Metabolic Dysfunction-Associated Steatotic Liver DiseaseNCT07889999
Clinical Profile of Patients With MASLD in Kazakhstan and Clinical Effectiveness of Ursosan in Almaty
An observational study of Metabolic Dysfunction-Associated Steatotic Liver Disease, run by Kazakh Association of Internal Medicine Specialists at 7 sites in Kazakhstan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Metabolic Dysfunction-Associated Steatotic Liver Disease
- How many people
- 420 participants
- Where
- 7 sitesKazakhstan
- Study dates
- 12 Aug 2026to 12 Aug 2028
- Phase
- Observational
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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 informed consent to participate in the study.
- Imaging-confirmed hepatic steatosis based on ultrasound, computed tomography (CT), or magnetic resonance imaging (MRI).
- At least one confirmed criterion of metabolic dysfunction-associated steatotic liver disease (MASLD), according to the EASL 2024 diagnostic criteria, including:
- Obesity or overweight:
- Body mass index ≥25 kg/m² (≥23 kg/m² in people of Asian ethnicity);
- Waist circumference ≥94 cm in men and ≥80 cm in women of European ethnicity, or ≥90 cm in men and ≥80 cm in women of Asian ethnicity;
- Hyperglycemia or type 2 diabetes mellitus:
- Prediabetes: HbA1c 39-47 mmol/mol (5.7-6.4%), or fasting plasma glucose 5.6-6.9 mmol/L (100-125 mg/dL), or 2-hour plasma glucose during an oral glucose tolerance test 7.8-11.0 mmol/L (140-199 mg/dL); or
- Type 2 diabetes mellitus: HbA1c ≥48 mmol/mol (≥6.5%), or fasting plasma glucose ≥7.0 mmol/L (≥126 mg/dL), or 2-hour plasma glucose during an oral glucose tolerance test ≥11.1 mmol/L (≥200 mg/dL), or treatment for type 2 diabetes mellitus;
- Plasma triglycerides ≥1.7 mmol/L (≥150 mg/dL) or lipid-lowering treatment;
- HDL cholesterol ≤1.0 mmol/L (≤39 mg/dL) in men and ≤1.3 mmol/L (≤50 mg/dL) in women, or lipid-lowering treatment;
- Blood pressure ≥130/85 mmHg or treatment for hypertension.
Additional Inclusion Criteria for the Prospective Cohort Subgroup:
- Participants undergoing evaluation in Almaty.
- ALT level ≥1.5 times the upper limit of normal, with the upper limit of normal defined as 29-33 U/L for men and 19-25 U/L for women.
- Participants receiving Ursosan® therapy prescribed by a physician as part of routine clinical practice no more than 4 weeks before study enrollment, independently of participation in this study.
Exclusion Criteria: 1. Drug-induced liver injury, including long-term treatment with glucocorticosteroids, tamoxifen, amiodarone, irinotecan, methotrexate, lomitapide, valproate, or 5-fluorouracil.
- Wilson disease, hypobetalipoproteinemia, lysosomal acid lipase deficiency, celiac disease, hemochromatosis, or cryptogenic hepatic steatosis, based on medical history.
- Autoimmune liver diseases, including primary biliary cholangitis (PBC), autoimmune hepatitis (AIH), primary sclerosing cholangitis (PSC), etc., based on medical history.
- Lipodystrophy, based on medical history. 5. Endocrine disorders, including growth hormone deficiency and primary or secondary panhypopituitarism, based on medical history.
- 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 malignancy 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Kazakhstan7 sites, 7 recruiting
- Recruiting
Mangystau Regional Multidisciplinary Hospital
Aktau, Mangystau
Polina Muldasheva, Gastroenterologist, +7 701 164 90 65, polinamuldasheva@gmail.com
- Recruiting
Saqta Clinic Llp
Aktau, Mangystau
Roza Atasheva, Gastroenterologist, +7 778 555 14 95, rozochka.95@list.ru
- Recruiting
Medical Center of Marat Ospanov West Kazakhstan Medical University
Aktobe, Aktobe
Dariga Kushimova, Gastroenterologist, +7 775 183 6790, dkushimova@mail.ru
- Recruiting
City Polyclinic No. 5
Almaty, Almaty
Aizhan Muratbekova, Head of the Hepatology Center, +7 747 690 4042, almaty.hep@mail.ru
Aliya Balabek, Gastroenterologist, +7 747 427 66 26, Ali.nur89@inbox.ru
- Recruiting
Research Institute of Cardiology and Internal Diseases
Almaty, Almaty
Almagul Dzhumabayeva, Gastroenterologist, +7 701 512 23 26, almusa010@mail.ru
- Recruiting
National Scientific Medical Center
Astana, Astana
Nina Valeryevna Tostanovskaya, Gastroenterologist, +7 707 812 11 26, nina.tostanovskaya@gmail.com
- Recruiting
Syzdykova Individual Entrepreneur
Shymkent, Shymkent
Tatyana Valeryevna Kassymova, Gastroenterologist, +7 775 226 81 43, kassymovatv@gmail.com
About this study
Official title: Assessment of the Clinical Profile of Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) in the Republic of Kazakhstan and the Clinical Effectiveness of UDCA (Ursosan®) in the Patient Population of Almaty: A Longitudinal Observational Combined Study With Cross-Sectional and Prospective Cohort Components
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.
Read more
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.
Read the detailed description
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.
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 |
|---|---|---|
| Overall MASLD Study Population | 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. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With Hepatic Steatosis According to Imaging
Proportion of participants with MASLD who have hepatic steatosis according to available imaging results.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months ± 2 weeks
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 1 to 7 days
Prevalence of Concomitant Diseases in Participants With MASLD
Prevalence of concomitant diseases among participants with MASLD.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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
Measured: 6 months ± 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start12 Aug 2026
- Primary completion12 Aug 2028 (estimated)
- Study completion12 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-Associated Steatotic Liver DiseaseStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kazakh Association of Internal Medicine Specialists
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Almagul Dzhumabayeva, Gastroenterologist, Principal investigator, Research Institute of Cardiology and Internal Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07889999
- Sponsor's protocol ID
- PRO-MASLD-25
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.