MAFLDNCT06983171
Semaglutide Effectiveness in Patients With Metabolic Dysfunction-Associated Fatty Liver Disease in the Real World Practice
An observational study of MAFLD, run by Center of target therapy at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- MAFLD
- How many people
- 70 participants
- Where
- 1 siteRussia
- Study dates
- 2 Apr 2025to 12 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-World Clinical Practice Study on the Effectiveness of Semaglutide Over 154 Weeks in Patients With Metabolic Dysfunction-Associated Fatty Liver Disease
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.
Read the 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 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.
- Why is this study important? MAFLD affects 24% of adults globally, with 20% progressing to advanced stages (MASH/cirrhosis).
MAFLD increases risks of liver failure, cardiovascular disease, and is a leading cause for liver transplants.
- Semaglutide may help by: Reducing liver fat and inflammation. Improving weight, blood sugar, and cholesterol. Slowing liver fibrosis progression.
- Study Details Participants: 70 adults with MAFLD and liver fibrosis (stages 0-4).
- Treatment: Semaglutide (target dose is 2.4 mg/week; however, the dose may be lower in case of poor tolerance or safety concerns).
- Duration: 154 weeks.
- Assessments:
Liver biopsies (to measure inflammation/fibrosis). MRI and elastography (non-invasive liver fat/stiffness tests). Blood tests (liver enzymes, cholesterol, HbA1c). Weight and cardiovascular health monitoring.
- Patient Participation Patients will attend the clinic per the routine clinical practice (it is anticipated that there will be approx. 10 visits over 3 years, with phone check-ins between visits).
Treatment will be conducted in accordance with the local label and routine clinical practice.
- Potential Benefits Access to a promising therapy for MAFLD. Close monitoring of liver and metabolic health. Contribution to advancing MAFLD treatment options.
- Risks and Considerations Semaglutide may cause nausea, diarrhea, or other side effects (typically mild). Liver biopsy carries minimal risks (e.g., pain, bleeding).
- Conditions
- MAFLD
- Keywords
- CTT-003, Semaglutide in MAFLD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 154 weeks
Secondary outcomes (5)
Evaluate the impact of semaglutide therapy on patients' body weight
Change in percentage of patients' body weight at the end of treatment relative to the baseline value
Measured: 154 weeks
Evaluate the impact of semaglutide therapy on changes in aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels
Change in ALT and AST activity (measured in U/L) at the end of treatment relative to the baseline value
Measured: 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
Сhanges in Total Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein (HDL) Cholesterol and Triglycerides levels (in mmol/L) at the end of treatment in comparisson with the baseline values
Measured: 154 weeks
Evaluate the impact of semaglutide therapy on changes in High-sensitivity C-reactive Protein (hs-CRP) level
Сhanges in High-sensitivity C-reactive Protein (hs-CRP) level (in mg/L) at the end of treatment in comparisson with the baseline values
Measured: 154 weeks
Evaluate the time to the first cardiovascular event during semaglutide therapy
Time to first serious cardiac and hepatic event in days from the start of treatment
Measured: 154 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start2 Apr 2025
- Primary completion12 Sep 2028 (estimated)
- Study completion12 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MAFLDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center of target therapy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pavel Bogomolov, Prof., PhD, MD, Principal investigator, Center of target therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983171
- Sponsor's protocol ID
- CTT-003
- Status last verified
- May 2025
- First submitted
- 22 Apr 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Clinical Practice Study on the Effectiveness of Semaglutide Over 154 Weeks in Patients With Metabolic Dysfunction-Associated Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT06983171
- Acronym / sponsor ID
- CTT-003
- Conditions
- MAFLD
- Keywords
- CTT-003, Semaglutide in MAFLD
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Center of target therapyUniversity, hospital or other
- Study start
- 2 Apr 2025 (actual)
- Primary completion
- 12 Sep 2028 (estimated)
- Study completion
- 12 Sep 2028 (estimated)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
- Why is this study important? MAFLD affects 24% of adults globally, with 20% progressing to advanced stages (MASH/cirrhosis).
MAFLD increases risks of liver failure, cardiovascular disease, and is a leading cause for liver transplants.
- Semaglutide may help by: Reducing liver fat and inflammation. Improving weight, blood sugar, and cholesterol. Slowing liver fibrosis progression.
- Study Details Participants: 70 adults with MAFLD and liver fibrosis (stages 0-4).
- Treatment: Semaglutide (target dose is 2.4 mg/week; however, the dose may be lower in case of poor tolerance or safety concerns).
- Duration: 154 weeks.
- Assessments:
Liver biopsies (to measure inflammation/fibrosis). MRI and elastography (non-invasive liver fat/stiffness tests). Blood tests (liver enzymes, cholesterol, HbA1c). Weight and cardiovascular health monitoring.
- Patient Participation Patients will attend the clinic per the routine clinical practice (it is anticipated that there will be approx. 10 visits over 3 years, with phone check-ins between visits).
Treatment will be conducted in accordance with the local label and routine clinical practice.
- Potential Benefits Access to a promising therapy for MAFLD. Close monitoring of liver and metabolic health. Contribution to advancing MAFLD treatment options.
- Risks and Considerations Semaglutide may cause nausea, diarrhea, or other side effects (typically mild). Liver biopsy carries minimal risks (e.g., pain, bleeding).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (22 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate the impact of semaglutide therapy on liver morphological changes based on liver histology using the NAFLD Activity Score (NAS).
Time frame: 154 weeks
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
Evaluate the impact of semaglutide therapy on the degree of steatosis change based on Controlled Attenuation Parameter (CAP score)
Time frame: 154 weeks
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
Evaluate the impact of semaglutide therapy on the degree and distribution of fat infiltration in the liver based on MR spectroscopy data
Time frame: 154 weeks
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
Evaluate the impact of semaglutide therapy on changes in liver elasticity based on elastography data
Time frame: 154 weeks
Change in liver fibrosis stage based on elastography data (kPa) at the end of treatment relative to the baseline value
5 secondary outcomes
Evaluate the impact of semaglutide therapy on patients' body weight
Time frame: 154 weeks
Evaluate the impact of semaglutide therapy on changes in aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels
Time frame: 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
Time frame: 154 weeks
Evaluate the impact of semaglutide therapy on changes in High-sensitivity C-reactive Protein (hs-CRP) level
Time frame: 154 weeks
Evaluate the time to the first cardiovascular event during semaglutide therapy
Time frame: 154 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pavel Bogomolov, Prof., PhD, MD principal investigator
Center of target therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of MAFLD, run by Center of target therapy at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the impact of semaglutide therapy on liver morphological changes based on liver histology using the NAFLD Activity Score (NAS). (time frame: 154 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.