Background Metabolic-associated fatty liver disease (MAFLD) is a prevalent chronic liver condition with limited approved pharmacological treatments [1]. Ursodeoxycholic acid (UDCA) and ademetionine show variable efficacy, primarily on liver enzymes. This study presents a preliminary analysis comparing the efficacy of a novel dietary supplement, Gepaktiv, against these comparators in MAFLD patients.

Methods In this open-label, randomized controlled trial (clinicaltrials.gov NCT07068191 and ITMCTR 2025001469), 19 patients with MAFLD, confirmed by hepatomegaly (liver size ≥3 cm above normal by ultrasound), elevated alanine aminotransferase (ALT, 90–150 U/L), and FibroScan results (steatosis ≥260 dB/m, fibrosis ≥11 kPa), were allocated to Gepaktiv (n=6, 1500 mg/day), UDCA (n=7, 10 mg/kg/day), or Ademetionine (n=6, orally 400 mg 2 times a day) for 15 days. Patients with significant alcohol consumption (>20 g/day for women, >30 g/day for men) were excluded. Primary outcomes were median changes from baseline to day 15 in ALT, aspartate aminotransferase (AST), liver size (craniocaudal diameter, cm, via ultrasound), steatosis (controlled attenuation parameter, CAP, dB/m), and fibrosis (transient elastography, kPa).

Results The Gepaktiv group showed median [IQR] reductions of ALT -48.9 [-54.0 to -35.0] U/L, AST - 62.8 [-66.0 to -44.0] U/L, liver size -1.9 [-2.0 to -1.2] cm, and steatosis -32.5 [-45.0 to -30.0] dB/m. These reductions were significantly greater compared to both UDCA and Ademetionine groups (p < 0.01 for ALT, AST, and liver size; p < 0.05 for steatosis). Fibrosis reduction was minimal and not statistically significant between groups.

Conclusion The Gepaktiv group was associated with greater improvements in biochemical and imaging markers of MAFLD compared to UDCA and Ademetionine in this preliminary analysis. These findings warrant further investigation in larger, long-term trials.

Note: These preliminary results have not been peer-reviewed and should not guide clinical practice.

The author declare a competing interest. This study was funded by Phenomenon Pharma LLC, the manufacturer of the investigated product Gepaktiv (Phenomenon). The funding entity had no influence on the study design, data collection, analysis, interpretation, or manuscript preparation. The author confirms his independence in conducting the research and presenting the results.

NCT07068191, ITMCTR2025001469

https://clinicaltrials.gov/study/NCT07068191

This work was supported by a research grant from Phenomenon Pharma LLC. The funder (Phenomenon Pharma LLC) provided the investigational product (Gepaktiv) and financial support for the conduct of the research but had no role in the design of the study, the collection, analysis, or interpretation of data, the writing of the manuscript, or in the decision to submit the manuscript for publication.

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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The Tyumen State Medical University Ethics Committee gave ethical approval for this work (Protocol № 131, 30 June 2025).

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