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Completed

NCT Number: NCT06140953

Benefits of Trimetazidine in MASLD Patients

Objective of this study is to determine the clinical benefits of trimetazidine in improvement of MASLD

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Key information

Conditions

Metabolic Associated Fatty Liver Disease

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beni-Suef university

Banī Suwayf, Beni Suweif Governorate, 62511, Egypt

About this study

the study will evaluate the possible benefits of trimetazidine when added to pateints with metabolic associated fatty liver disease

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

participants were included if they met MASLD diagnostic criteria, which required imaging-confirmed hepatic steatosis (via abdominal ultrasound and CAP), along with metabolic factors (BMI ≥25 kg/m², diabetes/dysglycemia, blood pressure ≥130/85 mmHg, triglycerides ≥150 mg/dL, or reduced HDL-cholesterol)

Exclusion criteria

The study excluded those with

  • 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

Treatment and study plan

Trimetazidine

Drug

trimetazidine at dose 20 mg three times daily to be taken by intervention group

Conventional therapy

Drug

conventional therapy

Placebo

Drug

placebo tablet (inert substance has the same shape and color of intervention) to be taken by control group only

Primary outcomes

  1. Highly sensitive CRP

    Time frame: measured at baseline and at six months

    Highly sensitive CRP in mg\\dl by chemiillusence.

  2. 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

  3. ALT and AST

    Time frame: measured at baseline and at six months

    ALT, AST in IU/L by blood test.

  4. 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.

  5. 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)

Secondary outcomes

  1. LDL cholesterol

    Time frame: measured at baseline and at six months

    Decrease in LDL in mg\\dl,

  2. Triglyceride and total cholesterol

    Time frame: measured at baseline and at six months

    Triglyceride and total cholesterol in mg\\dl

  3. HOMA-IR

    Time frame: measured at baseline and at six months

    HOMA-IR

  4. IL6 and TNF alpha

    Time frame: measured at baseline and at six months

    IL6 and TNF alpha in pg./ml by Eliza

Sponsors and collaborators

Lead sponsor

October 6 University

Other

Registry information

Official study title

Evaluation of Potential Benefits of Trimetazidine in the Management of Patients With Metabolic Associated Steatotic Liver Disease (MASLD)

Acronym: MASLD

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 21, 2023
Registry last updated
Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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