Type 2 DiabetesPhase 4NCT06989723
Pioglitazone and Empagliflozin for Fatty Liver Disease in Type 2 Diabetes
A Phase 4 study testing Pioglitazone 15 MG [Actos], Empagliflozin 10 MG [Jardiance] and Empagliflozin 10 MG [Jardiance] + Pioglitazone 15 MG [Actos] in people with Type 2 Diabetes and Fatty Liver, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
This exploratory study will assess the efficacy of combined pioglitazone and empagliflozin therapy in improving hepatic and metabolic outcomes in patients with type 2 diabetes mellitus and metabolic dysfunction-associated fatty liver disease (MAFLD). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Type 2 Diabetes, Fatty Liver
- What is being tested?
- Pioglitazone 15 MG [Actos], Empagliflozin 10 MG [Jardiance] and Empagliflozin 10 MG [Jardiance] + Pioglitazone 15 MG [Actos]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2025to 30 Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 20 years or older.
- 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.
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- 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).
- 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.
- 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.
Who cannot join
- Patients receiving insulin therapy or diagnosed with type 1 diabetes mellitus.
- Use of the following medications within the past 3 months: GLP-1 receptor agonists, SGLT2 inhibitors, rosiglitazone (TZD), vitamin E, or ursodeoxycholic acid (UDCA).
- Presence of secondary causes of hepatic steatosis unrelated to metabolic dysfunction, such as hepatitis B, hepatitis C, or alcoholic fatty liver disease.
- Use of medications known to induce hepatic steatosis, including valproic acid, estrogen, tamoxifen, amiodarone, or chloroquine.
- 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.
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- 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.
- Presence of hepatocellular carcinoma, active malignancy, or metastatic cancer.
- History of or active bladder cancer.
- History of heart failure or current diagnosis of heart failure.
- Presence of terminal illnesses.
- History of gallstone disease, chronic pancreatitis, or acute pancreatitis.
- Underweight patients (body mass index [BMI] < 18.5 kg/m²).
- Pregnant women or women planning to become pregnant.
- Known hypersensitivity to the active ingredients or excipients of the study medications.
- History of diabetic ketoacidosis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Minji Sohn Dr, PhD contact
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si
Soo Lim Dr, +82-31-787-7035, limsoo@snu.ac.kr
About this study
Official title: Evaluation of Pioglitazone and Empagliflozin Combination Therapy in Type 2 Diabetes Patients With Metabolic Dysfunction-Associated Fatty Liver Disease
This exploratory study will assess the efficacy of combined pioglitazone and empagliflozin therapy in improving hepatic and metabolic outcomes in patients with type 2 diabetes mellitus and metabolic dysfunction-associated fatty liver disease (MAFLD). Although each agent has shown beneficial effects individually, evidence on their combined impact on liver health is scarce. This study seeks to determine whether the combination therapy yields additive improvements in hepatic steatosis, inflammation, and fibrosis, potentially offering a new therapeutic strategy for diabetic patients with fatty liver disease.
- Conditions
- Type 2 Diabetes, Fatty Liver
- Being tested
- Pioglitazone 15 MG [Actos], Empagliflozin 10 MG [Jardiance], Empagliflozin 10 MG [Jardiance] + Pioglitazone 15 MG [Actos]
- Medical subject headings
- Diabetes Mellitus, Type 2, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pioglitazone 15 MG [Actos]Drug
Participants will receive pioglitazone 15 mg, administered orally once daily. The tablet may be taken with or without food.
Empagliflozin 10 MG [Jardiance]Drug
Participants will receive empagliflozin 10 mg, administered orally once daily. The tablet may be taken with or without food.
Empagliflozin 10 MG [Jardiance] + Pioglitazone 15 MG [Actos]Drug
Participants will receive one tablet of pioglitazone 15 mg and one tablet of empagliflozin 10 mg, administered orally once daily. Both tablets may be taken with or without food.
| Study group | Role | What they receive |
|---|---|---|
| Pioglitazone | Experimental | Pioglitazone 15mg Receives: Drug: Empagliflozin 10 MG [Jardiance] |
| Empagliflozin | Experimental | Empagliflozin 10mg Receives: Drug: Pioglitazone 15 MG [Actos] |
| Pioglitazone & Empagliflozin | Experimental | Pioglitazone 15mg + Empagliflozin 10mg Receives: Drug: Empagliflozin 10 MG [Jardiance] + Pioglitazone 15 MG [Actos] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Achieving HbA1c Treatment Targets
Percentage of participants who achieve the predefined HbA1c treatment goal at 24 weeks.
Measured: 24 weeks
Change in Fibroscan Controlled Attenuation Parameter (CAP) Score
Assessment of changes in hepatic steatosis as measured by the controlled attenuation parameter (CAP) score using Fibroscan technology over a 24-week period.
Measured: 24 weeks
Secondary outcomes (8)
Change in HbA1c Levels
Change in glycated hemoglobin (HbA1c) from baseline after 24 weeks of treatment.
Measured: 24 weeks
Change in Liver Stiffness Measurement
Change in liver stiffness measurement (LSM) assessed using Fibroscan
Measured: 24 weeks
Change in Non-Invasive Blood-Based Fibrosis Markers
Change in NAFLD score, Fibrosis-4 (FIB-4) index, and AST to Platelet Ratio Index (APRI) over 12 and 24 weeks.
