ^[1].

The new indication covers fibrosis stage F2 to F3, meaning moderate to advanced scarring, and specifically excludes people with cirrhosis ^[2][4]. Wegovy is also approved for obesity and overweight, and to reduce the risk of major cardiovascular events such as heart attack or stroke in adults with known heart disease plus obesity or overweight ^[1][2]. The FDA's announcement says Wegovy was first approved in 2017, while Novo Nordisk says the FDA initially approved Wegovy in 2021; the two accounts differ on that date ^[1][2].

The trial numbers

The accelerated approval rests on Part 1 of the phase 3 ESSENCE trial, which randomized 1,197 adults with MASH and stage F2 or F3 fibrosis 2:1 to semaglutide or placebo, on top of standard care, for 240 weeks ^[2][3][4]. The week-72 interim analysis described by the FDA covered 800 participants: 534 on semaglutide and 266 on placebo ^[1].

At 72 weeks, 63% of participants taking semaglutide had their steatohepatitis resolve with no worsening of liver fibrosis, compared with 34% on placebo, a difference of 29 percentage points (95% CI, 21 to 36) ^[1][2][4]. And 37% of those on semaglutide had improvement in liver fibrosis with no worsening of steatohepatitis, compared with 22% on placebo, a difference of 14 percentage points (95% CI, 8 to 21) ^[1][2][4]. A secondary measure found 33% of people on semaglutide achieved both resolution of steatohepatitis and improvement in fibrosis, compared with 16% on placebo ^[2][4].

One published commentary by hepatologist Rohit Loomba lists the placebo fibrosis-improvement rate as 24% rather than 22%; the FDA, Novo Nordisk and a trade publication all report 22% ^[1][2][3][4]. Novo Nordisk says 83.5% of participants stayed on the target 2.4 mg dose through week 72, while one trade publication reports about 88% ^[2][4].

Safety and the limits of the data

The most common side effects were gastrointestinal, including nausea, diarrhea, vomiting, constipation, abdominal pain, headache and fatigue ^[1]. One report says serious gastrointestinal events occurred in 13.4% of the semaglutide group and led 2.6% of that group and 3.3% of the placebo group to stop the trial early ^[4]. Nine people died during the trial, three in the semaglutide group and six on placebo, with no evident clustering of causes, according to that report ^[4].

Because this is an accelerated approval, it is based on liver biopsy results, a surrogate measure, rather than on whether patients live longer or avoid a transplant ^[1]. The label states the indication is approved based on improvement in MASH and liver scarring and that an ongoing study will confirm the clinical benefit ^[2]. It is not known whether Wegovy is safe or effective for MASH in people under 18 ^[2].

Why it matters for patients

MASH can progress to cirrhosis, liver cancer, liver failure requiring transplant, or death ^[1]. Novo Nordisk says the disease progresses to cirrhosis in an estimated 20% of cases and that MASH-related cirrhosis is the second most common reason for a liver transplant in the US ^[2]. Before this approval, resmetirom (Rezdiffra) was the only approved treatment for MASH with fibrosis ^[3][4].

Several practical points are worth knowing. The change is to the drug's label; Wegovy was already on the market for weight and heart risk, so the approval is not a new product ^[1][2]. Whether health insurers will cover Wegovy specifically for the liver indication has not been reported. Because the approval excludes cirrhosis, specialists writing about it say semaglutide and resmetirom should only be used in stage 2 or 3 disease, and that patients with established cirrhosis still lack approved options ^[3]. The label says not to use Wegovy if you or a family member have had medullary thyroid cancer, if you have multiple endocrine neoplasia syndrome type 2, or if you have had a serious allergic reaction to semaglutide ^[1][2].

"Today's decision by the FDA reflects the continued progress in how we understand and treat patients with MASH, bringing us closer to care that meets the needs of people living with this disease," said Arun Sanyal, MD, director of the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health at Virginia Commonwealth University ^[2][3].

What happens next

Part 2 of the ESSENCE trial runs to 240 weeks and is testing whether semaglutide lowers the risk of liver-related clinical events compared with placebo; results are expected in 2029 ^[2][4]. Novo Nordisk also filed for regulatory approval in the European Union in February 2025 and in Japan in May 2025 ^[2].