Hepatogen in Non-Alcoholic Fatty Liver Disease: A Controlled Clinical Trial
Ivashkin V.T., Mayevskaya M.V., Pavlov C.S.
First Moscow State Medical University
Hepatology Research 42(8): 755-762
Abstract
Non-alcoholic fatty liver disease (NAFLD) affects 25% of the global population and can progress to cirrhosis. This controlled trial evaluated Hepatogen (liver peptide complex) in 142 patients with biopsy-proven or ultrasound-confirmed NAFLD. Patients received Hepatogen (20mg orally, twice daily for 60 days, n=72) or standard lifestyle modification alone (n=70). Primary endpoints were liver enzyme normalization and reduction in hepatic steatosis grade on ultrasound. After 60 days, the Hepatogen group showed significant ALT reduction (from 87.3±24.6 to 38.2±18.4 U/L vs. control reduction to 64.7±22.1, p<0.001). AST normalized in 68% of Hepatogen patients vs. 32% controls. Ultrasound grading improved by ≥1 grade in 61% vs. 23% (p<0.001). Serum markers of fibrosis (FIB-4 score) decreased significantly. Patients reported improved fatigue and abdominal discomfort. Lipid profiles showed reduced triglycerides and LDL. In a subset of 24 patients undergoing repeat liver biopsy, Hepatogen reduced steatosis score and lobular inflammation.
Study Population
NAFLD patients (age 35-65 years), BMI 27-35 kg/m², elevated ALT/AST, no viral hepatitis or alcohol use >20g/day
The Epidemic
Non-alcoholic fatty liver disease (NAFLD) is the most common liver disease worldwide, affecting 1 in 4 adults. It can progress to cirrhosis and liver cancer. Current treatments are limited to lifestyle changes, which many patients struggle to maintain.
Study Design
Patients with confirmed NAFLD received either Hepatogen plus standard care or standard care alone, allowing assessment of the peptide's specific contribution.
Results
Liver Enzyme Normalization
ALT (the primary liver damage marker) decreased to normal levels in the Hepatogen group, while remaining elevated in controls.
Fat Reduction
Ultrasound showed 61% of Hepatogen patients had reduction in liver fat content vs. only 23% of controls - a breakthrough finding.
Inflammation Reduction
In the subset who underwent repeat liver biopsy, 79% showed reduced inflammation on microscopic examination.
Metabolic Benefits
Beyond the liver, patients experienced:
- 23% reduction in triglycerides
- Improved LDL cholesterol
- Reduced abdominal discomfort and fatigue
Significance
Hepatogen offers the first peptide-based approach to NAFLD that demonstrates objective improvements in liver pathology. This could address a major unmet medical need in hepatology.
Statistical Results
ALT reduction: to 38.2±18.4 U/L vs. control 64.7±22.1 (p<0.001). AST normalization: 68% vs. 32% (p<0.001). Steatosis grade improvement: 61% vs. 23% (p<0.001). FIB-4 score decrease: -0.42±0.18 (p<0.01). Triglycerides: -23% reduction (p<0.01). Repeat biopsy (n=24): steatosis score reduced 1.2±0.4 grades, inflammation reduced in 79%.
Study Limitations
- •Non-randomized design
- •Limited to moderate NAFLD (excludes advanced fibrosis/cirrhosis)
- •Relatively short treatment duration
- •Only small subset had repeat liver biopsy
- •Single country population
Adverse Events
- •Mild nausea (6.9%)
- •No hepatotoxicity
- •No serious adverse events
- •Excellent safety profile
Key Findings
- ✓Liver enzyme normalization
- ✓Significant reduction in hepatic steatosis
- ✓Decreased liver inflammation on biopsy
- ✓Improved metabolic parameters
- ✓Excellent safety profile
Mechanism of Action
Enhancement of hepatocyte protein synthesis, stimulation of lipid metabolism and export, reduction of oxidative stress, and anti-inflammatory effects.