FDA approves Wegovy for treatment of MASH in adults with liver fibrosis
Ella Day | August 22, 2025 | News story | Medical Communications, Research and Development | Hepatology, Novo Nordisk, US Food and Drug Administration, clinical trial, hepatitis, obesity
The US Food and Drug Administration (FDA) has granted accelerated approval for Wegovy (semaglutide) as a treatment for adults with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis, but without cirrhosis.
The decision is based on part one of the phase 3 ESSENCE trial, which assessed semaglutide in 800 patients with MASH. Results showed that after 72 weeks, 36.8% of those receiving semaglutide achieved improvement in liver scarring with no worsening of inflammation, compared with 22.4% on placebo. In addition, 62.9% of patients on semaglutide had resolution of liver inflammation with no worsening of fibrosis, compared with 34.3% on placebo.
MASH is a progressive liver disease linked to obesity and metabolic dysfunction. It is estimated to affect more than 250m people globally, with numbers expected to rise significantly by 2030. When untreated, the disease can lead to advanced liver damage, including cancer.
The approval “complements the already proven weight loss, cardiovascular benefits and extensive body of evidence linked to semaglutide,” said Martin Holst Lange, chief scientific officer at Novo Nordisk.
The ESSENCE trial will continue into a second phase, with results expected in 2029, to determine whether semaglutide lowers the risk of liver-related complications in the longer term.
Ella Day
22/8/25
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