The Leukotriene Receptor Antagonist Montelukast in the Treatment of Non-alcoholic Steatohepatitis

The Leukotriene Receptor Antagonist Montelukast in the Treatment of Non-alcoholic Steatohepatitis: A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04080947

Enrollment

Registered

2019-09-06

Start date

2019-08-01

Completion date

2022-03-15

Last updated

2022-03-16

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

Conditions

Steatohepatitis, Nonalcoholic

Brief summary

The aim of the current study is to evaluate the safety and efficay of Montelukast in treatment of patients with fatty liver disease.

Interventions

DRUGControl group

patients received matching-image placebo once daily at bedtime for 12 weeks.

DRUGMontelukast group

patients received montelukast (10-mg chewable tablet) once daily at bedtime for 12 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

\- The inclusion criteria were adult patients (age \>18 years old) of both sexes, overweight/obese subjects with presence of evidence of hepatic steatosis by imaging (increased liver echogenicity, stronger echoes in the hepatic parenchyma, vessel blurring, and narrowing of the lumen of the hepatic veins). Patients with mild to moderate elevation in aminotransferase activities (\> 2 but \<5 times upper limit of normal), hepatic steatosis index (HIS) \>36, Fibro-scan score \>7 kpa and \<12.5 kpa (F0-F3), and HAIR score of 2 or 3 were included in the study.

Exclusion criteria

\- The

Design outcomes

Primary

Measure	Time frame	Description
Fibro-scan score	At baseline and after 12 weeks of intervention	change in liver stiffness measurement (Fibro-scan score)
Liver Panel	after 12 weeks of intervention	Alanine aminotransferase (ALT) and Aspartate Aminotransferase (AST) will be evaluated in U/L

Secondary

Measure	Time frame	Description
TNF-Alpha	after 12 weeks of intervention	Serum level of TNF-Alpha
hyaluronic acid	after 12 weeks of intervention	Serum level of hyaluronic acid
HOMA-IR	after 12 weeks of intervention	Homeostatic Model Assessment of Insulin Resistance
Assessment of drugs tolerability: Side effects	after 12 weeks of intervention	Side effects of montelukast
TGF-β1	after 12 weeks of intervention	Serum level of TGF-β1
8-OHdG	after 12 weeks of intervention	Serum level of 8-OHdG

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026