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

NCT06302049 | Recruiting Phase 1

• 1 other identifier: 12345
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Fatty Liver Disease; Steatohepatitis, Nonalcoholic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Liver function improvement

  Before and after 3 months of the intervention

• Reduction of oxidative stress

  Before and after 3 months of the intervention

Study Arms (2)

esomeprazole group

EXPERIMENTAL

patients in this arm will receive esomeprazole 20 mg once daily

Drug: Esomeprazole

Placebo group

PLACEBO COMPARATOR

patients in this arm will receive placebo once daily

Drug: Placebo

Interventions

Esomeprazole DRUG

esomeprazole 20 mg once daily

esomeprazole group

Placebo DRUG

Placebo once daily

Placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sadat City University: lead

Study Sites (1)

National Liver Institute

Shibīn al Kawm, Egypt

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

aya hesham eltabbakh, bachelor

CONTACT

+201094393402; aya.eltabaakh@fop.usc.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 8, 2024
• Study Start: June 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2026
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)