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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Tyumen, Tyumen Region, Russian Federation
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported