Benefits of Trimetazidine in MASLD Patients

October 6 University

Status and phase: Completed; Phase 2

Conditions: Metabolic Associated Fatty Liver Disease

Treatments: Drug: Trimetazidine; Drug: Placebo; Drug: Conventional therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06140953

REC-H-phBSU-23059

Details and patient eligibility

About

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

Full description

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

Enrollment: 60 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Placebo group (conventional treatment + placebo tablet)

Placebo Comparator group

Description:

placebo tablet (inert substance) + Weight reduction and life style modification(modification in diet like decrease lipids intak).pateints will recieve their conventional therapy

Treatment:

Drug: Conventional therapy

Drug: Placebo

intervention group: drug trimetazidine

Experimental group

Description:

trimetazidine 20 mg three times Aday plus lifestyle modification

Treatment:

Drug: Conventional therapy

Drug: Trimetazidine