SGLT2 Inhibitors for Non-Alcoholic Fatty Liver Disease
(SLIDE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests empagliflozin, a medication that helps remove extra sugar through urine, in adolescents with obesity and a specific liver condition (NAFLD). The medication works by blocking a protein in the kidneys to help remove sugar from the body. Empagliflozin has been shown to reduce body weight, improve glucose tolerance, and decrease blood pressure in various studies.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, such as weight loss drugs, metformin, and vitamin E supplements, at least 6 months before joining. If you've recently started anti-hypertensive or lipid medications, you may also need to wait 3 months before enrolling.
Is empagliflozin safe for humans?
How is the drug empagliflozin unique for treating non-alcoholic fatty liver disease?
Empagliflozin is unique because it is a type of drug called an SGLT2 inhibitor, which is primarily used to treat type 2 diabetes by helping the kidneys remove sugar from the body. Unlike other treatments for non-alcoholic fatty liver disease, empagliflozin also reduces liver fat and improves liver health, making it a novel option for patients with both diabetes and liver issues.34678
What data supports the effectiveness of the drug Empagliflozin for treating Non-Alcoholic Fatty Liver Disease?
Research shows that Empagliflozin, a type of SGLT2 inhibitor, can reduce liver fat and improve liver health in people with Non-Alcoholic Fatty Liver Disease (NAFLD), both with and without type 2 diabetes. Studies found it significantly decreased liver enzyme levels and liver fat content, suggesting it could be a promising treatment option for NAFLD.12349
Who Is on the Research Team?
Justin Ryder, PhD
Principal Investigator
Ann & Robert H Lurie Children's Hospital of Chicago
Are You a Good Fit for This Trial?
Adolescents aged 12-19 with obesity and non-alcoholic fatty liver disease (NAFLD) can join. They must have high liver enzymes or a confirmed diagnosis of NAFLD/NASH, no significant alcohol intake, no metal implants incompatible with MRI, not pregnant nor planning to be, and without major organ dysfunction or other serious health issues.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive empagliflozin or placebo daily for 26 weeks, with lifestyle/behavioral counseling
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Empagliflozin
- Placebo Oral Tablet
Empagliflozin is already approved in European Union, United States, Canada, Japan for the following indications:
- Type 2 diabetes mellitus
- Heart failure with reduced ejection fraction
- Chronic kidney disease
- Type 2 diabetes mellitus
- Heart failure with reduced ejection fraction
- Chronic kidney disease
- Cardiovascular risk reduction
- Type 2 diabetes mellitus
- Heart failure with reduced ejection fraction
- Chronic kidney disease
- Type 2 diabetes mellitus
- Heart failure with reduced ejection fraction
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ann & Robert H Lurie Children's Hospital of Chicago
Lead Sponsor
University of Minnesota
Lead Sponsor