Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD)HEPACTNCT07068191
Gepaktiv vs UDCA and Ademetionine in MAFLD With Hepatomegaly
A study testing Dietary supplement "Gepaktiv", UDCA (Ursodeoxycholic acid) and Ademetionine in people with Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD) and Hepatomegaly, run by Phenomen Pharma at 1 site in Russia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD), Hepatomegaly, Nonalcoholic Fatty Liver (NAFL)
- What is being tested?
- Dietary supplement "Gepaktiv", UDCA (Ursodeoxycholic acid) and Ademetionine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteRussia
- Study dates
- 19 Jun 2025to Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Tyumen State Medical University
Tyumen, Tyumen Oblast, 625000
Irina Nagibina, 89123872991, irina.nagibina@mail.ru
+79091846111, e.v.chesnokov@mail.ru
About this study
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
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:
Read more
- 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
Read the 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):
- Gepaktiv (2 capsules × 3 times daily)
- UDCA (10-15 mg/kg/day)
- Ademetionine (800-1600 mg/day)
- Randomization: 1:1:1 block randomization
Primary Endpoints:
- ≥30% reduction in ALT levels
- Liver size reduction (ultrasound)
- 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
- Conditions
- Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD), Hepatomegaly, Nonalcoholic Fatty Liver (NAFL), Nonalcoholic Fatty Liver Disease (NAFLD), Fatty Liver, Fatty Liver, Alcoholic
- Being tested
- Dietary supplement "Gepaktiv", UDCA (Ursodeoxycholic acid), Ademetionine
- 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
- Medical subject headings
- Hepatomegaly, Non-alcoholic Fatty Liver Disease, Fatty Liver, Fatty Liver, Alcoholic, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary supplement "Gepaktiv"Combination product
Dietary supplement "Gepaktiv" 60 minutes before meals 2 capsules × 3 times/day
UDCA (Ursodeoxycholic acid)Drug
UDCA 10-15 mg/kg/day
AdemetionineDrug
Ademetionine 800-1600 mg/day.
| Study group | Role | What they receive |
|---|---|---|
| Group 2 (n=30) | Active comparator | Group 2 (n=30): UDCA 10-15 mg/kg/day; Receives: Drug: UDCA (Ursodeoxycholic acid) |
| Group 3 (n=30) | Active comparator | Group 3 (n=30): Ademetionine 800-1600 mg/day. Receives: Drug: Ademetionine |
| Group 1 (n=30) | Experimental | Participants receive dietary supplement 'Gepaktiv' (2 capsules × 3 times/day, 60 minutes before meals Receives: Combination Product: Dietary supplement "Gepaktiv" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in ALT levels by ≥30% from baseline
Proportion of participants achieving ≥30% decrease in serum ALT after 15 days of treatment
Measured: 15 days (+ optional post-observation up to 60 days).
Change in liver size (ultrasound)
Reduction in liver enlargement (≥1 cm) measured by standardized ultrasound
Measured: 15 days (+ optional post-observation up to 60 days).
Improvement in steatosis/fibrosis (FibroScan)
Change in CAP (steatosis) and kPa (fibrosis) scores from baseline
Measured: 15 days (+ optional post-observation up to 60 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start19 Jun 2025
- Primary completionJul 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phenomen Pharma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07068191
- Sponsor's protocol ID
- GEP-2025-01
- Acronym
- HEPACT
- Status last verified
- Jul 2025
- First submitted
- 7 Jul 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07068191
- Acronym / sponsor ID
- HEPACT / GEP-2025-01
- Conditions
- Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD), Hepatomegaly, Nonalcoholic Fatty Liver (NAFL), Nonalcoholic Fatty Liver Disease (NAFLD), Fatty Liver, Fatty Liver, Alcoholic
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Phenomen PharmaUniversity, hospital or other
- Study start
- 19 Jun 2025 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 16 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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):
- Gepaktiv (2 capsules × 3 times daily)
- UDCA (10-15 mg/kg/day)
- Ademetionine (800-1600 mg/day)
- Randomization: 1:1:1 block randomization
Primary Endpoints:
- ≥30% reduction in ALT levels
- Liver size reduction (ultrasound)
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 2 (n=30) | Active comparator | Drug: UDCA (Ursodeoxycholic acid)Group 2 (n=30): UDCA 10-15 mg/kg/day; |
| Group 3 (n=30) | Active comparator | Drug: AdemetionineGroup 3 (n=30): Ademetionine 800-1600 mg/day. |
| Group 1 (n=30) | Experimental | Combination Product: Dietary supplement "Gepaktiv"Participants receive dietary supplement 'Gepaktiv' (2 capsules × 3 times/day, 60 minutes before meals |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary supplement "Gepaktiv"Dietary supplement "Gepaktiv" 60 minutes before meals 2 capsules × 3 times/day | Combination product | Group 1 (n=30) |
| UDCA (Ursodeoxycholic acid)UDCA 10-15 mg/kg/day | Drug | Group 2 (n=30) |
| AdemetionineAdemetionine 800-1600 mg/day. | Drug | Group 3 (n=30) |
Primary outcome
Reduction in ALT levels by ≥30% from baseline
Time frame: 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)
Time frame: 15 days (+ optional post-observation up to 60 days).
Reduction in liver enlargement (≥1 cm) measured by standardized ultrasound
Improvement in steatosis/fibrosis (FibroScan)
Time frame: 15 days (+ optional post-observation up to 60 days).
Change in CAP (steatosis) and kPa (fibrosis) scores from baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary supplement "Gepaktiv", UDCA (Ursodeoxycholic acid) and Ademetionine in people with Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD) and Hepatomegaly, run by Phenomen Pharma at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Evgeniy Chesnokov, MD, Professor (+79091846111, e.v.chesnokov@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in ALT levels by ≥30% from baseline (time frame: 15 days (+ optional post-observation up to 60 days).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.