SGLT2 Inhibitors for Non-Alcoholic Fatty Liver Disease (SLIDE Trial)

Palo Alto (17 mi)

Overseen byJustin Ryder, PhD

Age: < 18

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Prior Safety Data

Approved in 4 jurisdictions

Trial Summary

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.

Eligibility Criteria

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

My body shows early signs of puberty.

My liver enzyme levels are high or I have been diagnosed with fatty liver disease recently.

My BMI is in the obesity range according to my age and sex.

I am between 12 and 19 years old.

Exclusion Criteria

I have urinary or genital issues that increase my risk of infections.

I have liver disease, but it's not due to NAFLD or NASH.

My kidney function is reduced.

I have had serious liver-related health events.

I have taken empagliflozin before.

I have had cancer in the past.

I have had weight loss surgery in the past.

I have Gilbert's Syndrome.

I have a thyroid condition that hasn't been treated.

I have been diagnosed with obesity caused by a single gene.

My liver is functioning well, not more than 5 times above the normal limit.

I have diabetes (type 1 or 2).

Treatment Details

The trial is testing Empagliflozin against a placebo to see if it helps treat NAFLD in obese teens. Participants are randomly assigned to either the drug or placebo group without knowing which one they're getting.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Study interventionExperimental Treatment1 Intervention

Empagliflozin 10 mg will be taken daily

Group II: Control armPlacebo Group1 Intervention

Placebo oral tablet will be taken daily

Empagliflozin is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Jardiance for: