NAFLD (Nonalcoholic Fatty Liver Disease)Phase 4(Dapa)& (Empa)NCT07363707
A Study Between Dapagliflozin and Empagliflozin Effect on NAFLD in Patients With Type 2 Diabetes.
A Phase 4 study testing Dapagliflozin + Metformin and Empa in people with NAFLD (Nonalcoholic Fatty Liver Disease), run by Beni-Suef University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to learn if drugs Dapagliflozin and Empagliflozin work to treat NAFLD in Type 2 diabetes patients. It will also learn about the safety of drugs dapagliflozin and empagliflozin. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- NAFLD (Nonalcoholic Fatty Liver Disease)
- What is being tested?
- Dapagliflozin + Metformin and Empa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to 1 Mar 2024
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults from 18 years old, male or female type 2 diabetic NAFLD patients.
Who cannot join
- People who have chronic liver disease,
- Hepatitis C virus (HCV) patients or those treated for HCV,
- History of autoimmune disease,
- Drugs that cause steatohepatitis
- and alcoholic patients will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study of the Effect of Dapagliflozin Versus Empagliflozin ,Added to Metformin, on NAFLD in Patients With Type 2 Diabetes
The goal of this clinical trial is to learn if drugs Dapagliflozin and Empagliflozin work to treat NAFLD in Type 2 diabetes patients. It will also learn about the safety of drugs dapagliflozin and empagliflozin. The main questions it aims to answer are:
Do drug dapagliflozin and empagliflozin lower the NAFLD degree for participants? What medical problems do participants have when taking the drugs dapagliflozin and empagliflozin?
Read more
Researchers will compare drug dapagliflozin to empagliflozin to see which of them more effective to treat NAFLD.
Participants will:
Take drug dapagliflozin or empaglifloin every day for 6 months Visit the clinic once every 2 weeks for checkups and tests Keep a diary of their symptoms and the number of times they use a rescue inhaler
Read the detailed description
Type 2 Diabetes Mellitus (T2DM) and Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) are two chronic, interconnected metabolic disorders that affect millions of individuals worldwide. MASLD is currently the most prevalent chronic liver disease, with a global burden of 17 % to 46% of chronic liver disease cases. Patients with DM2 have a very high prevalence of MASLD, which can vary from 40% to 60%. In clinical settings, MASLD has been reported to share similar pathophysiological mechanisms (such as insulin resistance, defective hepatic lipid profile, and abnormal triglyceride metabolism) with type 2 diabetes and is strongly associated with it . It has been revealed that MASLD increases the risk of type 2 diabetes incidents by approximately twofold. Therefore, reducing the prevalence of MASLD could help mitigate the impact of type 2 diabetes to some extent. SGLT2 inhibitors are promising for MASLD and T2DM because they improve glucose control, promote weight loss, and have direct beneficial effects on the liver, such as reducing liver fat and inflammation. So, Sodium-Glucose Transport Protein 2 (SGLT-2) inhibitors would be promising therapeutic agents for treatment of MASLD/ Nonalcoholic Steatohepatitis (NASH) patients. Therefore, great interest should be provided towards SGLT-2i treatment that contributes to alleviation of MASLD by reduction of hyperglycaemia, improvement of systematic insulin resistance, elevation of caloric loss and reduction of body weight mostly due to glycosuria.
The management of (T2DM) and (MASLD) involves a multifaceted approach that targets the underlying pathophysiology of both diseases. Management strategies typically focus on controlling blood glucose levels, improving insulin sensitivity, and addressing the hepatic fat accumulation and inflammation that characterize MASLD.(12) Nevertheless, animal and human studies on incretin mimetics, glucagon-like peptide-1 receptor agonists (GLP-1 RA) approved for T2DM treatment, have provided indirect evidence that they may also ameliorate progression of MASLD/NASH, over other antidiabetic types in T2DM patients with MASLD. Therefore, newer antidiabetic agents with an additive MASLD-lowering effect would be of great interest.
Sodium-glucose co-transporter 2 (SGLT-2) inhibitors are a promising oral treatment for T2D either as monotherapy or in combination with other antidiabetic agents. In addition to their anti-hyperglycemic effects and ability to reduce body weight, SGLT-2i seem to exert potent antioxidant and anti-inflammatory effects, making them promising candidates for MASLD treatment. SGLT2 inhibitors induce a series of modifications that have the potential to improve the liver condition in individuals with MASLD; they improve glycemic profile, reduce visceral adipose tissue, increase plasma adiponectin levels, and decrease uric acid levels; they also diminish oxidative stress and systemic inflammation and increase glucacon levels. Short and long-term follow-up studies should elucidate the role of these drugs in the prevention and attenuation of MASLD progression in early stages. The main aim of the present study is to compare the effects of two (SGLT-2)i , Dapa versus Empa, added to metformin) on liver steatosis and fibrosis for 6 monthsin patients with MASLD and T2D .
