Metabolic Associated Fatty Liver DiseasePhase 2MASLDNCT06140953
Benefits of Trimetazidine in MASLD Patients
A Phase 2 study testing Trimetazidine and Conventional therapy in people with Metabolic Associated Fatty Liver Disease, run by October 6 University at 1 site in Egypt.
Trial summary
Objective of this study is to determine the clinical benefits of trimetazidine in improvement of MASLD Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Metabolic Associated Fatty Liver Disease
- What is being tested?
- Trimetazidine and Conventional therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Dec 2023to 30 Nov 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- alternative steatosis causes (alcohol intake >50 g/day women or >60 g/day men
- drug-induced injury, hepatitis C, Wilson disease).
- Additional exclusion criteria covered ages below 18 years, pregnancy. decompensated cirrhosis, portal hypertension, hepatocellular carcinomas.
- Trimetazidine contraindications (Parkinson's disease, parkinsonian symptoms, tremors, severe renal impairment), patients on statins, sodium glucose transporter 2 inhibitors (SGLT2), glucagon-like peptide 1(GLP1) were among the other exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Potential Benefits of Trimetazidine in the Management of Patients With Metabolic Associated Steatotic Liver Disease (MASLD)
Objective of this study is to determine the clinical benefits of trimetazidine in improvement of MASLD
Read the detailed description
the study will evaluate the possible benefits of trimetazidine when added to pateints with metabolic associated fatty liver disease
- Conditions
- Metabolic Associated Fatty Liver Disease
- Being tested
- Trimetazidine, Conventional therapy, Placebo
- Keywords
- trimetazidine in MASLD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrimetazidineDrug
trimetazidine at dose 20 mg three times daily to be taken by intervention group
conventional therapy
PlaceboDrug
placebo tablet (inert substance has the same shape and color of intervention) to be taken by control group only
| Study group | Role | What they receive |
|---|---|---|
| Placebo group (conventional treatment + placebo tablet) | Placebo comparator | placebo tablet (inert substance) + Weight reduction and life style modification(modification in diet like decrease lipids intak).pateints will recieve their conventional therapy Receives: Drug: Conventional therapy; Drug: Placebo |
| intervention group: drug trimetazidine | Experimental | trimetazidine 20 mg three times Aday plus lifestyle modification Receives: Drug: Trimetazidine; Drug: Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Highly sensitive CRP
Highly sensitive CRP in mg\dl by chemiillusence.
Measured: measured at baseline and at six months
liver Fibrosis and steatosis in db./m
liver Fibrosis and steatosis in db./m fibro scan and fibro cap apparatus
Measured: measured at baseline and at six months
ALT and AST
ALT, AST in IU/L by blood test.
Measured: measured at baseline and at six months
Controlled attenuation parameter (CAP)
A measure of hepatic fat accumulation using transient elastography (Fibro Scan); values typically range from 100 to 400 dB/m, lower values indicate improvement Unit of measure: dB/m.
Measured: measured at baseline and at six months
FAST Score
Fibro Scan-AST score; anon-invasive score to assess the risk of progressive MASH (Metabolic dysfunction-associated steatohepatitis). lower scores indicate improvement Unit of measure: Unitless index (range 0-1)
Measured: at baseline and at six months
Secondary outcomes (4)
LDL cholesterol
Decrease in LDL in mg\dl,
Measured: measured at baseline and at six months
Triglyceride and total cholesterol
Triglyceride and total cholesterol in mg\dl
Measured: measured at baseline and at six months
HOMA-IR
HOMA-IR
Measured: measured at baseline and at six months
IL6 and TNF alpha
IL6 and TNF alpha in pg./ml by Eliza
Measured: measured at baseline and at six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start10 Dec 2023
- Primary completion1 Jun 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Associated Fatty Liver DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha youssif, October 6 University
- Investigators
- Hoda m rabea, Assistant Professor, Principal investigator, Beni-suaf university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06140953
- Sponsor's protocol ID
- REC-H-phBSU-23059
- Acronym
- MASLD
- Status last verified
- Nov 2023
- First submitted
- 26 Oct 2023
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Potential Benefits of Trimetazidine in the Management of Patients With Metabolic Associated Steatotic Liver Disease (MASLD)
- ClinicalTrials.gov ID
- NCT06140953
- Acronym / sponsor ID
- MASLD / REC-H-phBSU-23059
- Conditions
- Metabolic Associated Fatty Liver Disease
- Keywords
- trimetazidine in MASLD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 10 Dec 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 21 Nov 2023 (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.
