Combining pioglitazone and empagliflozin for treating fatty liver disease in type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This exploratory study evaluates the effectiveness of using pioglitazone and empagliflozin together to improve liver and metabolic health in patients with type 2 diabetes and metabolic dysfunction-associated fatty liver disease (MAFLD). While both medications have shown benefits individually, this study aims to determine if their combined use leads to greater improvements in liver fat, inflammation, and fibrosis. Participants will receive either medication alone or in combination, and their progress will be monitored to assess the therapy's impact on liver health.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adults aged 20 years or older.
2. Patients with inadequately controlled type 2 diabetes mellitus, defined as HbA1c between 7% and 10%, who are currently treated with either:

   * Combination therapy of metformin and a sulfonylurea, or
   * Combination therapy of metformin and a DPP-4 inhibitor, or
   * Metformin monotherapy, or
   * Triple therapy (including metformin) provided that sulfonylurea will be discontinued upon study enrollment.
3. Evidence of hepatic steatosis within the past 3 months, confirmed by Fibroscan with a controlled attenuation parameter (CAP) ≥ 268 dB/m (consistent with S2 or greater \[≥10% hepatocyte steatosis\] according to the 2024 EASL-EASD-EASO guidelines).
4. Presence of at least one of the following metabolic abnormalities:

   * Waist circumference ≥90 cm for men or ≥85 cm for women.
   * Blood pressure ≥130 mmHg systolic or ≥85 mmHg diastolic, or use of antihypertensive medication.
   * Serum triglycerides ≥150 mg/dL or current use of lipid-lowering agents.
   * HDL-cholesterol ≤45 mg/dL for men or ≤50 mg/dL for women.
   * HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) ≥2.5.
   * Serum C-reactive protein (CRP) ≥2 mg/L.
5. No changes in anti-diabetic or metabolic medications within the past 3 months, unless the changes are deemed by the investigator not to affect study outcomes.

Exclusion Criteria:

1. Patients receiving insulin therapy or diagnosed with type 1 diabetes mellitus.
2. Use of the following medications within the past 3 months: GLP-1 receptor agonists, SGLT2 inhibitors, rosiglitazone (TZD), vitamin E, or ursodeoxycholic acid (UDCA).
3. Presence of secondary causes of hepatic steatosis unrelated to metabolic dysfunction, such as hepatitis B, hepatitis C, or alcoholic fatty liver disease.
4. Use of medications known to induce hepatic steatosis, including valproic acid, estrogen, tamoxifen, amiodarone, or chloroquine.
5. Severe organ failure, defined as:

   * Liver failure: AST or ALT \> 5 times the upper normal limit (UNL), serum albumin \< 3.2 g/dL, platelet count \< 60,000/µL, or Child-Pugh-Turcotte stage B or C.
   * Renal failure: Serum creatinine ≥ 2.0 mg/dL, estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m² (CKD-EPI formula), or patients with end-stage renal disease or on dialysis.
6. Presence of hepatocellular carcinoma, active malignancy, or metastatic cancer.
7. History of or active bladder cancer.
8. History of heart failure or current diagnosis of heart failure.
9. Presence of terminal illnesses.
10. History of gallstone disease, chronic pancreatitis, or acute pancreatitis.
11. Underweight patients (body mass index \[BMI\] \< 18.5 kg/m²).
12. Pregnant women or women planning to become pregnant.
13. Known hypersensitivity to the active ingredients or excipients of the study medications.
14. History of diabetic ketoacidosis.

Where it's running

• Seoul National University Bundang Hospital
  Seongnam-si, South Korea Recruiting

Study contacts

• Study coordinator: Soo Lim Dr, MD PhD
• Email: limsoo@snu.ac.kr
• Phone: +82-31-787-7035

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Acute Blood Flow Restriction Walking in Type 2 Diabetes

  This study tests whether adding blood flow restriction to treadmill walking affects immune cells in adults with type 2 diabetes.

  Recruiting University of British Columbia · Kelowna, British Columbia · NCT07928531

• Continuous Glucose Monitoring in Type 2 Diabetes Not on Insulin

  This study tests whether using a continuous glucose monitoring system helps people with type 2 diabetes who aren’t using insulin to improve blood sugar control and quality of life.

  Recruiting Medical University of Bialystok · Bialystok · NCT07919236

• Differentiating heart disease in autoimmune vs. type 2 diabetes

  This study tests whether adult-onset autoimmune diabetes (AID/LADA) and type 2 diabetes (T2D) differ in how diabetic heart disease develops, using advanced heart imaging in people with AID, T2D, and healthy controls.

  Recruiting University of Roma La Sapienza · Rome, Roma · NCT07911007

• Lifestyle Metabotype Study B: Understanding Personalized Glucose Responses

  This study tests how lifestyle, metabolism, and brain energy use relate to each person’s blood sugar response after meals, across people with and without prediabetes or type 2 diabetes.

  Recruiting at 2 sites German Institute of Human Nutrition · Berlin and 1 other locations · NCT07888257

• Lifestyle Metabotype Study: How Daily Habits Shape Blood Sugar

  This observational study tests whether personal lifestyle and biological factors can predict how a person’s blood sugar responds after meals.

  Recruiting German Institute of Human Nutrition · Potsdam, Potsdam-Rehbrücke · NCT07868601

• Switching to Zenagamtide From Tirzepatide in Adults With Overweight or Obesity With or Without Type 2 Diabetes

  This study tests whether adults who are overweight or have obesity (with or without type 2 diabetes) can switch from tirzepatide to a new treatment called zenagamtide to find a tolerable dose.

  Recruiting at 2 sites Phase 1 Novo Nordisk A/S · Glendale, California and 1 other locations · NCT07868354

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.