An observational study in Metabolic Dysfunction-Associated Steatotic Liver Disease, sponsored by Kazakh Association of Internal Medicine Specialists. Recruiting at 7 sites in Kazakhstan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Kazakh Association of Internal Medicine Specialists · Observational
This study will look at the health characteristics of adults with metabolic dysfunction-associated steatotic liver disease (MASLD) in Kazakhstan. Researchers want to better understand how this liver condition appears in people in Kazakhstan and how it is managed in everyday medical care.
About 420 adults with MASLD will take part. Researchers will collect information from their medical records, laboratory tests, liver imaging, and questionnaires.
A smaller group of about 65 participants in Almaty who were already prescribed Ursosan® by their doctor before joining the study will be followed for 6 months. Researchers will look at changes in a liver enzyme called alanine aminotransferase (ALT) and other measures of liver health. The study does not assign Ursosan® or any other treatment. Treatment decisions are made by each participant's doctor as part of their usual medical care.
The results may help researchers better understand MASLD in Kazakhstan and how people with MASLD respond to Ursosan® when it is used in everyday medical care.
This is a post-marketing, non-interventional observational study with two components: a cross-sectional component and a prospective cohort component. The study is designed to describe the clinical profile of adults with metabolic dysfunction-associated steatotic liver disease (MASLD) in Kazakhstan and to assess the real-world clinical effectiveness of ursodeoxycholic acid (Ursosan®) in a subgroup of participants in Almaty.
In the cross-sectional component, clinical information collected during routine medical care will be used to characterize MASLD, including liver disease severity, metabolic risk factors, laboratory findings, current treatment, and lifestyle-related factors. Data for this component are collected once for each participant.
The prospective cohort component includes participants in Almaty who had already been prescribed Ursosan® by their treating physician as part of routine clinical practice before enrollment. These participants will be followed for approximately 6 months. Follow-up includes remote contacts at approximately 2 and 4 months and a final assessment at approximately 6 months.
The study does not assign treatment or require treatment decisions to be made according to the study protocol. The decision to prescribe Ursosan®, as well as other diagnostic and treatment decisions, is made independently by the treating physician as part of routine medical care.
Kazakh Association of Internal Medicine Specialists is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults aged 18 to 65 years with confirmed metabolic dysfunction-associated steatotic liver disease (MASLD) who seek medical care at participating study centers in Kazakhstan. A total of approximately 420 participants will be enrolled in the study. Participants have imaging-confirmed hepatic steatosis and at least one cardiometabolic criterion for MASLD. A prospective cohort subgroup of approximately 65 participants in Almaty includes patients with ALT ≥1.5 times the upper limit of normal who had been prescribed Ursosan® (ursodeoxycholic acid) as part of routine clinical practice no more than 4 weeks before enrollment, independently of participation in the study.
Inclusion Criteria:1. Men and women aged 18 to 65 years. 2. Voluntary willingness to provide to participate in the study.
3. Imaging-confirmed hepatic steatosis based on ultrasound, computed tomography (CT), or magnetic resonance imaging (MRI).
4. At least one confirmed criterion of metabolic dysfunction-associated steatotic liver disease (MASLD), according to the EASL 2024 diagnostic criteria, including:
Additional Inclusion Criteria for the Prospective Cohort Subgroup:
Exclusion Criteria: 1. Drug-induced liver injury, including long-term treatment with glucocorticosteroids, tamoxifen, amiodarone, irinotecan, methotrexate, lomitapide, valproate, or 5-fluorouracil.
2. Wilson disease, hypobetalipoproteinemia, lysosomal acid lipase deficiency, celiac disease, hemochromatosis, or cryptogenic hepatic steatosis, based on medical history.
3. liver diseases, including primary biliary cholangitis (PBC), autoimmune hepatitis (AIH), primary sclerosing cholangitis (PSC), etc., based on medical history.
4. Lipodystrophy, based on medical history. 5. Endocrine disorders, including growth hormone deficiency and primary or secondary panhypopituitarism, based on medical history.
6. Nutritional deficiency or malnutrition. 7. Parenteral nutrition. 8. Bariatric surgery. 9. Anorexia. 10. Pregnancy. 11. Polycystic ovary syndrome. 12. Type 1 diabetes mellitus. 13. Hypothyroidism. 14. Chronic dialysis. 15. Active at the time of study enrollment. 16. Signs of psychiatric disorders. 17. Inability to comply with the study protocol or any other reason that, in the investigator's opinion, may prevent successful participation in the study.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults with confirmed metabolic dysfunction-associated steatotic liver disease (MASLD) enrolled in the cross-sectional component of the study. Clinical, laboratory, imaging, treatment, and lifestyle-related data obtained during routine medical care are collected once for each participant. No treatment or other intervention is assigned by the study protocol. This population includes participants who may also meet the criteria for the prospective Ursosan® cohort.
