In August 2025, Wegovy became the first GLP-1 drug approved to treat a form of liver disease. Here's what MASH is, what the ESSENCE trial measured, and what the approval does and doesn't mean.
On August 15, 2025, the FDA granted accelerated approval to Wegovy (semaglutide 2.4 mg) for adults with metabolic dysfunction-associated steatohepatitis (MASH) who have moderate to advanced liver fibrosis but not cirrhosis. It's the first and only GLP-1 receptor agonist approved for this use — a new indication layered onto Wegovy's existing approvals for weight management and cardiovascular risk reduction.
MASH is a progressive fatty liver disease, not just "fat around the liver." Fat buildup triggers inflammation, and over time that inflammation scars the liver tissue (fibrosis). Left untreated, an estimated one in five MASH cases progresses to cirrhosis. It's now a leading cause of cirrhosis in US adults and the second most common reason for liver transplants. Roughly one in 20 US adults has MASH, and about one in three people with obesity or overweight also has it — most without knowing, since early MASH is usually asymptomatic.
ESSENCE is a phase 3 trial that randomized 1,197 adults with biopsy-confirmed MASH and stage F2–F3 fibrosis, 2:1, to weekly semaglutide 2.4 mg or placebo, on top of standard lifestyle care. It's designed to run 240 weeks in two parts. Part 1, read out at week 72, looked at liver biopsy changes — the histologic endpoints that supported this approval. Part 2 continues to week 240 and is checking something different and harder to fake: whether semaglutide actually reduces liver-related clinical events like progression to cirrhosis, not just biopsy scores.
That two-part structure is why this is an accelerated approval rather than a standard one. The FDA accepted the biopsy improvements as a reasonably likely predictor of clinical benefit, but Novo Nordisk still has to confirm real-world outcomes in Part 2, expected to read out around 2029.
Among evaluable participants, 63% on semaglutide had resolution of steatohepatitis with no worsening of fibrosis, vs. 34% on placebo. 37% had fibrosis improvement with no worsening of steatohepatitis, vs. 22% on placebo. 33% hit both endpoints at once, vs. 16% on placebo — and 83.5% of the semaglutide group was still on the full 2.4 mg dose at week 72.
Sources: Sanyal AJ, Newsome PN, Kliers I, et al. Phase 3 Trial of Semaglutide in Metabolic Dysfunction-Associated Steatohepatitis. N Engl J Med. 2025;392(21):2089–2099 · Novo Nordisk FDA approval announcement, Aug 15, 2025.
This is not a new weight-loss claim — it's a separate indication for a specific, biopsy-diagnosed liver condition, layered on top of Wegovy's existing uses. Semaglutide isn't prescribed for MASH just because someone is losing weight on it; MASH requires its own diagnosis, typically involving imaging or biopsy.
"Accelerated approval" is a real caveat, not fine print. The FDA is acting on biopsy surrogates while the trial keeps running to confirm the drug actually prevents the outcomes that matter — cirrhosis, liver cancer, transplant. Regulators can withdraw an accelerated approval if the confirmatory data doesn't hold up.
The side effect profile for the MASH indication is the same as Wegovy's existing safety label: GI symptoms, pancreatitis and gallbladder risk, and the standard warnings around thyroid C-cell tumors seen in rodent studies. None of that changes because the indication did.
This article summarizes a published FDA approval and peer-reviewed trial data for general education. It is not medical advice, does not diagnose MASH, and does not replace evaluation by a physician. Only a prescriber can determine whether semaglutide is appropriate for a liver condition.