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NCT Number: NCT07068191

Gepaktiv vs UDCA and Ademetionine in MAFLD With Hepatomegaly

This study compares the effectiveness of the dietary supplement Gepaktiv with standard medications (UDCA and Ademetionine) in patients with fatty liver disease (MAFLD) and liver enlargement (hepatomegaly).

Key points:

* Participants will receive either Gepaktiv, UDCA, or Ademetionine for 15 days * Doctors will monitor liver health through blood tests and ultrasound scans * The study will check if Gepaktiv helps improve liver function as effectively as standard treatments.

Main measurements:

* Changes in liver enzyme levels (ALT, AST) * Reduction in liver size * Improvement in fat accumulation (steatosis) measured by FibroScan This research may provide evidence for a new natural option to support liver health.Data analysis will be done by an independent biostatistics

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Key information

Conditions

Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD) Alcohol-Induced Disorders Alcohol-Related Disorders Chemically-Induced Disorders Digestive System Diseases Fatty Liver Fatty Liver Disease Fatty Liver, Alcoholic Fatty Liver, Nonalcoholic Hepatomegaly Hypertrophy Liver Diseases Liver Diseases, Alcoholic Non-alcoholic Fatty Liver Disease Nonalcoholic Fatty Liver (NAFL) Nonalcoholic Fatty Liver Disease (NAFLD) Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

This randomized, open-label, parallel-group study evaluates the hepatoprotective effects of the dietary supplement Gepaktiv (250 mg capsules) compared to ursodeoxycholic acid (UDCA) and ademetionine in 90 patients with metabolic-associated fatty liver disease (MAFLD) and hepatomegaly.

Study Design:

  • Duration: 15-day treatment with optional 60-day follow-up
  • 3 treatment arms (n=30 each):
  • Gepaktiv (2 capsules × 3 times daily)
  • UDCA (10-15 mg/kg/day)
  • Ademetionine (800-1600 mg/day)
  • Randomization: 1:1:1 block randomization

Primary Endpoints:

  • ≥30% reduction in ALT levels
  • Liver size reduction (ultrasound)
  • Improvement in FibroScan parameters (CAP for steatosis, kPa for fibrosis)

Secondary Endpoints:

  • Changes in other liver enzymes (AST, GGT, bilirubin)
  • Lipid profile (triglycerides, cholesterol)
  • Albumin and total protein levels
  • Quality of life assessment (CLDQ questionnaire)

Methodology Highlights:

  • Standardized ultrasound protocol (single operator)
  • Central laboratory analysis of biomarkers
  • All efficacy-related assessments (FibroScan, ultrasound, and laboratory blood tests) are performed by blinded evaluators who are not involved in patient management or aware of group assignment
  • Daily compliance monitoring through patient diaries

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Dietary supplement "Gepaktiv"

Combination Product

Dietary supplement "Gepaktiv" 60 minutes before meals 2 capsules × 3 times/day

UDCA (Ursodeoxycholic acid)

Drug

UDCA 10-15 mg/kg/day

Ademetionine

Drug

Ademetionine 800-1600 mg/day.

Primary outcomes

  1. Reduction in ALT levels by ≥30% from baseline

    Time frame: 15 days (+ optional post-observation up to 60 days).

    Proportion of participants achieving ≥30% decrease in serum ALT after 15 days of treatment

  2. Change in liver size (ultrasound)

    Time frame: 15 days (+ optional post-observation up to 60 days).

    Reduction in liver enlargement (≥1 cm) measured by standardized ultrasound

  3. Improvement in steatosis/fibrosis (FibroScan)

    Time frame: 15 days (+ optional post-observation up to 60 days).

    Change in CAP (steatosis) and kPa (fibrosis) scores from baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Evgeniy Chesnokov, MD, Professor

CONTACT

[email protected]

+79091846111

Sponsors and collaborators

Lead sponsor

Phenomen Pharma

Other

Registry information

Official study title

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

Acronym: HEPACT

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 16, 2025
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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