RedNASHEmpagliflozin for Non-Alcoholic Steatohepatitis
This study aims to assess how well empagliflozin treatment changes liver activity in people with non-alcoholic steatohepatitis over a 12-month period.
Empagliflozin 10 miligrams (mg)
Diabetes Mellitus+11
+ Diabetes Mellitus, Type 2
+ Digestive System Diseases
Treatment Study
Summary
Study start date: April 1, 2024
Actual date on which the first participant was enrolled.This clinical trial aims to determine whether empagliflozin, a medication typically used to treat diabetes, can help improve liver health in adults with non-alcoholic steatohepatitis (NASH). NASH is a liver condition that can lead to serious liver damage, and currently, treatment options are limited. By exploring the effects of empagliflozin over a 48-week period, this study hopes to find a new and effective way to manage this condition. It is important because finding a successful treatment could significantly improve the quality of life for those affected by NASH. Participants in the study will take the drug empagliflozin daily for one year. They will attend regular clinic visits at specific intervals—weeks 1, 2, 4, 12, 24, 36, and 48—to monitor their health and the medication's effects. These visits include a variety of assessments such as blood tests, measurements of liver stiffness using non-invasive methods, and checks on their overall physical health. The study evaluates changes in the liver's condition and overall health indicators to determine if empagliflozin is beneficial in treating NASH. While potential benefits include improved liver health, the study also carefully monitors for any adverse effects throughout the treatment period.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location