The Food and Drug Administration has granted accelerated approval for Wegovy, a widely prescribed weight-loss drug, to treat adults with metabolic-associated steatohepatitis (MASH – formerly referred to as NASH), a serious liver disease affecting nearly 15 million Americans – and even more people worldwide.
The decision marks the second therapy approved by the FDA for patients with this type of disease, especially those with moderate to advanced fibrosis, a stage of disease in which scar tissue has already formed in the liver. The first, approved in early 2024, is Rezdiffra.
MASH, formerly known as nonalcoholic steatohepatitis (NASH), develops when excess fat in the liver triggers inflammation and scarring. The condition is strongly linked to obesity, type 2 diabetes, high cholesterol, and other metabolic disorders.
Left untreated, it can progress to cirrhosis, liver cancer, or liver failure, often requiring transplantation. An estimated 6 percent of U.S. adults are living with the disease, many without noticeable symptoms until it has advanced.
Clinical Trial Evidence
The approval is based on interim results from a large, late-stage clinical trial known as ESSENCE, which is following patients for nearly five years.
After 72 weeks, 63 percent of patients who received semaglutide, the active ingredient in Wegovy, showed resolution of steatohepatitis without worsening of fibrosis, compared with 34 percent who received a placebo.
In addition, 37 percent of patients taking Wegovy saw improvement in liver scarring with no worsening of the disease, compared with 22 percent on placebo.
Patients receiving Wegovy also lost an average of 10.5 percent of their body weight, a secondary benefit that researchers believe may contribute to improved liver health.
The trial will continue through 240 weeks to determine whether these benefits reduce the risk of death, liver transplantation, or other severe complications. Continued approval for the MASH indication is contingent on confirmation of these longer-term outcomes.
Broader Use of Wegovy
First approved in 2017, Wegovy is already widely used for weight management and to reduce the risk of major cardiovascular events in patients with obesity or overweight.
The new authorization expands its potential market substantially, as obesity and related conditions drive rising rates of liver disease.
“For far too long, this disease has remained unrecognized, undiagnosed, and often untreated, despite impacting so many people,” Dave Moore, executive vice president of U.S. operations at Novo Nordisk, said in a statement. “The FDA’s approval of Wegovy for MASH marks a pivotal milestone and a significant step forward for patients seeking new options.”
Safety Considerations
Wegovy’s safety profile in liver patients is consistent with its other uses. Common side effects include nausea, vomiting, diarrhea, constipation, abdominal pain, and fatigue.
The drug is not recommended for people with a personal or family history of medullary thyroid cancer or certain rare endocrine conditions. And, of course, this can only be used based on a professional’s recommendation.
A Growing Public Health Concern
The FDA’s decision comes as public health officials warn of the rising burden of fatty liver disease in the United States, fueled by obesity and diabetes rates. Because symptoms often emerge only after irreversible damage has occurred, many patients remain undiagnosed until their disease is advanced.
Experts say Wegovy’s approval offers hope for slowing progression in millions of cases. But they caution that it is not a cure, and lifestyle changes such as diet and exercise remain critical to management.
For this, you have the Fatty Liver Diary website, where I share my story of healing fatty liver disease naturally, without medication. I suggest checking out my recommended diet as a starting point, or this in-depth guide on what to do after being diagnosed.
I also published From Fatty Liver to Healthy Liver, the book covering my experience reversing fatty liver disease and everything I did to achieve this.
The FDA’s announcement and further details on the approval are available on the agency’s website here.
I was diagnosed with fatty liver in 2014 and successfully reversed it by mid-2015 using a natural diet and lifestyle changes. Since then, I’ve dedicated over a decade to researching this condition and helping others navigate their own recovery. I am the author of ‘From Fatty Liver to Healthy Liver’ and the founder of this community. My goal is to translate complex medical studies into practical, real-world advice that actually works, combined with my personal experience on the matter.
Can Wegovy be used with early cirrhosis?
The official statement says it was approved for MASH only.