Health profile of MASLD in Kazakhstan and real-world use of Ursosan in Almaty

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a non-interventional observational study with two components: a cross-sectional description of MASLD characteristics in adults across Kazakhstan and a prospective cohort of about 65 patients in Almaty who were already taking Ursosan. Data will be collected from medical records, lab tests, imaging, and patient questionnaires, with follow-up at roughly 2, 4, and 6 months for the Ursosan group. No treatments are assigned by the study; treatment decisions are made by physicians as part of routine care. The aim is to describe MASLD in this population and to observe how Ursosan use relates to liver health measures over time in routine practice.

Why it matters

Who can join: the full rules

Inclusion Criteria:1. Men and women aged 18 to 65 years. 2. Voluntary willingness to provide informed consent 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:

* 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:

1. Participants undergoing evaluation in Almaty.
2. 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.
3. 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.

2\. Wilson disease, hypobetalipoproteinemia, lysosomal acid lipase deficiency, celiac disease, hemochromatosis, or cryptogenic hepatic steatosis, based on medical history.

3\. Autoimmune 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 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.

Where it's running

• Medical Center of Marat Ospanov West Kazakhstan Medical University
  Aktobe, Aktobe, Kazakhstan Recruiting
• City Polyclinic No. 5
  Almaty, Almaty, Kazakhstan Recruiting
• Research Institute of Cardiology and Internal Diseases
  Almaty, Almaty, Kazakhstan Recruiting
• National Scientific Medical Center
  Astana, Astana, Kazakhstan Recruiting
• Mangystau Regional Multidisciplinary Hospital
  Aktau, Mangystau, Kazakhstan Recruiting
• Saqta Clinic Llp
  Aktau, Mangystau, Kazakhstan Recruiting

Study contacts

• Principal investigator: Almagul Dzhumabayeva, Gastroenterologist — Research Institute of Cardiology and Internal Diseases
• Study coordinator: Almagul Dzhumabayeva, Gastroenterologist
• Email: almusa010@mail.ru
• Phone: +7 701 512 23 26

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Endohepatology-based reclassification of treatment indication in high-risk MASLD

  This study tests whether an endohepatology assessment can change treatment decisions for adults with high-risk MASLD.

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• ALN-CIDEB in adults with MASLD to see if it helps the liver

  This study tests whether ALN-CIDEB can help adults with MASLD and its liver damage compared to placebo.

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  Recruiting at 2 sites University of Palermo · Palermo, Palermo and 1 other locations · NCT07750535

• Taiwan green propolis for MASLD and lipid/metabolic issues

  This study tests whether Taiwan green propolis capsules can improve blood lipids and body fat in adults with MASLD compared to a placebo over 12 weeks.

  Recruiting Taipei Medical University · Dalin · NCT07692438

• Secukinumab retention in adults with plaque psoriasis and MASLD in Spain

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  Recruiting at 9 sites Novartis · Badalona, Barcelona and 8 other locations · NCT07683065

• Automated Passive Case-Finding for Advanced Liver Fibrosis in MASLD

  This program automatically screens high‑risk adults aged 50–75 in primary care to see if they have advanced liver fibrosis and possible MASLD, using routine blood tests and reflex lab tests without extra work for clinicians.

  Recruiting Hospital General Universitario Gregorio Marañon · Madrid, Madrid · NCT07658755

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.