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Search / Trial NCT07068191

GEPAKTIV VS UDCA AND ADEMETIONINE IN MAFLD WITH HEPATOMEGALY

Launched by PHENOMEN PHARMA · Jul 7, 2025

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

Hepatomegaly Gepaktiv Metabolic Dysfunction Associated Fatty Liver Disease (Mafld) Metabolic Dysfunction Associated Steatotic Liver Disease (Masld) Nonalcoholic Fatty Liver Disease (Nafld) Liver Diseases Nonalcoholic Fatty Liver (Nafl) Liver Liver Steatosis Dietary Supplements Fatty Liver

ClinConnect Summary

This clinical trial is studying how well a dietary supplement called Gepaktiv works compared to two standard medications (UDCA and Ademetionine) in people with fatty liver disease and an enlarged liver. Fatty liver disease happens when fat builds up in the liver, which can cause liver problems over time. The study aims to see if Gepaktiv can improve liver health by lowering certain liver enzymes, reducing liver size, and decreasing fat in the liver, similar to the standard treatments.

People who might be eligible to join are adults with signs of liver issues, including higher-than-normal liver enzyme levels, a larger liver (enlarged by at least 3 cm), and specific results from a FibroScan test that measures liver fat and stiffness. Participants will take one of the three treatments daily for 15 days. During this time, doctors will monitor their liver health using blood tests and ultrasound scans. This study could help show if Gepaktiv is a safe, natural option to support liver health.

Gender

ALL

Eligibility criteria

  • Laboratory parameters:
  • elevated levels of AST, ALT (90-150 U/L), FibroScan: CAP ≥260 dB/m, kPa ≥8 kPa. enlarged liver - hepatomegaly (+3 cm and above).
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About Phenomen Pharma

Phenomen Pharma is a clinical-stage biopharmaceutical company dedicated to developing innovative therapies to address unmet medical needs. Leveraging advanced scientific research and a patient-centric approach, Phenomen Pharma focuses on bringing novel treatments from discovery through clinical development to improve patient outcomes across a range of therapeutic areas.

Locations

Tyumen, Tyumen Region, Russian Federation

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported