What side effects are associated with this type of intervention?

SGLT2 inhibitors, which are being studied for treating Non-alcoholic Fatty Liver Disease (NAFLD), are generally well-tolerated but can have side effects such as urinary tract infections, genital infections, and an increased risk of dehydration due to their diuretic effect. Other common treatments for NAFLD, such as lifestyle modifications and medications like metformin, may cause gastrointestinal issues, while thiazolidinediones can lead to weight gain, edema, and an increased risk of fractures.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments specifically for Non-alcoholic Fatty Liver Disease (NAFLD). However, SGLT2 inhibitors, which are primarily used to treat type 2 diabetes by inhibiting sodium-glucose co-transporter 2 in the kidneys to reduce glucose reabsorption and increase glucose excretion, are being studied for their potential benefits in treating NAFLD. These drugs, such as dapagliflozin, have shown promise in clinical trials for improving liver conditions in patients with diabetes and NAFLD.

What other types of research exist?

Glucagon-like peptide-1 (GLP-1) receptor agonists, such as liraglutide and semaglutide, are promising alternatives to SGLT2 inhibitors for treating Non-alcoholic Fatty Liver Disease (NAFLD). These medications have shown benefits in glycemic control, weight loss, and potential liver health improvements.

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SGLT2 Inhibitor

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

Phase 2

Waitlist Available

Led By Justin Ryder, PhD

Research Sponsored by Ann & Robert H Lurie Children's Hospital of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Tanner stage 2

Elevated alanine aminotransferase (ALT) more than twice the upper limit of normal by gender (≥44 U/L for girls, ≥50 U/L for boys) within 3 months prior to screening (used for historic ALT value) OR diagnosis of NAFLD from ultrasound, MRI, or participants with biopsy-proven NASH within 12 months of screening

Must not have

Structural and functional urogenital abnormalities, that predispose for urogenital infections

Any known causes of liver disease (except NAFLD and NASH)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 26 weeks

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Empagliflozin may cause urinary tract infections, dehydration symptoms like dizziness or fainting, genital yeast infections in girls, increased urination frequency, and potentially low blood sugar levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My body shows early signs of puberty.

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

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

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I am between 12 and 19 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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My kidney function is reduced.

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I have had serious liver-related health events.

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I have taken empagliflozin before.

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I have had cancer in the past.

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I have had weight loss surgery in the past.

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I have Gilbert's Syndrome.

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

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

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

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I have diabetes (type 1 or 2).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 26 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 26 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 26 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy as Measured by Change in Hepatic Fat Fraction (HFF)

Secondary study objectives

Change in Arterial Stiffness

Change in Biomarkers of NAFLD: Alanine transaminase (ALT)

Change in Biomarkers of NAFLD: Cytokeratin (CK)-18

+6 more

Side effects data

From 2019 Phase 2 trial • 80 Patients • NCT03200860

38%

Renal/Urinary

33%

Musculoskeletal

23%

Cardiovascular

23%

Metabolic

15%

Gastrointestinal

15%

Other

Worsening Heart Failure

Respiratory

Worsening Renal Function

S. Aureus Bacteremia

Angioedema

Acute Kidney Injury

Syncope

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Empagliflozin

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Empagliflozin 10 MG

2016

Completed Phase 4

~1110

0 / 16Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

SGLT2 inhibitors, such as dapagliflozin, work by inhibiting the sodium-glucose co-transporter 2 in the kidneys, which reduces glucose reabsorption and increases glucose excretion, thereby lowering blood glucose levels. This is particularly beneficial for NAFLD patients as it helps reduce liver fat and improve insulin sensitivity. GLP-1 receptor agonists, like liraglutide, enhance insulin secretion, inhibit glucagon release, and slow gastric emptying, which collectively help in weight loss and reducing liver fat. Pioglitazone, a thiazolidinedione, improves insulin sensitivity by activating PPAR-gamma receptors, leading to decreased liver fat and inflammation. These mechanisms are crucial for NAFLD patients as they target the underlying metabolic dysfunctions, helping to prevent disease progression and associated complications.