40 Participants Needed

SGLT2 Inhibitors for Non-Alcoholic Fatty Liver Disease

(SLIDE Trial)

Recruiting at 1 trial location
KM
PL
AF
JR
Overseen ByJustin Ryder, PhD
Age: < 18
Sex: Any
Trial Phase: Phase 2
Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

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.

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.12345

Is empagliflozin safe for humans?

Empagliflozin, a type of SGLT2 inhibitor, has been studied in clinical trials and is generally considered safe for humans, with trials showing it can reduce liver fat and improve liver enzyme levels in patients with non-alcoholic fatty liver disease and type 2 diabetes.12356

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.23789

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.

Research Team

JR

Justin Ryder, PhD

Principal Investigator

Ann & Robert H Lurie Children's Hospital of Chicago

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 BMI is in the obesity range according to my age and sex.
I am willing to follow specific lifestyle guidelines during the study.
See 8 more

Exclusion Criteria

Impaired fasting glucose (>100 mg/dL)
INR 1.3
I have urinary or genital issues that increase my risk of infections.
See 27 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive empagliflozin or placebo daily for 26 weeks, with lifestyle/behavioral counseling

26 weeks
Regular visits for physical exams, lab tests, and imaging

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Empagliflozin
  • Placebo Oral Tablet
Trial Overview 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.
Participant Groups
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:
  • Type 2 diabetes mellitus
  • Heart failure with reduced ejection fraction
  • Chronic kidney disease
🇺🇸
Approved in United States as Jardiance for:
  • Type 2 diabetes mellitus
  • Heart failure with reduced ejection fraction
  • Chronic kidney disease
  • Cardiovascular risk reduction
🇨🇦
Approved in Canada as Jardiance for:
  • Type 2 diabetes mellitus
  • Heart failure with reduced ejection fraction
  • Chronic kidney disease
🇯🇵
Approved in Japan as Jardiance for:
  • 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

Trials
275
Recruited
5,182,000+

University of Minnesota

Lead Sponsor

Trials
1,459
Recruited
1,623,000+

Findings from Research

Empagliflozin significantly reduces body mass index (BMI), liver stiffness measurement (LSM), aspartate aminotransferase (AST), and insulin resistance in patients with nonalcoholic fatty liver disease (NAFLD), based on a review of four randomized controlled trials involving 244 patients.
The findings suggest that empagliflozin improves liver health and metabolic parameters in NAFLD patients, indicating its potential as a new treatment option, although further research is needed to confirm its long-term efficacy and safety.
Efficacy and Safety of Empagliflozin on Nonalcoholic Fatty Liver Disease: A Systematic Review and Meta-Analysis.Zhang, Y., Liu, X., Zhang, H., et al.[2022]
In a 24-week trial involving 106 patients with non-alcoholic fatty liver disease (NAFLD) and type 2 diabetes (T2DM), empagliflozin showed a borderline significant reduction in liver fat content compared to placebo, indicating its potential efficacy in improving liver steatosis.
Empagliflozin also significantly reduced liver stiffness compared to pioglitazone, along with notable decreases in body weight and visceral fat, suggesting it may be a more effective treatment option for managing NAFLD in T2DM patients.
Empagliflozin Improves Liver Steatosis and Fibrosis in Patients with Non-Alcoholic Fatty Liver Disease and Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.Chehrehgosha, H., Sohrabi, MR., Ismail-Beigi, F., et al.[2021]
Empagliflozin treatment in a study of 7020 participants with type 2 diabetes and cardiovascular disease showed a slight reduction in liver fat (steatosis) risk, but did not significantly improve the risk of advanced liver fibrosis over time compared to placebo.
The benefits of empagliflozin on cardiorenal outcomes and overall mortality were consistent across different levels of liver fat and fibrosis risk, suggesting that its protective effects on heart and kidney health are independent of liver fat levels.
Effects of empagliflozin on markers of liver steatosis and fibrosis and their relationship to cardiorenal outcomes.Kahl, S., Ofstad, AP., Zinman, B., et al.[2022]

References

Efficacy and Safety of Empagliflozin on Nonalcoholic Fatty Liver Disease: A Systematic Review and Meta-Analysis. [2022]
Empagliflozin Improves Liver Steatosis and Fibrosis in Patients with Non-Alcoholic Fatty Liver Disease and Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. [2021]
Effects of empagliflozin on markers of liver steatosis and fibrosis and their relationship to cardiorenal outcomes. [2022]
Effect of Empagliflozin on Liver Steatosis and Fibrosis in Patients With Non-Alcoholic Fatty Liver Disease Without Diabetes: A Randomized, Double-Blind, Placebo-Controlled Trial. [2021]
Sodium-Glucose Cotransporter-2 Inhibitors for Treatment of Nonalcoholic Fatty Liver Disease: A Meta-Analysis of Randomized Controlled Trials. [2021]
Empagliflozin for the treatment of non-alcoholic fatty liver disease: a meta-analysis of randomized controlled trials. [2023]
Empagliflozin Effectively Lowers Liver Fat Content in Well-Controlled Type 2 Diabetes: A Randomized, Double-Blind, Phase 4, Placebo-Controlled Trial. [2020]
Empagliflozin (Jardiance): A Novel SGLT2 Inhibitor for the Treatment of Type-2 Diabetes. [2020]
Effect of Empagliflozin on Liver Fat in Patients With Type 2 Diabetes and Nonalcoholic Fatty Liver Disease: A Randomized Controlled Trial (E-LIFT Trial). [2022]
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