Gepaktiv vs UDCA and Ademetionine in MAFLD With Hepatomegaly

NCT07068191 | Recruiting

• 1 other identifier: GEP-2025-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD); Hepatomegaly; Nonalcoholic Fatty Liver (NAFL); Nonalcoholic Fatty Liver Disease (NAFLD); Fatty Liver; Fatty Liver, Alcoholic; Fatty Liver, Nonalcoholic; Fatty Liver Disease

Keywords

Hepatomegaly; Gepaktiv; Metabolic dysfunction-associated fatty liver disease (MAFLD); metabolic dysfunction-associated steatotic liver disease (MASLD); Nonalcoholic fatty liver disease (NAFLD); liver diseases; Nonalcoholic fatty liver (NAFL); Liver; Liver steatosis; Dietary supplements; Fatty Liver

Outcome Measures

Primary Outcomes (3)

• Reduction in ALT levels by ≥30% from baseline

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

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

• Change in liver size (ultrasound)

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

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

• Improvement in steatosis/fibrosis (FibroScan)

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

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

Study Arms (3)

Group 2 (n=30)

ACTIVE COMPARATOR

Group 2 (n=30): UDCA 10-15 mg/kg/day;

Drug: UDCA (Ursodeoxycholic acid)

Group 3 (n=30)

ACTIVE COMPARATOR

Group 3 (n=30): Ademetionine 800-1600 mg/day.

Drug: Ademetionine

Group 1 (n=30)

EXPERIMENTAL

Participants receive dietary supplement 'Gepaktiv' (2 capsules × 3 times/day, 60 minutes before meals

Combination Product: Dietary supplement "Gepaktiv"

Interventions

Dietary supplement "Gepaktiv" COMBINATION_PRODUCT

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

Group 1 (n=30)

UDCA (Ursodeoxycholic acid) DRUG

UDCA 10-15 mg/kg/day

Group 2 (n=30)

Ademetionine DRUG

Ademetionine 800-1600 mg/day.

Group 3 (n=30)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Phenomen Pharma: lead

Study Sites (1)

Tyumen State Medical University

Tyumen, Tyumen Oblast, 625000, Russia

RECRUITING

MeSH Terms

Conditions

Hepatomegaly; Non-alcoholic Fatty Liver Disease; Fatty Liver; Fatty Liver, Alcoholic; Liver Diseases

Interventions

Ursodeoxycholic Acid; S-Adenosylmethionine

Condition Hierarchy (Ancestors)

Digestive System Diseases; Hypertrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Liver Diseases, Alcoholic; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes; Methionine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Amino Acids; Amino Acids, Peptides, and Proteins; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Central Study Contacts

Evgeniy Chesnokov, MD, Professor

CONTACT

+79091846111; e.v.chesnokov@mail.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Biochemical and imaging data are evaluated by independent assessors blinded to group assignment. Outcome assessors do not have access to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned (1:1:1) to three parallel groups for 15 days: 1. Gepaktiv (dietary supplement, 2 capsules × 3 times/day), 2. UDCA (10-15 mg/kg/day), 3. Ademetionine (800-1600 mg/day). Gepaktiv is a dietary supplement; comparator arms receive standard therapy according to national guidelines. UDCA and Ademetionine are included as standard-of-care active comparators (not investigational drugs). Post-treatment follow-up is optional (up to 60 days). Blinded assessors evaluate outcomes.

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 16, 2025
• Study Start: June 19, 2025
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: July 23, 2025

Record last verified: 2025-07

Locations

RU (1)