Semaglutide, the active ingredient in Novo Nordisk's Ozempic and Wegovy, cleared advanced fatty liver disease in about 63% of patients after 72 weeks of treatment.
That is compared with 34% on placebo, according to the Phase 3 ESSENCE trial published in the New England Journal of Medicine.
The trial also showed a direct benefit on liver scarring itself. Roughly 37% of patients on the once-weekly 2.4 mg injection saw their liver fibrosis improve without their steatohepatitis getting worse, versus about 22% on placebo.
Those findings pushed the US Food and Drug Administration to grant an accelerated approval on August 15, 2025 for the Wegovy formulation of semaglutide in adults with metabolic dysfunction-associated steatohepatitis, or MASH.
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What MASH actually is
MASH is the aggressive form of fatty liver disease. Fat builds up in the liver, triggers inflammation, and gradually leaves behind scar tissue known as fibrosis.
If it keeps progressing, the liver stiffens into cirrhosis and can eventually fail.
The condition is closely tied to obesity and type 2 diabetes. Novo Nordisk estimates roughly 22 million adults in the United States are affected, and a peer-reviewed modeling study published in JAMA Network Open projects about 14.9 million US adults had MASH in 2020, rising toward 23 million by 2050.
Most people do not know they have it. That is one reason subtle warning signs of fatty liver disease often go unnoticed until a routine blood test or imaging picks up a problem.
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What the trial found
ESSENCE randomized 1,197 adults with biopsy-confirmed MASH and moderate to advanced fibrosis (stages F2 or F3) in a 2:1 ratio to weekly semaglutide 2.4 mg or placebo.
Researchers analyzed liver biopsies from the first 800 patients at week 72.
The results reported by Healio show semaglutide beat placebo on both primary endpoints: 62.9% versus 34.3% for MASH resolution without worsening fibrosis, and 36.8% versus 22.4% for fibrosis improvement without worsening MASH.
Patients on semaglutide also lost about 10.5% of their body weight, compared with 2% on placebo.
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Side effects were mostly gastrointestinal and consistent with what Ozempic and Wegovy users typically report.
Nausea affected 36.3% of those on semaglutide versus 13.2% on placebo, with higher rates of diarrhea, constipation, and vomiting as well.
The first GLP-1 approved for the liver
Before Wegovy's approval, treatment options for MASH were extremely limited.
The FDA had approved only one drug, resmetirom (Rezdiffra), specifically for the condition. Wegovy is now the first GLP-1 receptor agonist cleared for MASH, though the approval carves out patients who have already progressed to cirrhosis.
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The FDA label covers adults with noncirrhotic MASH and F2 to F3 fibrosis, alongside a reduced calorie diet and more physical activity.
A second phase of the ESSENCE trial is ongoing and will follow patients for 240 weeks to see whether semaglutide also reduces liver-related events such as cirrhosis and liver failure.
Anyone worried about fatty liver disease or considering GLP-1 treatment should talk with their doctor about whether they meet the criteria, which typically involves a liver biopsy or specialized imaging to confirm the stage of scarring.
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This article is made and published by Mie Hermansen, who may have used AI in the preparation.