Empagliflozin for Fatty Liver
(SHIELD Trial)
Recruiting in Palo Alto (17 mi)
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Must not be taking: Weight loss meds, Vitamin E, Metformin, others
Disqualifiers: Diabetes, Major psychiatric disorder, others
Prior Safety Data
Trial Summary
What is the purpose of this trial?This study is a randomized, double-blind, placebo-controlled trial specifically designed to evaluate the preliminary feasibility, initial efficacy and safety of SGLT2 inhibitors for treating NAFLD in adolescents with obesity.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, such as weight loss medications, Vitamin E supplements, metformin, and any medications associated with weight gain, if you have used them recently. If you are on anti-hypertensive or lipid medications, you must have started them at least 3 months before enrolling.
What data supports the effectiveness of the drug empagliflozin for treating fatty liver?
Research shows that empagliflozin can reduce liver fat and improve liver health in people with non-alcoholic fatty liver disease (NAFLD) and type 2 diabetes. Studies found that it decreases liver fat content and improves markers of liver function and fibrosis (scarring).
12345Is empagliflozin safe for humans?
Empagliflozin has been studied in clinical trials for nonalcoholic fatty liver disease (NAFLD) and has shown a connection to improved liver health, suggesting it is generally safe for humans.
12678How does the drug empagliflozin differ from other treatments for fatty liver?
Empagliflozin is unique because it is primarily a diabetes medication that also helps reduce liver fat and improve liver health in people with fatty liver disease. Unlike some other treatments, it works by lowering blood sugar and reducing liver fat, which can also benefit heart and kidney health.
136910Eligibility Criteria
This trial is for obese adolescents with non-alcoholic fatty liver disease (NAFLD). Participants must be aged 16 to less than 21, have a BMI >30 or above the 95th percentile for their age, and show no signs of diabetes. They should have tried lifestyle changes to manage obesity or NAFLD and have elevated liver enzymes. Those with severe fluctuations in liver enzyme tests or other health issues are excluded.Inclusion Criteria
My BMI is over 30 or above the 95th percentile for my age.
My physical development is beyond the early stages of puberty.
My fasting blood sugar level is below 100 mg/dL.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive empagliflozin or placebo daily, 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
Participant Groups
The study is testing Empagliflozin, an SGLT2 inhibitor, against a placebo to see if it can help treat NAFLD in overweight teens. It's a randomized trial where neither the participants nor the researchers know who gets the real medicine versus a dummy pill.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Ann & Robert H Lurie Children's Hospital of ChicagoChicago, IL
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Who Is Running the Clinical Trial?
Ann & Robert H Lurie Children's Hospital of ChicagoLead Sponsor
References
Effects of empagliflozin on markers of liver steatosis and fibrosis and their relationship to cardiorenal outcomes. [2022]Empagliflozin treatment reduced liver fat in small type 2 diabetes cohorts. This post-hoc study evaluated effects of empagliflozin on risk for non-alcoholic fatty liver disease-related steatosis and fibrosis, as well as the relationship between risk categories and cardiorenal outcomes in the randomized, placebo-controlled EMPA-REG OUTCOME trial.
Efficacy and Safety of Empagliflozin on Nonalcoholic Fatty Liver Disease: A Systematic Review and Meta-Analysis. [2022]Clinical trials have recently shown a connection between nonalcoholic fatty liver disease (NAFLD) and empagliflozin. This paper aimed at comprehensively assessing the effectiveness and security of empagliflozin in NAFLD 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. [2021]To evaluate the efficacy of empagliflozin compared to pioglitazone in patients with non-alcoholic fatty liver disease (NAFLD) and type 2 diabetes (T2DM).