- Conditions
- NAFLD (Nonalcoholic Fatty Liver Disease)
- Being tested
- Dapagliflozin + Metformin, Empa
- Keywords
- Dapagliflozin and Empagliflozin
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin + MetforminDrug
name and concentration of drug ( Dapagliflozin 10 mg)
EmpaDrug
name and concentration of drug Empagliflozin 25
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin | Active comparator | Not described Receives: Drug: Dapagliflozin + Metformin |
| Empagliflozin | Active comparator | Not described Receives: Drug: Empa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibro scan, as well as the changes in FIB4 score and Full lipid profile (total cholesterol, LDL, HDL, VLDL, and triglyceride).
by using Fibro scan(Controlled Attenuation Parameter (CAP) The liver CAP score assesses fatty change (S1, S2, S3 grades), and Elasticity Score (E) kilopascals (kPa)) as well as the changes in FIB4 score (has no units; it's a calculated index (a number) derived from blood tests (AST, ALT, platelets) and age) and Full lipid profile (total cholesterol, LDL, HDL, VLDL and triglyceride (mg/dL) ) from baseline to six months in the two groups.
In a lipid profile, mg/dL stands for milligrams per deciliter. This is the standard unit of measurement used to express the concentration of cholesterol and fats in the blood.
What it Measures
The measurement indicates how many milligrams (mg) of a specific lipid are found in one deciliter (dL) of blood. A lipid profile typically reports several components using this unit:
Total Cholesterol: The overall amount of cholesterol (mg) in your blood(dl). LDL (Low-Density Lipoprotein) HDL (High-Density Lipoprotein) VLDLvery Low-Density Lipopr Triglycerides
Measured: at zero month and after 6 six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start1 May 2023
- Primary completion27 Aug 2023
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for NAFLD (Nonalcoholic Fatty Liver Disease)Studies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe 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
- Model description
- In this prospective randomized controlled trial, a number of 108 patients of MASLD and T2DM were enrolled into 2 equal groups to either receive Dapa 10mg /day(control group; n=54) or or Empa 25mg/day (n = 54), in addition to conventional therapy (metformin) for 6 months.
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Allah Emad ELdin Abdelazeem Abdelmotaleb, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07363707
- Sponsor's protocol ID
- effect of Dapa &Empa on NAFLD
- Acronym
- (Dapa)& (Empa)
- Status last verified
- Dec 2025
- First submitted
- 19 Dec 2025
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
11. Androutsakos T, Nasiri-Ansari N, Bakasis A-D, Kyrou I, Efstathopoulos E, Randeva HS, et al. SGLT-2 inhibitors in NAFLD: expanding their role beyond diabetes and cardioprotection. International journal of molecular sciences. 2022;23(6):3107. 12. Abdel-Rahman RF. Non-alcoholic fatty liver disease: epidemiology, pathophysiology and an update on the therapeutic approaches. Asian Pacific Journal of Tropical Biomedicine. 2022;12(3):99-114. 13. Athyros VG, Polyzos SA, Kountouras J, Katsiki N, Anagnostis P, Doumas M, et al. Non-Alcoholic Fatty Liver Disease Treatment in Patients with Type 2 Diabetes Mellitus; New Kids on the Block. Current vascular pharmacology. 2020;18(2):172-81. 14. Mohsen M, Elberry AA, Mohamed Rabea A, Abdelrahim ME, Hussein RR. Saxagliptin and vildagliptin lowered albuminuria in patients with diabetes and hypertension independent on glycaemic control. International Journal of Clinical Practice. 2021;75(3):e13769. 15. Xia C, Goud A, D'Souza J, Dahagam C, Rao X, Rajagopalan S, et al. DPP4 inhibitors and cardiovascular outcomes: safety on heart failure. Heart failure reviews. 2017;22:299-304. 16. Niezen S, Diaz del Castillo H, Mendez Castaner LA, Fornoni A. Safety and efficacy of antihyperglycaemic agents in diabetic kidney disease. Endocrinology, diabetes & metabolism. 2019;2(3):e00072. 17. Scheen A. Beneficial effects of SGLT2 inhibitors on fatty liver in type 2 diabetes: a common comorbidity associated with severe complications. Diabetes & metabolism. 2019;45(3):213-23. 18. Ciardullo S, Vergani M, Perseghin G. Nonalcoholic Fatty Liver Disease in Patients with Type 2 Diabetes: Screening, Diagnosis, and Treatment. Journal of Clinical Medicine. 2023;12(17):5597.
