Benefits of Trimetazidine in MASLD Patients

NCT06140953 | Completed Phase 2 DMC

• 1 other identifier: REC-H-phBSU-23059
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metabolic Associated Fatty Liver Disease

Keywords

trimetazidine in MASLD

Outcome Measures

Primary Outcomes (5)

• Highly sensitive CRP

  Highly sensitive CRP in mg\\dl by chemiillusence.

  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 at baseline and at six months

• ALT and AST

  ALT, AST in IU/L by blood test.

  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 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)

  at baseline and at six months

Secondary Outcomes (4)

• LDL cholesterol

  measured at baseline and at six months

• Triglyceride and total cholesterol

  measured at baseline and at six months

• HOMA-IR

  measured at baseline and at six months

• IL6 and TNF alpha

  measured at baseline and at six months

Study Arms (2)

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

Drug: Conventional therapy; Drug: Placebo

intervention group: drug trimetazidine

EXPERIMENTAL

trimetazidine 20 mg three times Aday plus lifestyle modification

Drug: Trimetazidine; Drug: Conventional therapy

Interventions

Trimetazidine DRUG

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

intervention group: drug trimetazidine

Conventional therapy DRUG

conventional therapy

Placebo group (conventional treatment + placebo tablet); intervention group: drug trimetazidine

Placebo DRUG

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

Placebo group (conventional treatment + placebo tablet)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• alternative steatosis causes (alcohol intake \>50 g/day women or \>60 g/day men
• drug-induced injury, hepatitis C, Wilson disease).

Sponsors & Collaborators

• October 6 University: lead

Study Sites (1)

Beni-Suef university

Banī Suwayf, Beni Suweif Governorate, 62511, Egypt

Location

MeSH Terms

Interventions

Trimetazidine

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Hoda m rabea, Assistant Professor

  Beni-suaf university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 21, 2023
• Study Start: December 10, 2023
• Primary Completion: June 1, 2024
• Study Completion: November 30, 2024
• Last Updated: July 11, 2025

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)