Benefits of Trimetazidine in MASLD Patients

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06140953

Acronym

MASLD

Enrollment

Registered

2023-11-21

Start date

2023-12-10

Completion date

2024-11-30

Last updated

2025-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Associated Fatty Liver Disease

Keywords

trimetazidine in MASLD

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

Interventions

DRUGTrimetazidine

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

DRUGConventional therapy

conventional therapy

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
FAST Score	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)
Highly sensitive CRP	measured at baseline and at six months	Highly sensitive CRP in mg\\dl by chemiillusence.
liver Fibrosis and steatosis in db./m	measured at baseline and at six months	liver Fibrosis and steatosis in db./m fibro scan and fibro cap apparatus
ALT and AST	measured at baseline and at six months	ALT, AST in IU/L by blood test.
Controlled attenuation parameter (CAP)	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.

Secondary

Measure	Time frame	Description
Triglyceride and total cholesterol	measured at baseline and at six months	Triglyceride and total cholesterol in mg\\dl
HOMA-IR	measured at baseline and at six months	HOMA-IR
IL6 and TNF alpha	measured at baseline and at six months	IL6 and TNF alpha in pg./ml by Eliza
LDL cholesterol	measured at baseline and at six months	Decrease in LDL in mg\\dl,

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026