Gepaktiv compared with UDCA and Ademetionine for MAFLD with enlarged liver
Randomized Comparative Clinical Study of the Dietary Supplement "Gepaktiv" (International Name: Phenomenon) in Comparison With Ursodeoxycholic Acid (UDCA) and Ademetionine in Patients With Metabolic Associated Fatty Liver Disease (MAFLD) and Hepatomegaly
This study will try the dietary supplement Gepaktiv to see if it improves liver enzymes, liver size, and fat in adults with MAFLD and hepatomegaly compared with UDCA and ademetionine.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Phenomen Pharma Academic / other |
| Locations | 1 site (Tyumen, Tyumen Oblast) |
| Trial ID | NCT07068191 on ClinicalTrials.gov |
What this trial studies
This randomized, open-label, parallel-group trial enrolls 90 adults with MAFLD and hepatomegaly who are randomized 1:1:1 to Gepaktiv, ursodeoxycholic acid (UDCA), or ademetionine for 15 days with an optional 60-day follow-up. Primary outcomes are a ≥30% reduction in ALT, ultrasound-measured liver size, and FibroScan measures of steatosis (CAP) and fibrosis (kPa), with blood tests and ultrasound performed at baseline and end of treatment. All efficacy-related assessments are done by evaluators blinded to treatment assignment and biomarkers are analyzed in a central laboratory, while daily compliance is monitored via patient diaries. The Gepaktiv arm uses 250 mg capsules given two capsules three times daily and is compared against standard dosing regimens for UDCA and ademetionine.
Who should consider this trial
Good fit: Adults aged 18–65 with confirmed MAFLD, hepatomegaly by ultrasound (≥3 cm craniocaudal enlargement), ALT 90–150 U/L, CAP ≥260 dB/m, fibrosis ≥11 kPa on FibroScan, and ability to comply with study visits.
Not a fit: People with cirrhosis, hepatocellular carcinoma, pregnancy or lactation, gallstones or biliary obstruction, shrunken liver, significant hepatic cysts or nodules, allergy to study agents, or who fall outside the specified lab or imaging ranges are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, Gepaktiv could offer a convenient, natural alternative to standard medications to lower liver enzymes, reduce liver size, and reduce liver fat in people with MAFLD and hepatomegaly.
How similar studies have performed: UDCA and ademetionine have shown mixed or modest effects in fatty liver disorders in prior trials, while Gepaktiv as a supplement is novel and lacks randomized evidence in this indication.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Tyumen, Tyumen Oblast
- Tyumen State Medical University — Tyumen, Tyumen Oblast, Russia (Recruiting)
Study contacts
- Study coordinator: Evgeniy Chesnokov, MD, Professor
- Email: e.v.chesnokov@mail.ru
- Phone: +79091846111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.