Evaluating esomeprazole for treating non-alcoholic steatohepatitis
Clinical Study Evaluating the Safety and Efficacy of Esomeprazole in Treatment of Non-alcoholic Steatohepatitis: A Randomized Controlled Trial.
This study is testing if the medication esomeprazole can help people with non-alcoholic steatohepatitis improve their liver health and overall condition.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sadat City University Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Shibīn al Kawm) |
| Trial ID | NCT06302049 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to assess the safety and efficacy of esomeprazole as a potential therapy for patients with non-alcoholic steatohepatitis (NASH). It will evaluate the drug's effects on ultrasound and fibrosis risk scores, as well as serum levels of liver fibrosis biomarkers, insulin resistance, and various metabolic and inflammatory parameters. The study will involve both diabetic and non-diabetic patients aged over 18 with a body mass index between 25 and 40 kg/m2. Participants will be randomly assigned to receive either esomeprazole or a placebo.
Who should consider this trial
Good fit: Ideal candidates include overweight or obese adults with a confirmed diagnosis of NASH and mild to moderate liver enzyme elevation.
Not a fit: Patients with a history of hypersensitivity to esomeprazole or those with a BMI of 40 kg/m2 or higher may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic option for patients suffering from non-alcoholic steatohepatitis.
How similar studies have performed: While there have been studies exploring various treatments for NASH, the specific use of esomeprazole in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Shibīn al Kawm
- National Liver Institute — Shibīn al Kawm, Egypt (Recruiting)
Study contacts
- Study coordinator: aya hesham eltabbakh, bachelor
- Email: aya.eltabaakh@fop.usc.edu.eg
- Phone: +201094393402
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.