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

Prior treatment

• 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:
  • Liposuction and/or abdominoplasty, if performed more than 1 year before screening.
  • Laparoscopic gastric banding, if the band was removed more than 1 year before baseline liver biopsy and screening.
  • Intragastric balloon placement, if the balloon was removed more than 1 year before baseline liver biopsy and screening.
  • 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.
• 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.

Other illness

• 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.
• Any health disorder that, in the investigator's opinion, could jeopardize patient safety or affect compliance with the protocol requirements.

Lab values

• 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.
• 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.

Other

• Any contraindication to the appointment of semaglutide.
• MELD score \> 12 points at screening.
• Presence of chronic pancreatitis currently or in history.

• 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.