Status:
ACTIVE_NOT_RECRUITING
Semaglutide Effectiveness in Patients With Metabolic Dysfunction-Associated Fatty Liver Disease in the Real World Practice
Lead Sponsor:
Center of target therapy
Conditions:
MAFLD
Eligibility:
All Genders
18-70 years
Brief 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 l...
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 metabol...
Eligibility Criteria
Inclusion
- 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
- 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:
- 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.
- 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.
Key Trial Info
Start Date :
April 2 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 12 2028
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06983171
Start Date
April 2 2025
End Date
September 12 2028
Last Update
December 22 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Center of Target Therapy LLC.
Moscow, Russia, 125008