Semaglutida para la enfermedad hepática grasa asociada a disfunción metabólica

Fecha de inicio: 2 de abril de 2025

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.