The American Association for the Study of Liver Diseases (AASLD) applauds the U.S. Food and Drug Administration’s (FDA) recent approval of Wegovy®, widely recognized for weight loss and diabetes management, as a new treatment for adults with Metabolic dysfunction-Associated Steatohepatitis (MASH) and moderate to advanced liver fibrosis.
MASH, a subset of Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD), is characterized by fat accumulation in the liver, leading to inflammation and scarring. Risk factors include obesity, type 2 diabetes, high triglycerides, and elevated LDL cholesterol. Despite its growing prevalence, effective treatment options have been limited.
This landmark approval marks a significant advancement in the field of hepatology, as Wegovy is now the first FDA-approved GLP-1 therapy specifically for treating MASH, offering new hope for patients and clinicians alike. The FDA’s decision to approve Wegovy provides clinicians with a long-awaited new therapeutic option for MASH, which according to the FDA, affects about 6% of adults, or nearly 15 million people. The recent FDA approval of Wegovyw for MASH follows last year’s approval of Rezdiffra (resmetirom), the first drug to treat patients with the disease. These milestones signal progress in expanding treatment options for liver disease and keep the hepatology community energized for what’s ahead.
“This approval represents an exciting turning point in how we approach liver disease treatment. It integrates liver health into overall wellness,” said Grace L. Su, MD, FAASLD, President of AASLD. “Wegovy is one of the most widely known and prescribed therapies for obesity and diabetes. This new approval for MASH extends that influence to liver health. As As GLP-1 therapy has reshaped how millions manage their health, this decision ensures liver disease is recognized as part of that process. It gives patients and providers real hope while underscoring the need for continued innovation and equitable access to liver care.”
Research presented at AASLD’s The Liver Meeting® (TLM) in 2024 demonstrated semaglutide’s groundbreaking potential in treating MASH. The Phase 3 ESSENCE trial evaluated adults with MASH and moderate to advanced liver fibrosis, showing that semaglutide significantly improved liver inflammation and fibrosis versus placebo. Among participants, 63% achieved resolution of steatohepatitis without worsening fibrosis, 37% experienced improved fibrosis without worsening steatohepatitis, and one-third saw both outcomes. The study also showed benefits in liver enzymes, non-invasive fibrosis markers, body weight, and cardiometabolic health (source).
“These findings demonstrate how AASLD continues to be at the forefront of hepatology, providing critical research and evidence that helped to inform the FDA’s recent approval,” Dr. Su said.
As the leading organization of scientists and healthcare professionals committed to preventing and curing liver disease, AASLD will continue to collaborate with researchers, clinicians, and stakeholders to advance education, research, and advocacy for liver health worldwide.