From the Guidelines
No, Ozempic (semaglutide) is not FDA-approved for the treatment of fatty liver disease. Ozempic is currently only FDA-approved for the treatment of type 2 diabetes and for chronic weight management in adults with obesity or overweight with at least one weight-related condition. While some research suggests that GLP-1 receptor agonists like semaglutide may have beneficial effects on liver fat content and potentially improve non-alcoholic steatohepatitis (NASH), these are considered off-label uses 1.
Key Points to Consider
- Patients with fatty liver disease should work with healthcare providers to develop appropriate treatment plans, which typically include lifestyle modifications such as weight loss, dietary changes, and increased physical activity as first-line approaches.
- Other medications specifically being studied for fatty liver disease include vitamin E, pioglitazone, and obeticholic acid, though none are yet FDA-approved specifically for NASH.
- The mechanism by which semaglutide might benefit fatty liver involves weight reduction, improved insulin sensitivity, and potentially direct anti-inflammatory effects, but more research is needed before it becomes an approved therapy for this condition.
- Recent guidelines suggest that pioglitazone can be used for NASH patients with diabetes, and vitamin E may be considered in nondiabetic adults with biopsy-proven NASH 1.
- GLP-1 receptor agonists, such as semaglutide, have shown promise in reducing hepatic steatosis in patients with NAFLD, but their role in the treatment of NASH remains to be fully established 1.
Recommendations for Clinical Practice
- Healthcare providers should prioritize lifestyle modifications and optimal management of comorbidities, including the use of incretin-based therapies like semaglutide for type 2 diabetes or obesity, if indicated.
- Bariatric surgery may be considered an option for individuals with MASLD and obesity.
- Management of MASH-related cirrhosis includes adaptations of metabolic drugs, nutritional counseling, surveillance for portal hypertension and HCC, as well as liver transplantation in decompensated cirrhosis 1.
From the Research
Ozempic (Semaglutide) for Fatty Liver Disease
- Ozempic (semaglutide) is not explicitly FDA-approved for the treatment of fatty liver disease, but it has been studied for its potential effects on non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) 2.
- Clinical development for obesity, NAFLD, and NASH is underway worldwide, indicating a potential future approval for these conditions 2.
- A systematic review and meta-analysis found that semaglutide treatment showed a reduction in serum alanine transaminase and aspartate transaminase levels, improvement in liver fat content and liver stiffness, and significant improvements in glycated hemoglobin level and lipid profile in patients with NAFLD/NASH 3.
Current FDA Approval
- Ozempic (semaglutide) is currently FDA-approved for the treatment of type 2 diabetes mellitus 2.
- Other treatments, such as pioglitazone, have been studied for their effectiveness in patients with NAFLD and type 2 diabetes, showing promising results 4.
- Sodium-glucose cotransporter 2-inhibitors (SGLT2-i) have also been studied for their effects on steatosis and fibrosis in patients with NAFLD or NASH and type 2 diabetes, showing improvements in non-invasive markers of steatosis or fibrosis 5.