Long-term empagliflozin therapy improves levels of hepatic fibrosis marker in patients with non-alcoholic fatty liver disease complicated by type 2 diabetes mellitus. [2021]The long-term outcomes of patients with non-alcoholic fatty liver disease (NAFLD) treated with sodium-glucose cotransporter-2 inhibitors remain indeterminate. Empagliflozin improves hyperglycemia by increasing glucose excretion in the urine, and it reduces fat volume and insulin resistance. The aim of this study is to assess the effect of long-term empagliflozin therapy on hepatic inflammation, function and fibrosis in patients with NAFLD. This is a two-center retrospective observational study including patients with NAFLD complicated by type 2 diabetes mellitus. We retrospectively reviewed the medical records. Changes in parameters were investigated over one-year empagliflozin treatment. Twenty-four patients treated with empagliflozin were evaluated. Weight, body mass index, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transpeptidase, fasting plasma glucose, hemoglobin A1c, serum insulin and homeostasis model assessment insulin resistance significantly decreased during treatment (p
The Impact of an SGLT2 Inhibitor versus Ursodeoxycholic Acid on Liver Steatosis in Diabetic Patients. [2023]Non-alcoholic fatty liver disease (NAFLD) is related to metabolic syndrome via insulin resistance, where preventing disease progression is crucial in the management process. The study included 240 NAFLD patients with type 2 diabetes who were randomly allocated into empagliflozin 25 mg (EMPA group), ursodeoxycholic acid 250 mg (UDCA group), or the control group (placebo). The study outcomes included: changes in liver fat content (LFC; %) (utilizing the Dixon-based MRI-PDFF approach), liver enzymes, lipid and glycemic profiles, FIB-4 index, and non-alcoholic fatty liver score (NFS). All endpoints were assessed at baseline and after 6 months. EMPA outperformed UDCA and placebo in decreasing LFC (−8.73% vs. −5.71% vs. −1.99%; p
Effects of dapagliflozin in patients with nonalcoholic fatty liver disease: A systematic review and meta-analysis of randomized controlled trials. [2022]Dapagliflozin as a treatment option in patients with nonalcoholic fatty liver disease (NAFLD) has received increasing attention, however, the efficacy and safety of dapagliflozin for NAFLD has not been well assessed. This meta-analysis aimed to summarize these RCTs and evaluate the efficacy of dapagliflozin for patients with NAFLD.
Dapagliflozin for nonalcoholic fatty liver disease: A systematic review and meta-analysis. [2022]A few randomized controlled trials (RCTs) have assessed the use of dapagliflozin for the treatment of nonalcoholic fatty liver disease (NAFLD). A systematic review and meta-analysis was performed to investigate the efficacy and safety of dapagliflozin in adults with NAFLD.
Empaglifozin mitigates NAFLD in high-fat-fed mice by alleviating insulin resistance, lipogenesis and ER stress. [2020]To evaluate the pleiotropic effects of empagliflozin in the liver through lipogenesis, beta-oxidation, and endoplasmic reticulum stress pathways.
Empagliflozin Effectively Lowers Liver Fat Content in Well-Controlled Type 2 Diabetes: A Randomized, Double-Blind, Phase 4, Placebo-Controlled Trial. [2020]To evaluate whether the sodium-glucose cotransporter 2 inhibitor empagliflozin (EMPA) reduces liver fat content (LFC) in recent-onset and metabolically well-controlled type 2 diabetes (T2D).
Effects of a Combination of Empagliflozin Plus Metformin vs. Metformin Monotherapy on NAFLD Progression in Type 2 Diabetes: The IMAGIN Pilot Study. [2023]Non-alcoholic fatty liver disease (NAFLD) comprises a heterogeneous group of metabolic liver diseases and is characterized by the presence of steatosis in at least 5% of hepatocytes. The aim of our study was to assess the effect of the combination therapy of empagliflozin + metformin vs. metformin monotherapy on NAFLD progression in type 2 diabetic (T2DM) patients. Sixty-three metformin-treated T2DM patients who were SGLT2i-naïve and had an ultrasound diagnosis of NAFLD (aged 60.95 ± 11.14 years; males, 57.1%) were included in the present analysis. Thirty-three started the combination therapy. All patients were observed for 6 months and routinely monitored with anthropometry, blood biochemistry, and FibroScan®/CAP. At the 6-month follow-up, the combination therapy group presented a significant reduction in BMI (30.83 ± 3.5 vs. 28.48 ± 3.25), glycated hemoglobin (8.2 (7.4-8.8)) vs. 7.2 (6.8-7.9), ALT (68.5 (41.5-88.0) vs. 45.00 (38.00, 48.00)), CAP parameter (293.5 (270.0-319.25) vs. 267.00 (259.50, 283.75)) and steatosis degree (p = 0.001) in comparison with the control group, whose parameters remained almost stable over time. In patients affected by T2DM, the combination of empagliflozin + metformin vs. metformin monotherapy ameliorated liver steatosis, ALT levels, body weight, and glycated hemoglobin after a 6-month follow-up.