LOS ANGELES, October 14 — On this date, the U.S. Food and Drug Administration granted approval to two drugs, Resmetirom and semaglutide, for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis. This marks a significant step forward for patients facing a progressive liver condition that can lead to cirrhosis, liver failure, and liver cancer if left untreated.
MASH represents a more severe form of metabolic dysfunction-associated steatotic liver disease (MASLD), where fat accumulation in the liver is accompanied by inflammation and liver cell injury. The approvals come after years of research into therapies targeting the underlying metabolic drivers of liver disease.
Resmetirom works by selectively activating thyroid hormone receptors in the liver to reduce fat buildup and inflammation, while semaglutide, a GLP-1 receptor agonist originally developed for diabetes and obesity, helps regulate blood sugar and weight, thereby reducing metabolic stress on the liver. UCLA Health liver specialists, working alongside cardiologists and nutrition experts, have developed a clinical algorithm to guide treatment decisions between these two options.
The tool considers a patient’s full health profile — including coexisting conditions like type 2 diabetes, high cholesterol, and cardiovascular risk — as well as individual preferences and tolerance for side effects. MASLD, the broader condition that precedes MASH, is diagnosed when hepatic steatosis occurs alongside at least one metabolic risk factor such as obesity, insulin resistance, or dyslipidemia.
It is estimated to affect a substantial portion of the U.S. adult population, with progression to MASH carrying increased risk of liver-related morbidity and mortality. Historically, management of MASLD and MASH relied heavily on lifestyle interventions like weight loss through diet and exercise, with bariatric surgery considered in severe cases. Prior to 2024, no FDA-approved pharmacological therapies existed specifically for MASH, making the recent approvals a pivotal shift in clinical care.
The European Union granted approval to Resmetirom in August 2025, following its U.S. clearance earlier that year, highlighting growing international recognition of the need for targeted therapies in metabolic liver disease. These developments reflect a broader trend toward precision medicine in hepatology, where treatment is tailored to the underlying pathophysiology rather than symptoms alone. As research continues, experts emphasize that medication works best when combined with sustained lifestyle changes.
Ongoing studies are exploring long-term outcomes, combination therapies, and strategies to identify patients most likely to benefit from early intervention. Consult your doctor for medical advice.
