Benefits of Trimetazidine in MASLD Patients

Phase 2

Completed

• Conditions: Metabolic Associated Fatty Liver Disease
• Interventions: Drug: Conventional therapy; Drug: Trimetazidine; Drug: Placebo

• Registration Number: NCT06140953
• Lead Sponsor: October 6 University

Brief Summary

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 Timeline

• Study Start: 2023-06-10
• Study First Submitted: 2023-10-26
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-18
• Study First Posted: 2023-11-21
• Primary Completion: 2024-06-01
• Study Completion: 2024-11-30
• Last Update Submitted: 2025-04-12
• Last Update Posted: 2025-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group (conventional treatment + placebo tablet)	Conventional therapy	placebo tablet (inert substance) + Weight reduction and life style modification(modification in diet like decrease lipids intak).pateints will recieve their conventional therapy
Placebo group (conventional treatment + placebo tablet)	Placebo	placebo 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	Trimetazidine	trimetazidine 20 mg three times aday
intervention group: drug trimetazidine	Conventional therapy	trimetazidine 20 mg three times aday

Primary Outcome Measures

Name	Time	Method
incidence in mafld	"1 Year "	ALT,AST in unit\\liter by blood test.
CAP score and FAST score	1 year	Controlled atteuated parameter and fibrosis to AST score

Secondary Outcome Measures

Name	Time	Method
incidence of mafld	"1 Year "	IL6,TNF alpha in mg\\l by eliza

Trial Locations

Locations (1)

Maha Youssif Fekry; 🇪🇬 Giza, Egypt