A subgroup of participants in Almaty with MASLD who were already receiving Ursosan® (ursodeoxycholic acid) prescribed by their treating physician as part of routine clinical practice before study enrollment and independently of study participation. These participants are followed prospectively for 6 months, with remote contacts at approximately 2 and 4 months and a final follow-up assessment at approximately 6 months. The study does not assign Ursosan® treatment; treatment decisions remain under the responsibility of the treating physician.
Proportion of Participants With Hepatic Steatosis According to Imaging
Proportion of participants with MASLD who have hepatic steatosis according to available imaging results.
Time frame: 1 to 7 days
Proportion of Participants With Liver Fibrosis According to FibroScan
Proportion of participants with MASLD who have liver fibrosis according to FibroScan results.
Time frame: 1 to 7 days
Proportion of Participants With Liver Cirrhosis According to FibroScan
Proportion of participants with MASLD who have liver cirrhosis according to FibroScan results.
Time frame: 1 to 7 days
Proportion of Participants With at Least 30% Reduction in ALT From Baseline
Proportion of participants in the prospective cohort with a decrease in alanine aminotransferase (ALT) of at least 30% from the baseline value at approximately 6 months.
Time frame: 6 months ± 2 weeks
Proportion of Participants With Abnormal Laboratory Parameters
Proportion of participants with abnormalities in red blood cell count, hemoglobin, leukocytes, platelets, ALT, AST, GGT, bilirubin fractions, alkaline phosphatase, total cholesterol, HDL-C, LDL-C, triglycerides, creatinine, glucose, albumin, insulin, INR, and AFP.
Time frame: 1 to 7 days
Proportion of Participants With Cardiometabolic Risk Factors
Proportion of participants with cardiometabolic risk factors, including overweight or obesity; hyperglycemia or type 2 diabetes; triglycerides ≥1.7 mmol/L (≥150 mg/dL) or lipid-lowering treatment; HDL-C ≤1.0 mmol/L (≤39 mg/dL) in men or ≤1.3 mmol/L (≤50 mg/dL) in women or lipid-lowering treatment; and blood pressure ≥130/85 mmHg or treatment for hypertension.
Time frame: 1 to 7 days
Proportion of Participants by Eating Behavior Profile Based on the DEBQ
Proportion of participants with different eating behavior profiles according to the Dutch Eating Behavior Questionnaire (DEBQ).
Time frame: 1 to 7 days
Proportion of Participants by Degree of Alcohol Misuse Based on AUDIT
Proportion of participants with different degrees of alcohol misuse according to the Alcohol Use Disorders Identification Test (AUDIT).
Time frame: 1 to 7 days
Prevalence of Concomitant Diseases in Participants With MASLD
Prevalence of concomitant diseases among participants with MASLD.
Time frame: 1 to 7 days
Prevalence of Medication and Dietary Supplement Use in Participants With MASLD
Prevalence of individual medication classes, active substances, and dietary supplements used as current therapy among participants with MASLD.
Time frame: 1 to 7 days
Proportion of Participants by Liver Fibrosis Risk Category According to FIB-4
Proportion of participants classified into different liver fibrosis risk categories, from low to high risk, according to the FIB-4 index.
Time frame: 1 to 7 days
Proportion of Participants by Cardiovascular Mortality Risk Category According to SCORE
Proportion of participants classified into different cardiovascular mortality risk categories, from low to very high risk, according to the SCORE Risk index.
Time frame: 1 to 7 days
Change in Liver Fibrosis Assessed by FibroScan
Change from baseline in liver stiffness measured in kilopascals (kPa) by FibroScan at approximately 6 months in participants receiving ursodeoxycholic acid (UDCA).
Time frame: 6 months ± 2 weeks
Change in Hepatic Steatosis Assessed by FLI and HSI
Change from baseline in the Fatty Liver Index (FLI) and Hepatic Steatosis Index (HSI) at approximately 6 months in participants receiving UDCA.
Time frame: 6 months ± 2 weeks
Proportion of Participants With Changes in Protocol-Specified Laboratory Parameters From Baseline
Proportion of participants with changes from baseline in platelet count, aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP), and triglycerides at approximately 6 months
Time frame: 6 months ± 2 weeks
Proportion of Participants With Changes in Eating Behavior Assessed by the DEBQ
Proportion of participants receiving UDCA with changes from baseline in eating behavior measures assessed using the Dutch Eating Behavior Questionnaire (DEBQ) at approximately 6 months
Time frame: 6 months ± 2 weeks
Plan to share: No — Individual participant data will not be shared because access to study data is restricted to authorized study personnel and requires sponsor approval. De-identified data may be used for scientific reports, publications, and regulatory submissions in accordance with the study protocol and applicable data protection requirements.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Kazakh Association of Internal Medicine Specialists