Wegovy Approved for MASH: What the FDA’s New Decision Means
- Jennifer Hardy
- 5 days ago
- 2 min read
The FDA just gave the green light for Wegovy (semaglutide) to treat metabolic-associated steatohepatitis (MASH) in adults with moderate to advanced liver scarring. That makes Wegovy the first GLP-1 approved for this serious liver disease, one that affects nearly 15 million Americans and is only getting more common.
This adds another condition that can be treated with GLP-1s. In fact, Wegovy is now approved for MASH in addition to obesity, overweight with related health risks, and reducing cardiovascular events in people with established heart disease.
What Is MASH?
MASH happens when fat builds up in the liver, triggers inflammation, and leaves scar tissue behind. It’s often tied to conditions like obesity, type 2 diabetes, or high cholesterol.
Many people don’t feel symptoms until the damage is severe, but fatigue, muscle weakness, and unexplained weight loss can be signs. If left untreated, MASH can progress to cirrhosis, liver cancer, or even the need for a transplant.
How Wegovy Helps with MASH
Wegovy promotes weight loss, which helps, but researchers think other mechanisms may also reduce inflammation and fibrosis. The FDA granted this approval through its accelerated pathway, which means Wegovy showed clear improvements in biopsy data. Longer-term results still need to prove that it reduces liver-related deaths, transplants, or hospitalizations.
In an ongoing phase 3 trial with 800 adults, 63 percent of participants on Wegovy saw MASH resolution with no worsening of fibrosis after 72 weeks, compared with 34 percent on placebo.
Another 37 percent had improved fibrosis with no MASH worsening versus 22 percent on placebo. The study runs for 240 weeks, so the big-picture outcomes are still to come.
Safety and precautions
The side effects list looks familiar, falling in line with other things to watch out for when taking semaglutide.
Nausea
Diarrhea
Vomiting
Constipation
Stomach pain
Fatigue
Headache
Anyone with a personal or family history of medullary thyroid cancer, multiple endocrine neoplasia type 2, or an allergy to semaglutide should not take Wegovy.
Why this approval matters
Until now, MASH treatment options have been extremely limited. With Wegovy approved for MASH, obesity, and cardiovascular risk reduction, Novo Nordisk just added another major win to its portfolio. But the story isn’t finished. This accelerated approval hinges on proving Wegovy doesn’t just clean up biopsies. It also saves lives.
Tirzepatide is also looking like a serious contender in the MASH space. Its phase II data show substantial histological improvements that outpace placebo, and it's gaining attention from both the medical community and investors.
It'll be key to see how it fares in longer and larger studies, but right now the signal is clear: MASH could well become part of its approved uses down the road.
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