Metabolic-associated Fatty Liver DiseasePhase 4NCT05140694
Effect of Empagliflozin and Dulaglutide on MAFLD in Patients With T2D
A Phase 4 study testing Empagliflozin, Dulaglutide and Empagliflozin and Dulaglutide in people with Metabolic-associated Fatty Liver Disease and Type 2 Diabetes, run by Seoul National University Bundang Hospital.
Trial summary
The co-administration of SGLT2 inhibitor and GLP-1 receptor agonist would be safe and effective on glycemic control in subjects with type 2 diabetes mellitus and MAFLD better than empagliflozin or dulaglutide alone. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Metabolic-associated Fatty Liver Disease, Type 2 Diabetes
- What is being tested?
- Empagliflozin, Dulaglutide and Empagliflozin and Dulaglutide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 31 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 20 or over
- uncontrolled HbA1c (7~10%) with metformin and/or sulfonylurea
- Hepatic steatosis estimated by Fibroscan (CAP ≥258 dB/m)
- MAFLD: presence of any conditions
- Overweight or obese: BMI ≥23 kg/m2 (Asian)
- Metabolic dysregulation: at least of two of following criteria
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- Waist circumference: ≥90/80 cm in men and women (Asian)
- Blood pressure ≥130/85 mmHg or drug treatment
- Plasma triglycerides ≥150 mg/dL or drug treatment
- Plasma HDL-cholesterol <40/50 mg/dL for men and women or drug treatment
- Prediabetes (i.e. fasting glucose levels 100 to 125 mg/dL or 2-hour post-load glucose levels 140 to 199 mg/dL or HbA1c 5.7% to 6.4%
- HOMA-insulin resistance score ≥2.5
- Plasma high-sensitivity CRP >2 mg/L
Who cannot join
- Significant alcohol consumption
- Other competing causes for hepatic steatosis: viral hepatitis, drug-induced hepatitis, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha1 anti-trypsin deficiency, Celiac disease, Overt hypothyroidism, other secondary causes
- Type 1 diabetes mellitus
- medication usage within 3 months: vitamin E, PUFA, UDCA, fish oil, SGLT2 inhibitors, GLP1-RAs, TZDs
- Severe organ dysfunction
- liver damage: AST/ALT >x5 UNL, albumin <3.2, platelet <60k, Child-Pugh-Turcotte stage B or C
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- kidney damage: serum creatinine ≥2.0 mg/dL or eGFR <50 mL/min/1.72m2
- Hepatocellular carcinoma, active tumor, or metastasis
- End-stage liver disease
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized, Active-comparator Controlled, Parallel-group Study, to Evaluate the Effect of Empagliflozin and Dulaglutide on MAFLD in Patients With Type 2 Diabetes Mellitus
The co-administration of SGLT2 inhibitor and GLP-1 receptor agonist would be safe and effective on glycemic control in subjects with type 2 diabetes mellitus and MAFLD better than empagliflozin or dulaglutide alone.
The SGLT2 inhibitor and GLP-1 receptor agonist would be safe and effective on fatty liver disease in subjects with type 2 diabetes mellitus and MAFLD.
- Being tested
- Empagliflozin, Dulaglutide, Empagliflozin and Dulaglutide
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmpagliflozinDrug
Also called Jardiance
Empagliflozin 10 mg p.o. once daily (available to control over ~25mg)
DulaglutideDrug
Also called Trulicity
Dulaglutide 0.75mg s.c. once a week (available to control over ~1.5mg)
Empagliflozin and DulaglutideDrug
Also called Jardiance and Trulicity
Empagliflozin 10 mg p.o. once daily with Dulaglutide 0.75mg s.c. once weekly
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin | Experimental | Empagliflozin 10mg p.o. once daily (available to control over ~25mg) Receives: Drug: Empagliflozin |
| Dulaglutide | Experimental | Dulaglutide 0.75mg s.c. once weekly (available to control over ~1.5mg) Receives: Drug: Dulaglutide |
| Empagliflozin and Dulagludie | Experimental | Empagliflozin 10mg p.o. once daily and dulaglutide 0.75mg s.c. once weekly Receives: Drug: Empagliflozin and Dulaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of HbA1c level
Patients achieving the target level
Measured: baseline, week 12, week 24
Changes of CAP score
Controlled Attenuation Parameter (CAP) score by transient elastography
Measured: baseline, week 24
Secondary outcomes (9)
Changes of LSM score
Liver stiffness measurement (LSM) score by transient elastography
Measured: baseline, week 24
Changes of noninvasive liver fibrosis markers
Noninvasive liver fibrosis markers will be calculated at baseline and at the end of the study
Measured: baseline, week 12, week 24
Changes of body weight and body composition
Body composition by bioelectrical impedance will be measured at baseline and at the end of the study
Measured: baseline, week 24
Changes of lipid levels
Cholesterol level will be measured at all visit days
Measured: baseline, week 12, week 24
Changes of ketone levels
Ketone level will be measured at all visit days
Measured: baseline, week 12, week 24
Changes of liver parenchyma by ultrasonography
improvement or deterioration
Measured: baseline, week 24
Changes of liver function parameters
Liver enzymes, albumin will be measured at all visit days.
