Gepaktiv vs UDCA and Ademetionine in MAFLD With Hepatomegaly

Launched by PHENOMEN PHARMA · Jul 7, 2025

Keywords

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.

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Eligibility criteria

• Inclusion Criteria:
• • Age 18 to 65 years
• • Confirmed diagnosis of metabolic-associated fatty liver disease (MAFLD)
• • Hepatomegaly confirmed by ultrasound (≥3 cm craniocaudal liver enlargement)
• • ALT level between 90-150 U/L
• • Steatosis ≥260 dB/m by FibroScan (CAP)
• • Fibrosis ≥11 kPa by transient elastography (FibroScan)
• • Ability to comply with study procedures
• • Signed informed consent
• Exclusion Criteria:
• • Liver cirrhosis or hepatocellular carcinoma
• • Pregnancy or lactation
• • Known allergy to any of the study medications or supplement components
• • Gallstones or biliary obstruction
• • Shrunken liver on imaging
• • Hepatic cysts (simple liver cysts/biliary cysts)
• • Liver nodules (focal liver lesions)