Gepaktiv compared with UDCA and Ademetionine for MAFLD with enlarged liver
Official 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
Run by Phenomen Pharma · NCT07068191 · Data updated 2026-11-12
This study will try the dietary supplement Gepaktiv to see if it improves liver enzymes, liver size, and fat in adults with MAFLD and hepatomegaly compared with UDCA and ademetionine.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | Phenomen Pharma Academic / other |
| Locations | 1 site (Tyumen, Tyumen Oblast) |
| Status | Recruiting |
| Started | June 19, 2025 |
| Main results expected | July 2025 |
| Study ends | August 2025 |
| Registry record updated | July 23, 2025 |
| Trial ID | NCT07068191 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–65 with confirmed MAFLD, hepatomegaly by ultrasound (≥3 cm craniocaudal enlargement), ALT 90–150 U/L, CAP ≥260 dB/m, fibrosis ≥11 kPa on FibroScan, and ability to comply with study visits.
✕Probably not a fit
People with cirrhosis, hepatocellular carcinoma, pregnancy or lactation, gallstones or biliary obstruction, shrunken liver, significant hepatic cysts or nodules, allergy to study agents, or who fall outside the specified lab or imaging ranges are unlikely to benefit from this trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, open-label, parallel-group trial enrolls 90 adults with MAFLD and hepatomegaly who are randomized 1:1:1 to Gepaktiv, ursodeoxycholic acid (UDCA), or ademetionine for 15 days with an optional 60-day follow-up. Primary outcomes are a ≥30% reduction in ALT, ultrasound-measured liver size, and FibroScan measures of steatosis (CAP) and fibrosis (kPa), with blood tests and ultrasound performed at baseline and end of treatment. All efficacy-related assessments are done by evaluators blinded to treatment assignment and biomarkers are analyzed in a central laboratory, while daily compliance is monitored via patient diaries. The Gepaktiv arm uses 250 mg capsules given two capsules three times daily and is compared against standard dosing regimens for UDCA and ademetionine.
Why it matters
Potential benefit: If successful, Gepaktiv could offer a convenient, natural alternative to standard medications to lower liver enzymes, reduce liver size, and reduce liver fat in people with MAFLD and hepatomegaly.
How similar studies have gone: UDCA and ademetionine have shown mixed or modest effects in fatty liver disorders in prior trials, while Gepaktiv as a supplement is novel and lacks randomized evidence in this indication.
Who can join: the full rules
Show full inclusion / exclusion criteria
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)
Where it's running
-
Tyumen State Medical University
Tyumen, Tyumen Oblast, Russia Recruiting
Study contacts
- Study coordinator: Evgeniy Chesnokov, MD, Professor
- Email: e.v.chesnokov@mail.ru
- Phone: +79091846111
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Intermittent fasting to treat fatty liver disease in non-obese adults
This study is testing if intermittent fasting can help non-obese adults with fatty liver disease improve their liver health and overall well-being.
-
NMR-based Risk Test and Digital Health Support for midlife adults in Eloisa
This study tests whether an NMR metabolomics risk test can guide tailored digital health programs for midlife adults at risk of diabetes, heart disease, stroke, kidney disease, or fatty liver.
-
Metabolic Liver Disease in People Newly Diagnosed with HIV
This study tests whether HIV-infected adults who are starting ART are more likely to develop MASLD and related liver issues than HIV-negative adults over five years.
-
NAFLD in Obese Chinese Patients Undergoing Bariatric Surgery
This study tests how NAFLD progresses and which biomarkers appear in obese Chinese adults undergoing laparoscopic bariatric surgery.
-
Peanut intake and liver health in adults with MASLD
This study tests whether adding peanuts to daily meals for 12 weeks can improve liver markers and metabolic health in adults with MASLD.
-
Photon-counting CT and ultrasound for detecting liver fat and scarring
This will test whether a new photon-counting CT plus ultrasound can find liver fat and scarring in adults with fatty liver or liver fibrosis, using MRI as the reference.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.