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.
\- 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).
Study Type
OBSERVATIONAL
Enrollment
70
Center of Target Therapy LLC.
Moscow, Russia
Evaluate the impact of semaglutide therapy on liver morphological changes based on liver histology using the NAFLD Activity Score (NAS).
To compare change in the degree of steatosis, severity of inflammation, ballooning degeneration, stage of fibrosis NAFLD Activity Score (NAS = 0-8 points) at the end of treatment relative to baseline values
Time frame: 154 weeks
Evaluate the impact of semaglutide therapy on the degree of steatosis change based on Controlled Attenuation Parameter (CAP score)
Evaluate the degree of liver steatosis change based on the CAP test in dB/m at the end of treatment relative to the baseline value
Time frame: 154 weeks
Evaluate the impact of semaglutide therapy on the degree and distribution of fat infiltration in the liver based on MR spectroscopy data
Change in the quantitative data on the content and distribution of fat in the liver at the end of treatment relative to the baseline value
Time frame: 154 weeks
Evaluate the impact of semaglutide therapy on changes in liver elasticity based on elastography data
Change in liver fibrosis stage based on elastography data (kPa) at the end of treatment relative to the baseline value
Time frame: 154 weeks
Evaluate the impact of semaglutide therapy on patients' body weight
Change in percentage of patients' body weight at the end of treatment relative to the baseline value
Time frame: 154 weeks
Evaluate the impact of semaglutide therapy on changes in aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels
Change in ALT and AST activity (measured in U/L) at the end of treatment relative to the baseline value
Time frame: 154 weeks
Evaluate the impact of semaglutide therapy on changes in Total Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein (HDL) Cholesterol and Triglycerides levels
Сhanges in Total Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein (HDL) Cholesterol and Triglycerides levels (in mmol/L) at the end of treatment in comparisson with the baseline values
Time frame: 154 weeks
Evaluate the impact of semaglutide therapy on changes in High-sensitivity C-reactive Protein (hs-CRP) level
Сhanges in High-sensitivity C-reactive Protein (hs-CRP) level (in mg/L) at the end of treatment in comparisson with the baseline values
Time frame: 154 weeks
Evaluate the time to the first cardiovascular event during semaglutide therapy
Time to first serious cardiac and hepatic event in days from the start of treatment
Time frame: 154 weeks
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