Measured: 12 weeks, 24 weeks
Change in Anthropometric Measures
Changes in metabolic parameters including body weight, body mass index (BMI), waist circumference
Measured: 12 weeks, 24 weeks
Change in Lipid Parameters
Changes in blood lipid profile (total cholesterol, LDL-c, HDL-c, triglycerides)
Measured: 12 weeks, 24 weeks
Change in Liver Function Tests
Change in liver function markers including AST, ALT, gamma-glutamyl transferase (gamma-GT), albumin, bilirubin, and prothrombin time
Measured: 12 weeks, 24 weeks
Change in Fibrosis Biomarker
Change in serum type IV collagen levels
Measured: 12 weeks, 24 weeks
Change in Inflammatory Biomarker
Change in high-sensitivity C-reactive protein (hs-CRP) levels
Measured: 12 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start1 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Celltrion
- Responsible party
- Principal investigator, Soo Lim, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06989723
- Sponsor's protocol ID
- B-2407-911-001
- Status last verified
- May 2025
- First submitted
- 29 Apr 2025
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pioglitazone and Empagliflozin Combination Therapy in Type 2 Diabetes Patients With Metabolic Dysfunction-Associated Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT06989723
- Acronym / sponsor ID
- B-2407-911-001
- Conditions
- Type 2 Diabetes, Fatty Liver
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- Celltrion
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This exploratory study will assess the efficacy of combined pioglitazone and empagliflozin therapy in improving hepatic and metabolic outcomes in patients with type 2 diabetes mellitus and metabolic dysfunction-associated fatty liver disease (MAFLD). Although each agent has shown beneficial effects individually, evidence on their combined impact on liver health is scarce. This study seeks to determine whether the combination therapy yields additive improvements in hepatic steatosis, inflammation, and fibrosis, potentially offering a new therapeutic strategy for diabetic patients with fatty liver disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pioglitazone | Experimental | Drug: Empagliflozin 10 MG [Jardiance]Pioglitazone 15mg |
| Empagliflozin | Experimental | Drug: Pioglitazone 15 MG [Actos]Empagliflozin 10mg |
| Pioglitazone & Empagliflozin | Experimental | Drug: Empagliflozin 10 MG [Jardiance] + Pioglitazone 15 MG [Actos]Pioglitazone 15mg + Empagliflozin 10mg |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Adults aged 20 years or older.
- Patients with inadequately controlled type 2 diabetes mellitus, defined as HbA1c between 7% and 10%, who are currently treated with either:
- 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).
- Presence of at least one of the following metabolic abnormalities:
- 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.
Key exclusion criteria (16 listed)
- Patients receiving insulin therapy or diagnosed with type 1 diabetes mellitus.
- Use of the following medications within the past 3 months: GLP-1 receptor agonists, SGLT2 inhibitors, rosiglitazone (TZD), vitamin E, or ursodeoxycholic acid (UDCA).
- Presence of secondary causes of hepatic steatosis unrelated to metabolic dysfunction, such as hepatitis B, hepatitis C, or alcoholic fatty liver disease.
- Use of medications known to induce hepatic steatosis, including valproic acid, estrogen, tamoxifen, amiodarone, or chloroquine.
- Severe organ failure, defined as:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pioglitazone 15 MG [Actos]Participants will receive pioglitazone 15 mg, administered orally once daily. The tablet may be taken with or without food. | Drug | Empagliflozin |
| Empagliflozin 10 MG [Jardiance]Participants will receive empagliflozin 10 mg, administered orally once daily. The tablet may be taken with or without food. | Drug | Pioglitazone |
| Empagliflozin 10 MG [Jardiance] + Pioglitazone 15 MG [Actos]Participants will receive one tablet of pioglitazone 15 mg and one tablet of empagliflozin 10 mg, administered orally once daily. Both tablets may be taken with or without food. | Drug | Pioglitazone & Empagliflozin |
Primary outcome
Proportion of Participants Achieving HbA1c Treatment Targets
Time frame: 24 weeks
Percentage of participants who achieve the predefined HbA1c treatment goal at 24 weeks.
Change in Fibroscan Controlled Attenuation Parameter (CAP) Score
Time frame: 24 weeks
Assessment of changes in hepatic steatosis as measured by the controlled attenuation parameter (CAP) score using Fibroscan technology over a 24-week period.
8 secondary outcomes
Change in HbA1c Levels
Time frame: 24 weeks
Change in Liver Stiffness Measurement
Time frame: 24 weeks
Change in Non-Invasive Blood-Based Fibrosis Markers
Time frame: 12 weeks, 24 weeks
Change in Anthropometric Measures
Time frame: 12 weeks, 24 weeks
Change in Lipid Parameters
Time frame: 12 weeks, 24 weeks
Change in Liver Function Tests
Time frame: 12 weeks, 24 weeks
Change in Fibrosis Biomarker
Time frame: 12 weeks, 24 weeks
Change in Inflammatory Biomarker
Time frame: 12 weeks, 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Minji Sohn Dr, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pioglitazone 15 MG [Actos], Empagliflozin 10 MG [Jardiance] and Empagliflozin 10 MG [Jardiance] + Pioglitazone 15 MG [Actos] in people with Type 2 Diabetes and Fatty Liver, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Soo Lim Dr, MD PhD (+82-31-787-7035, limsoo@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Achieving HbA1c Treatment Targets (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.