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

Sadat City University

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Steatohepatitis, Nonalcoholic; Fatty Liver Disease

Treatments: Drug: Esomeprazole; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06302049

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Details and patient eligibility

About

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.

Enrollment: 46 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 2 patient groups, including a placebo group

esomeprazole group

Experimental group

Description:

patients in this arm will receive esomeprazole 20 mg once daily

Treatment:

Drug: Esomeprazole

Placebo group

Placebo Comparator group

Description:

patients in this arm will receive placebo once daily

Treatment:

Drug: Placebo