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

Clinical Study Evaluating the Safety and Efficacy of Esomeprazole in Treatment of Non-alcoholic Steatohepatitis: A Randomized Controlled Trial.

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.

Study Overview

• Status: Recruiting
• Conditions: Steatohepatitis, Nonalcoholic; Fatty Liver Disease
• Intervention / Treatment: Drug: Placebo; Drug: Esomeprazole

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: aya hesham eltabbakh, bachelor; Phone Number: +201094393402; Email: aya.eltabaakh@fop.usc.edu.eg

Study Locations

• Egypt
  • Shibīn Al Kawm, Egypt
    • Recruiting
    • National Liver Institute
    • Contact: National Li Institute; Phone Number: 0482222740

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: esomeprazole group; patients in this arm will receive esomeprazole 20 mg once daily	Drug: Esomeprazole; esomeprazole 20 mg once daily
Placebo Comparator: Placebo group; patients in this arm will receive placebo once daily	Drug: Placebo; Placebo once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in non-alcoholic fatty liver disease (NAFLD) fibrosis score (NFS)	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)	Before and after 3 months of the intervention

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sadat City University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: February 28, 2024
• First Submitted That Met QC Criteria: March 6, 2024
• First Posted (Actual): March 8, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2024
• Last Update Submitted That Met QC Criteria: May 21, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Esomeprazole
• Other Study ID Numbers: 12345 (Other Grant/Funding Number: Reasons for Hope Fund in Prevention and Early Detection of Mental Illness)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be supplied upon a reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No