Introduction to Wegovy and Liver Disease
The weight loss drug Wegovy treated a serious form of liver disease in about two-thirds of patients in a major clinical trial, according to the findings published Wednesday in the New England Journal of Medicine.
Metabolic dysfunction-associated steatotic liver disease — previously known as nonalcoholic fatty liver disease — affects about 33% of adults in the U.S. About 5% to 7% have a more advanced form of the disease, called metabolic dysfunction-associated steatohepatitis, or MASH. (Another type of liver disease, alcohol-associated liver disease, is caused by drinking.)
Understanding Liver Disease
Both conditions are the result of the body storing too much fat in the liver, said Dr. Sobia Laique, a liver doctor and the director of the Multidisciplinary MASLD Clinic at Cleveland Clinic. In people with MASH, the excess fat has started to cause inflammation, which over time can lead to scarring, or fibrosis. Left untreated, it can progress to liver failure and liver cancer, Laique said.
Prevalence of Liver Disease
Metabolic dysfunction-associated steatotic liver disease is more common in people with obesity or Type 2 diabetes, according to the National Institutes of Health. An estimated 75% of overweight people and more than 90% of people with obesity have the disease.
Current Treatment Options
There’s only one FDA-approved medication for MASH, called resmetirom, Laique said. However, the medication only helps about a quarter of patients and doesn’t address the underlying conditions that drive the disease. Bariatric surgery is often the recommended treatment for those who can’t resolve the condition through lifestyle changes, she added.
Clinical Trial Results
The trial, funded by drugmaker Novo Nordisk, included 800 patients with MASH from 37 countries. Patients either got a weekly 2.4 milligram dose of semaglutide, the active ingredient in Ozempic and Wegovy, or a placebo, for 72 weeks. The trial found that about 63% of patients in the semaglutide group saw a reduction in liver inflammation, compared with 34.3% of people who got a placebo.
Benefits of Semaglutide
Prior to starting the trial, the participants also had moderate to high levels of scar tissue in the liver, known as stage 2 or 3 fibrosis. About 37% of the semaglutide group saw improvements in their fibrosis, compared with 22.4% in the placebo group. The semaglutide group also saw other benefits, including a 10.5% average weight loss.
Expert Reaction
Dr. Susan Spratt, an endocrinologist and senior medical director for the Population Health Management Office at Duke Health in North Carolina who was not involved in the study, said she was impressed, noting that once fibrosis has developed in patients, it’s often difficult to reverse or treat the inflammation. Dr. Christopher McGowan, a gastroenterologist who runs a weight loss clinic in Cary, North Carolina, said in an email that the results may offer hope for a condition with few treatment options but added that long-term data is needed to determine whether the improvements from the drug will reduce liver-related complications and death.
Growing List of Conditions Treated by GLP-1s
The trial results add to the growing list of conditions that GLP-1s — the class of drugs that includes Novo Nordisk’s Ozempic and Wegovy and Eli Lilly’s Mounjaro and Zepbound — can treat beyond diabetes and weight loss. Last year, the Food and Drug Administration approved Wegovy to reduce heart disease risk in people with obesity. The agency also approved Zepbound for obstructive sleep apnea in December, and Ozempic to treat chronic kidney disease in patients with Type 2 diabetes in January. Researchers are also investigating whether the drugs are effective against Alzheimer’s and alcohol addiction.
Conclusion
The results of the clinical trial are promising, and the FDA could make a decision on whether to approve Wegovy for MASH as early as the end of the year. While there are still questions about the long-term effectiveness of the drug, the trial results offer hope for a condition with few treatment options.
FAQs
- What is metabolic dysfunction-associated steatotic liver disease?
Metabolic dysfunction-associated steatotic liver disease is a condition where the body stores too much fat in the liver, leading to inflammation and scarring. - What is the current treatment for MASH?
The current treatment for MASH includes one FDA-approved medication, resmetirom, and bariatric surgery for those who can’t resolve the condition through lifestyle changes. - What were the results of the clinical trial?
The clinical trial found that about 63% of patients in the semaglutide group saw a reduction in liver inflammation, compared with 34.3% of people who got a placebo. - What are the potential benefits of semaglutide?
Semaglutide may offer benefits beyond reducing liver inflammation, including improving fibrosis and promoting weight loss. - When could the FDA make a decision on approving Wegovy for MASH?
The FDA could make a decision on whether to approve Wegovy for MASH as early as the end of the year.