Measured: baseline, week 12, week 24
Changes of liver fibrosis biomarkers
Type IV collagen
Measured: baseline, week 24
Changes of inflammation biomarker
high-sensitivity CRP
Measured: baseline, week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start1 Dec 2023 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic-associated Fatty Liver DiseaseStudies 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
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo Lim, Seoul National University Bundang Hospital
- Investigators
- Soo Lim, MD, PhD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05140694
- Sponsor's protocol ID
- MAFLD_empa_dula
- Status last verified
- Oct 2022
- First submitted
- 26 Apr 2021
- Last updated
- 4 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Active-comparator Controlled, Parallel-group Study, to Evaluate the Effect of Empagliflozin and Dulaglutide on MAFLD in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05140694
- Acronym / sponsor ID
- MAFLD_empa_dula
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 Dec 2021 (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.
The co-administration of SGLT2 inhibitor and GLP-1 receptor agonist would be safe and effective on glycemic control in subjects with type 2 diabetes mellitus and MAFLD better than empagliflozin or dulaglutide alone.
The SGLT2 inhibitor and GLP-1 receptor agonist would be safe and effective on fatty liver disease in subjects with type 2 diabetes mellitus and MAFLD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin | Experimental | Drug: EmpagliflozinEmpagliflozin 10mg p.o. once daily (available to control over ~25mg) |
| Dulaglutide | Experimental | Drug: DulaglutideDulaglutide 0.75mg s.c. once weekly (available to control over ~1.5mg) |
| Empagliflozin and Dulagludie | Experimental | Drug: Empagliflozin and DulaglutideEmpagliflozin 10mg p.o. once daily and dulaglutide 0.75mg s.c. once weekly |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- age 20 or over
- uncontrolled HbA1c (7~10%) with metformin and/or sulfonylurea
- Hepatic steatosis estimated by Fibroscan (CAP ≥258 dB/m)
- MAFLD: presence of any conditions
Key exclusion criteria (9 listed)
- Significant alcohol consumption
- Other competing causes for hepatic steatosis: viral hepatitis, drug-induced hepatitis, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha1 anti-trypsin deficiency, Celiac disease, Overt hypothyroidism, other secondary causes
- Type 1 diabetes mellitus
- medication usage within 3 months: vitamin E, PUFA, UDCA, fish oil, SGLT2 inhibitors, GLP1-RAs, TZDs
- Severe organ dysfunction
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 |
|---|---|---|
| EmpagliflozinAlso: JardianceEmpagliflozin 10 mg p.o. once daily (available to control over ~25mg) | Drug | Empagliflozin |
| DulaglutideAlso: TrulicityDulaglutide 0.75mg s.c. once a week (available to control over ~1.5mg) | Drug | Dulaglutide |
| Empagliflozin and DulaglutideAlso: Jardiance and TrulicityEmpagliflozin 10 mg p.o. once daily with Dulaglutide 0.75mg s.c. once weekly | Drug | Empagliflozin and Dulagludie |
Primary outcome
Changes of HbA1c level
Time frame: baseline, week 12, week 24
Patients achieving the target level
Changes of CAP score
Time frame: baseline, week 24
Controlled Attenuation Parameter (CAP) score by transient elastography
9 secondary outcomes
Changes of LSM score
Time frame: baseline, week 24
Changes of noninvasive liver fibrosis markers
Time frame: baseline, week 12, week 24
Changes of body weight and body composition
Time frame: baseline, week 24
Changes of lipid levels
Time frame: baseline, week 12, week 24
Changes of ketone levels
Time frame: baseline, week 12, week 24
Changes of liver parenchyma by ultrasonography
Time frame: baseline, week 24
Changes of liver function parameters
Time frame: baseline, week 12, week 24
Changes of liver fibrosis biomarkers
Time frame: baseline, week 24
Changes of inflammation biomarker
Time frame: baseline, week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
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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. This study is not recruiting at the moment.
Soo Lim, MD, PhD principal investigator
Seoul National University Bundang Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Empagliflozin, Dulaglutide and Empagliflozin and Dulaglutide in people with Metabolic-associated Fatty Liver Disease and Type 2 Diabetes, run by Seoul National University Bundang Hospital.
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 13 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Soo Lim, 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?
Changes of HbA1c level (time frame: baseline, week 12, week 24). 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 4 Oct 2022.