Gepaktiv vs UDCA and Ademetionine in MAFLD With Hepatomegaly (HEPACT)

Phenomen Pharma

Status: Enrolling

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

Treatments: Combination Product: Dietary supplement "Gepaktiv"; Drug: Ademetionine; Drug: UDCA (Ursodeoxycholic acid)

Study type: Interventional

Funder types: Other

Identifiers

NCT07068191

GEP-2025-01

Details and patient eligibility

About

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

Full description

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):

  1. Gepaktiv (2 capsules × 3 times daily)
  2. UDCA (10-15 mg/kg/day)
  3. Ademetionine (800-1600 mg/day)

• Randomization: 1:1:1 block randomization

Primary Endpoints:

1. ≥30% reduction in ALT levels
2. Liver size reduction (ultrasound)
3. 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

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

Group 2 (n=30)

Active Comparator group

Description:

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

Treatment:

Drug: UDCA (Ursodeoxycholic acid)

Group 3 (n=30)

Active Comparator group

Description:

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

Treatment:

Drug: Ademetionine

Group 1 (n=30)

Experimental group

Description:

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

Treatment:

Combination Product: Dietary supplement "Gepaktiv"