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

NCT06983171 | Active Not Recruiting

• 1 other identifier: CTT-003
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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 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.

Conditions

MAFLD

Keywords

CTT-003; Semaglutide in MAFLD

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  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

  154 weeks

Secondary Outcomes (5)

• Evaluate the impact of semaglutide therapy on patients' body weight

  154 weeks

• Evaluate the impact of semaglutide therapy on changes in aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels

  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

  154 weeks

• Evaluate the impact of semaglutide therapy on changes in High-sensitivity C-reactive Protein (hs-CRP) level

  154 weeks

• Evaluate the time to the first cardiovascular event during semaglutide therapy

  154 weeks

Study Arms (1)

MAFLD patients

* Body mass index (BMI) \>30 kg/m². * CAP score \>238 dB/m (measured by steatometry no more than 3 months before study enrollment). * Age 18-70 years at the time of signing informed consent.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will enroll adults aged 18-70 years with obesity (BMI \>30 kg/m²) and hepatic steatosis (CAP \>238 dB/m) confirmed within 3 months. Eligible participants must have metabolic dysfunction-associated fatty liver disease (MAFLD) without other chronic liver conditions (e.g., viral hepatitis, cirrhosis complications like ascites, or MELD score \>12).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Center of target therapy: lead

Study Sites (1)

Center of Target Therapy LLC.

Moscow, 125008, Russia

Location

Study Officials

• Pavel Bogomolov, Prof., PhD, MD

  Center of target therapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: May 21, 2025
• Study Start: April 2, 2025
• Primary Completion (Estimated): September 12, 2028
• Study Completion (Estimated): September 12, 2028
• Last Updated: December 22, 2025

Record last verified: 2025-05

Locations

RU (1)