Clinical Study Evaluating the Safety and Efficacy of Esomeprazole in Treatment of Non-alcoholic Steatohepatitis

Phase 1

Recruiting

• Conditions: Fatty Liver Disease; Steatohepatitis, Nonalcoholic
• Interventions: Drug: Esomeprazole; Drug: Placebo

• Registration Number: NCT06302049
• Lead Sponsor: Sadat City University

Brief Summary

The aim of the study is to test the implication of esomeprazole as a possible potential therapy for patients with NASH through evaluating its effect on ultrasound and fibrosis risk scores, serum levels of liver fibrosis biomarkers (fibronectin 1), insulin resistance, metabolic and inflammatory parameters.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-28
• Study First Submitted QC: 2024-03-06
• Study First Posted: 2024-03-08
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-21
• Last Update Posted: 2024-05-22
• Study Start: 2024-06-01
• Primary Completion: 2025-05-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Both males and females.

• Diabetic and non-diabetic patients.
• Age >18 years old.
• Overweight and obese patient: Body mass index (BMI) ≥ 25 kg/ m2 but <40 kg/ m2.
• Patients with heartburn, peptic ulcer, gastrointestinal reflux disease, erosive esophagitis, Zollinger-Ellison syndrome and helicobacter pylori infection.
• Patients with established diagnosis of NASH based on liver ultrasonography, mild to moderate elevation in aminotransferase activities (>2 but <5 times upper limit of normal), hepatic steatosis index (HIS) >36, HAIR score of 2 or 3.

Exclusion Criteria

• Patients with a history of hypersensitivity to esomeprazole.
• Patients with BMI ≥ 40 kg/ m2.
• Patients taking warfarin, clopidogrel, digoxin, diazepam and phenytoin to avoid drug-drug interactions as these drugs are CYP2C19 substrates.
• Patients infected with human immune deficiency virus taking antiretroviral medicines or dosage forms containing rilpivirine.
• Patients with a history of viral hepatitis, autoimmune hepatitis, sclerosing cholangitis, biliary obstruction, primary biliary cirrhosis, hemochromatosis, Wilson's disease and alpha-1 antitrypsin deficiency.
• Patients on medications associated with steatosis such as NSAIDs, amiodarone, tamoxifen, estrogen, sodium valproate, corticosteroids, and methotrexate.
• Patients with cancer or with a history of cancer.
• Patients with cardiovascular diseases.
• Pregnant and lactating females

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
esomeprazole group	Esomeprazole	patients in this arm will receive esomeprazole 20 mg once daily
Placebo group	Placebo	patients in this arm will receive placebo once daily

Primary Outcome Measures

Name	Time	Method
Change in non-alcoholic fatty liver disease (NAFLD) fibrosis score (NFS)	Before and after 3 months of the intervention	Increase in NAFLD fibrosis score indicates high probability of advanced liver fibrosis Score lower than -1.5 indicates low probability of advanced liver fibrosis (F0-F2).; Score higher than or equals -1.5 to \< 0.67 indicates intermediate probability of advanced liver fibrosis.; Score higher than or equals 0.67 indicates high probability of advanced liver fibrosis (F3-F4)

Secondary Outcome Measures

Name	Time	Method
Liver function improvement	Before and after 3 months of the intervention	change in the other measured parameters such as liver panel
Reduction of oxidative stress	Before and after 3 months of the intervention	Decrease in the serum level of malondialdehyde (MDA)

Trial Locations

Locations (1)

National Liver Institute; 🇪🇬 Shibīn Al Kawm, Egypt