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SGLT2 Inhibitor

SGLT2 Inhibitors for Non-Alcoholic Fatty Liver Disease

Phase 2
Recruiting
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
Willingness to adhere to lifestyle considerations throughout the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 26 weeks
Awards & highlights

Study Summary

This trial is testing if a certain type of diabetes medication can help treat nonalcoholic fatty liver disease (NAFLD) in obese adolescents.

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.Check my eligibility
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.See study design
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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I am willing to follow specific lifestyle guidelines during the study.
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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 liver enzyme levels have been stable in recent tests.
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I have tried changing my lifestyle to treat obesity or fatty liver disease.
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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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy as Measured by Change in Hepatic Fat Fraction (HFF)
Secondary outcome measures
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%
Other
15%
Gastrointestinal
8%
Respiratory
8%
Worsening Heart Failure
3%
Angioedema
3%
S. Aureus Bacteremia
3%
Worsening Renal Function
3%
Acute Kidney Injury
3%
Syncope
100%
80%
60%
40%
20%
0%
Study treatment Arm
Empagliflozin
Placebo

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
~680

Find a Location

Who is running the clinical trial?

Ann & Robert H Lurie Children's Hospital of ChicagoLead Sponsor
253 Previous Clinical Trials
5,187,688 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease
2,250 Patients Enrolled for Non-alcoholic Fatty Liver Disease
University of MinnesotaLead Sponsor
1,371 Previous Clinical Trials
1,588,041 Total Patients Enrolled
2 Trials studying Non-alcoholic Fatty Liver Disease
66 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Justin Ryder, PhDPrincipal InvestigatorUniversity of Minnesota
2 Previous Clinical Trials
300 Total Patients Enrolled

Media Library

Empagliflozin (SGLT2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03867487 — Phase 2
Non-alcoholic Fatty Liver Disease Research Study Groups: Control arm, Study intervention
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: Empagliflozin Highlights & Side Effects. Trial Name: NCT03867487 — Phase 2
Empagliflozin (SGLT2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03867487 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has a trial of this kind ever been done before?

"At present, there are 49 active studies regarding Empagliflozin 10 MG being conducted in 43 countries and 237 cities. This drug was first trialled back in 2018 by Boehringer Ingelheim with 175 participants. Since then, a total of 338 trials have been completed; the latest one having reached its Phase 3 stage for official approval."

Answered by AI

Does this investigation permit the inclusion of seniors in its population?

"According to the eligibility criteria, individuals aged 12-17 can apply for this study. Currently, there are 40 studies focusing on minors and 378 research opportunities open to those over 65 years of age."

Answered by AI

Are there any openings available to join the clinical trial?

"Data on clinicaltrials.gov confirms that this study is actively recruiting participants, having first been posted in May of 2019 and edited most recently October 11th 2022."

Answered by AI

What clinical applications are associated with Empagliflozin 10 MG?

"Empagliflozin 10 MG is often prescribed to treat cardiovascular diseases, as well as specific issues like heart failure and type 2 diabetes mellitus. It may even help reduce the risk of cardiovascular mortality."

Answered by AI

Who is eligible to join this research endeavor?

"In order to be an eligible candidate for this research, a patient must have liver related pathologies and fall within the 12-17 year age bracket. A total of 40 participants are required for the trial to take place."

Answered by AI

How many subjects are currently included in this research endeavor?

"Correct. Records on clinicaltrials.gov demonstrate that this medical research, which was originally posted on May 1st 2019, is actively seeking participants. Approximately 40 individuals need to be recruited from a single site."

Answered by AI

Have any other investigations explored the efficacy of Empagliflozin 10 MG?

"Currently, 49 medical trials are underway examining Empagliflozin 10 MG. 13 of those active studies have reached Phase 3 clinical research standards. The main hub for this particular medication is located in Quilmes, Maryland; however, there are over a thousand locations running trials for it across the globe."

Answered by AI

Is Empagliflozin 10 MG a safe intervention for patients?

"Our assessment of Empagliflozin 10 MG's safety is 2, given the fact that this drug has only been tested in Phase 2 trials and there is no evidence to prove its efficacy."

Answered by AI
~1 spots leftby May 2024