Active, not recruitingNot applicableObservational
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 70 Years
SexAll
Healthy volunteersNot accepted
ConditionMAFLD
Full registry criteria
Inclusion Criteria: * Informed consent obtained before performing any research-related action. Research-related procedures include any procedures conducted within the framework of this study, including activities to assess eligibility criteria for participation in the study. * Body Mass Index (BMI) \> 30 kg/m². * CAP test result \> 238 dB/m based on steatometry performed no later than 3 months before the patient is included in the study. * Age 18-70 years at the time of signing the informed consent. Exclusion Criteria: * Any contraindication to the appointment of semaglutide. * Documented reasons for chronic liver disease other than non-alcoholic fatty liver disease (NAFLD). * Positive test result for HBsAg, HIV antibodies, or positive test result for HCV-RNA. * Presence of ascites, bleeding from esophageal varices, hepatic encephalopathy, spontaneous bacterial peritonitis, or liver transplantation at the time of screening or a history of these conditions. * ALT activity \> 5 times the upper limit of normal (ULN). * AST activity \> 5 times the ULN. * Alkaline phosphatase activity \> 2 times the ULN at screening. * International Normalized Ratio (INR) of prothrombin time ≥ 1.35 at screening. * MELD score \> 12 points at screening. * Platelet count less than 150,000 per microliter of blood, unless it reflects the patient's usual platelet level, and the patient does not have a diagnosis of portal hypertension in the investigator's opinion. * Treatment with GLP-1 receptor agonists within 90 days prior to the screening visit. * Treatment with hypolipidemic drugs or weight loss medications, whose dosage has not been stable, in the investigator's opinion, for 90 days prior to the screening visit. * Previous or planned (during the study period) treatment of obesity with surgical intervention or the installation of a special device for weight loss. However, the following procedures are allowed: 1. Liposuction and/or abdominoplasty, if performed more than 1 year before screening. 2. Laparoscopic gastric banding, if the band was removed more than 1 year before baseline liver biopsy and screening. 3. Intragastric balloon placement, if the balloon was removed more than 1 year before baseline liver biopsy and screening. 4. Duodenojejunal sleeve bypass, if the sleeve was removed more than 1 year before baseline liver biopsy and screening. * Presence of malignant neoplasms currently or in history within the last 5 years prior to screening. Exceptions include only basal cell or squamous cell skin cancer and any carcinoma in situ. * History of acute pancreatitis within 180 days prior to inclusion in the study. * Presence of chronic pancreatitis currently or in history. * Any of the following: myocardial infarction, stroke, heart failure of NYHA class IV, hospitalization for unstable angina, or transient ischemic attack within the last 90 days before the screening day. * Any health disorder that, in the investigator's opinion, could jeopardize patient safety or affect compliance with the protocol requirements.
Primary outcomes
Evaluate the impact of semaglutide therapy on liver morphological changes based on liver histology using the NAFLD Activity Score (NAS).154 weeksTo 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
Evaluate the impact of semaglutide therapy on the degree of steatosis change based on Controlled Attenuation Parameter (CAP score)154 weeksEvaluate the degree of liver steatosis change based on the CAP test in dB/m at the end of treatment relative to the baseline value
Evaluate the impact of semaglutide therapy on the degree and distribution of fat infiltration in the liver based on MR spectroscopy data154 weeksChange in the quantitative data on the content and distribution of fat in the liver at the end of treatment relative to the baseline value
Evaluate the impact of semaglutide therapy on changes in liver elasticity based on elastography data154 weeksChange in liver fibrosis stage based on elastography data (kPa) at the end of treatment relative to the baseline value