Objective of this study is to determine the clinical benefits of trimetazidine in improvement of MASLD
Detailed description
the study will evaluate the possible benefits of trimetazidine when added to pateints with metabolic associated fatty liver disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group (conventional treatment + placebo tablet) | Placebo comparator | Drug: Conventional therapy, Drug: Placeboplacebo tablet (inert substance) + Weight reduction and life style modification(modification in diet like decrease lipids intak).pateints will recieve their conventional therapy |
| intervention group: drug trimetazidine | Experimental | Drug: Trimetazidine, Drug: Conventional therapytrimetazidine 20 mg three times Aday plus lifestyle modification |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- alternative steatosis causes (alcohol intake >50 g/day women or >60 g/day men
- drug-induced injury, hepatitis C, Wilson disease).
- Additional exclusion criteria covered ages below 18 years, pregnancy. decompensated cirrhosis, portal hypertension, hepatocellular carcinomas.
- Trimetazidine contraindications (Parkinson's disease, parkinsonian symptoms, tremors, severe renal impairment), patients on statins, sodium glucose transporter 2 inhibitors (SGLT2), glucagon-like peptide 1(GLP1) were among the other exclusion criteria
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 |
|---|---|---|
| Trimetazidinetrimetazidine at dose 20 mg three times daily to be taken by intervention group | Drug | intervention group: drug trimetazidine |
| Conventional therapyconventional therapy | Drug | Placebo group (conventional treatment + placebo tablet), intervention group: drug trimetazidine |
| Placeboplacebo tablet (inert substance has the same shape and color of intervention) to be taken by control group only | Drug | Placebo group (conventional treatment + placebo tablet) |
Primary outcome
Highly sensitive CRP
Time frame: measured at baseline and at six months
Highly sensitive CRP in mg\dl by chemiillusence.
liver Fibrosis and steatosis in db./m
Time frame: measured at baseline and at six months
liver Fibrosis and steatosis in db./m fibro scan and fibro cap apparatus
ALT and AST
Time frame: measured at baseline and at six months
ALT, AST in IU/L by blood test.
Controlled attenuation parameter (CAP)
Time frame: measured at baseline and at six months
A measure of hepatic fat accumulation using transient elastography (Fibro Scan); values typically range from 100 to 400 dB/m, lower values indicate improvement Unit of measure: dB/m.
FAST Score
Time frame: at baseline and at six months
Fibro Scan-AST score; anon-invasive score to assess the risk of progressive MASH (Metabolic dysfunction-associated steatohepatitis). lower scores indicate improvement Unit of measure: Unitless index (range 0-1)
4 secondary outcomes
LDL cholesterol
Time frame: measured at baseline and at six months
Triglyceride and total cholesterol
Time frame: measured at baseline and at six months
HOMA-IR
Time frame: measured at baseline and at six months
IL6 and TNF alpha
Time frame: measured at baseline and at six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Hoda m rabea, Assistant Professor principal investigator
Beni-suaf university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trimetazidine and Conventional therapy in people with Metabolic Associated Fatty Liver Disease, run by October 6 University at 1 site in Egypt.
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 0 inclusion and 4 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: finished, as of the sponsor's last update on 11 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 Egypt. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Highly sensitive CRP (time frame: measured at baseline and at six months). The study lists 5 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 11 Jul 2025.