NCT06983171

Semaglutide Effectiveness in Patients With Metabolic Dysfunction-Associated Fatty Liver Disease in the Real World Practice

Real-World Clinical Practice Study on the Effectiveness of Semaglutide Over 154 Weeks in Patients With Metabolic Dysfunction-Associated Fatty Liver Disease

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 70 (estimated)
• Sponsor: Center of target therapy · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This real-world clinical trial evaluates the effectiveness of semaglutide (target dose is 2.4 mg/week) over 154 weeks (3 years) prescribed to the patients with metabolic dysfunction-associated fatty liver disease (MAFLD) and liver fibrosis (stages 0-4) as a part of routine clinical practice. MAFLD is a common liver condition linked to obesity, type 2 diabetes (T2DM), and metabolic syndrome, which can progress to severe liver damage (cirrhosis) and heart disease. Currently, there are no approved medications for MAFLD, and treatment relies on lifestyle changes. Semaglutide, a GLP-1 receptor agonist, has shown promise in improving liver health and metabolic markers in earlier studies.

Detailed description

\- What is this study about? This real-world clinical trial evaluates the effectiveness of semaglutide (in target dose of 2.4 mg/week) over 154 weeks (3 years) prescribed to the patients with metabolic dysfunction-associated fatty liver disease (MAFLD) and liver fibrosis (stages 0-4) as a part of routine clinical practice.. MAFLD is a common liver condition linked to obesity, type 2 diabetes (T2DM), and metabolic syndrome, which can progress to severe liver damage (cirrhosis) and heart disease. Currently, there are no approved medications for MAFLD, and treatment relies on lifestyle changes. Semaglutide, a GLP-1 receptor agonist, has shown promise in improving liver health and metabolic markers in earlier studies. \- Why is this study important? MAFLD affects 24% of adults globally, with 20% progressing to advanced stages (MASH/cirrhosis). MAFLD increases risks of liver failure, cardiovascular disease, and is a leading cause for liver transplants. \- Semaglutide may help by: Reducing liver fat and inflammation. Improving weight, blood sugar, and cholesterol. Slowing liver fibrosis progression. * Study Details Participants: 70 adults with MAFLD and liver fibrosis (stages 0-4). * Treatment: Semaglutide (target dose is 2.4 mg/week; however, the dose may be lower in case of poor tolerance or safety concerns). * Duration: 154 weeks. * Assessments: Liver biopsies (to measure inflammation/fibrosis). MRI and elastography (non-invasive liver fat/stiffness tests). Blood tests (liver enzymes, cholesterol, HbA1c). Weight and cardiovascular health monitoring. \- Patient Participation Patients will attend the clinic per the routine clinical practice (it is anticipated that there will be approx. 10 visits over 3 years, with phone check-ins between visits). Treatment will be conducted in accordance with the local label and routine clinical practice. * Potential Benefits Access to a promising therapy for MAFLD. Close monitoring of liver and metabolic health. Contribution to advancing MAFLD treatment options. * Risks and Considerations Semaglutide may cause nausea, diarrhea, or other side effects (typically mild). Liver biopsy carries minimal risks (e.g., pain, bleeding).

Conditions

• MAFLD

Timeline

• Start date: 2025-04-02
• Primary completion: 2028-09-12
• Completion: 2028-09-12
• First posted: 2025-05-21
• Last updated: 2025-12-22

Locations

1 site across 1 country: Russia