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
Sponsor study identifier
observational
420
1 country
7
Study Start
August 12, 2026
Actual (reported)Primary Completion
August 12, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 12, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 12, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 12, 2026
Actual (reported)October 8, 2026
Actual (reported)October 22, 2026
Actual (reported)August 12, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 12, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Proportion of Participants With Hepatic Steatosis According to Imaging
Proportion of participants with MASLD who have hepatic steatosis according to available imaging results.
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.
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.
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.
6 months ± 2 weeks
Proportion of Participants With Abnormal Laboratory Parameters
1 to 7 days
Proportion of Participants With Cardiometabolic Risk Factors
1 to 7 days
Proportion of Participants by Eating Behavior Profile Based on the DEBQ
1 to 7 days
Proportion of Participants by Degree of Alcohol Misuse Based on AUDIT
1 to 7 days
Prevalence of Concomitant Diseases in Participants With MASLD
1 to 7 days
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.
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.
Medical Center of Marat Ospanov West Kazakhstan Medical University
Aktobe, Aktobe, Kazakhstan
City Polyclinic No. 5
Almaty, Almaty, Kazakhstan
Almagul Dzhumabayeva, Gastroenterologist
Research Institute of Cardiology and Internal Diseases
First Submitted
October 8, 2026
First Posted
October 22, 2026
Study Start
August 12, 2026
Actual (reported)Primary Completion
August 12, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Contact the study team to confirm eligibility.
Research Institute of Cardiology and Internal Diseases
Almaty, Almaty, Kazakhstan
National Scientific Medical Center
Astana, Astana, Kazakhstan
Mangystau Regional Multidisciplinary Hospital
Aktau, Mangystau, Kazakhstan
Saqta Clinic Llp
Aktau, Mangystau, Kazakhstan
Syzdykova Individual Entrepreneur
Shymkent, Shymkent, Kazakhstan
Study Completion
August 12, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 22, 2026
Record last verified: 2026-10
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.
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Source: ClinicalTrials.gov.
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