Gepaktiv vs UDCA and Ademetionine in MAFLD With Hepatomegaly

Not Applicable

Recruiting

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

• Registration Number: NCT07068191
• Lead Sponsor: Phenomen Pharma

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

Detailed 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

Study Timeline

• Study Start: 2025-06-19
• Status Verified: 2025-07
• Primary Completion: 2025-07
• Study First Submitted: 2025-07-07
• Study First Submitted QC: 2025-07-07
• Study First Posted: 2025-07-16
• Last Update Submitted: 2025-07-19
• Last Update Posted: 2025-07-23
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2 (n=30)	UDCA (Ursodeoxycholic acid)	Group 2 (n=30): UDCA 10-15 mg/kg/day;
Group 3 (n=30)	Ademetionine	Group 3 (n=30): Ademetionine 800-1600 mg/day.
Group 1 (n=30)	Dietary supplement "Gepaktiv"	Participants receive dietary supplement 'Gepaktiv' (2 capsules × 3 times/day, 60 minutes before meals

Primary Outcome Measures

Name	Time	Method
Reduction in ALT levels by ≥30% from baseline	15 days (+ optional post-observation up to 60 days).	Proportion of participants achieving ≥30% decrease in serum ALT after 15 days of treatment
Change in liver size (ultrasound)	15 days (+ optional post-observation up to 60 days).	Reduction in liver enlargement (≥1 cm) measured by standardized ultrasound
Improvement in steatosis/fibrosis (FibroScan)	15 days (+ optional post-observation up to 60 days).	Change in CAP (steatosis) and kPa (fibrosis) scores from baseline

Trial Locations

Locations (1)

Tyumen State Medical University; 🇷🇺 Tyumen, Tyumen region, Russian Federation