1. Bica C, Sandu C, Suceveanu AI, Sarbu E, Stoica RA, Gherghiceanu F, et al. Non-alcoholic fatty liver disease: A major challenge in type 2 diabetes mellitus. Experimental and Therapeutic Medicine. 2020;20(3):2387-91. 2. Das C, Tripathy D, Swain S, Sudhakaran N, Uthansingh K, Mallick P, et al. Effect of Dapa on type 2 diabetes mellitus with nonalcoholic fatty liver disease: a single-center survey. Cureus. 2021;13(5). 3. Almahmoud MH, Al Khawaja NM, Alkinani A, Khader Y, Ajlouni KM. Prevalence of fatty liver disease and its associated factors among Jordanian patients with type 2 diabetes mellitus: A cross-sectional study. Annals of Medicine and Surgery. 2021;68:102677. 4. Tanase DM, Gosav EM, Costea CF, Ciocoiu M, Lacatusu CM, Maranduca MA, et al. The intricate relationship between type 2 diabetes mellitus (T2DM), insulin resistance (IR), and nonalcoholic fatty liver disease (NAFLD). Journal of diabetes research. 2020;2020(1):3920196. 5. Targher G, Corey KE, Byrne CD, Roden M. The complex link between NAFLD and type 2 diabetes mellitus-mechanisms and treatments. Nature reviews Gastroenterology & hepatology. 2021;18(9):599-612. 6. Stefan N, Cusi K. A global view of the interplay between non-alcoholic fatty liver disease and diabetes. The lancet Diabetes & endocrinology. 2022;10(4):284-96. 7. Younossi ZM. Non-alcoholic fatty liver disease-a global public health perspective. Journal of hepatology. 2019;70(3):531-44. 8. Loomba R, Abraham M, Unalp A, Wilson L, Lavine J, Doo E, et al. Association between diabetes, family history of diabetes, and risk of nonalcoholic steatohepatitis and fibrosis. Hepatology. 2012;56(3):943-51. 9. Musso G, Gambino R, Cassader M, Pagano G. Meta-analysis: natural history of non-alcoholic fatty liver disease (NAFLD) and diagnostic accuracy of non-invasive tests for liver disease severity. Annals of medicine. 2011;43(8):617-49. 10. Popoviciu MS, Păduraru L, Rahman MM, Supti FA, Stoica RA, Reurean-Pintilei D, et al. The effects of SGLT2 inhibitor
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of the Effect of Dapagliflozin Versus Empagliflozin ,Added to Metformin, on NAFLD in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07363707
- Acronym / sponsor ID
- (Dapa)& (Empa) / effect of Dapa &Empa on NAFLD
- Conditions
- NAFLD (Nonalcoholic Fatty Liver Disease)
- Keywords
- Dapagliflozin and Empagliflozin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 27 Aug 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 23 Jan 2026 (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 goal of this clinical trial is to learn if drugs Dapagliflozin and Empagliflozin work to treat NAFLD in Type 2 diabetes patients. It will also learn about the safety of drugs dapagliflozin and empagliflozin. The main questions it aims to answer are:
Do drug dapagliflozin and empagliflozin lower the NAFLD degree for participants? What medical problems do participants have when taking the drugs dapagliflozin and empagliflozin?
Researchers will compare drug dapagliflozin to empagliflozin to see which of them more effective to treat NAFLD.
Participants will:
Take drug dapagliflozin or empaglifloin every day for 6 months Visit the clinic once every 2 weeks for checkups and tests Keep a diary of their symptoms and the number of times they use a rescue inhaler
Detailed description
Type 2 Diabetes Mellitus (T2DM) and Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) are two chronic, interconnected metabolic disorders that affect millions of individuals worldwide. MASLD is currently the most prevalent chronic liver disease, with a global burden of 17 % to 46% of chronic liver disease cases. Patients with DM2 have a very high prevalence of MASLD, which can vary from 40% to 60%. In clinical settings, MASLD has been reported to share similar pathophysiological mechanisms (such as insulin resistance, defective hepatic lipid profile, and abnormal triglyceride metabolism) with type 2 diabetes and is strongly associated with it . It has been revealed that MASLD increases the risk of type 2 diabetes incidents by approximately twofold. Therefore, reducing the prevalence of MASLD could help mitigate the impact of type 2 diabetes to some extent. SGLT2 inhibitors are promising for MASLD and T2DM because they improve glucose control, promote weight loss, and have direct beneficial effects on the liver, such as reducing liver fat and inflammation. So, Sodium-Glucose Transport Protein 2 (SGLT-2) inhibitors would be promising therapeutic agents for treatment of MASLD/ Nonalcoholic Steatohepatitis (NASH) patients. Therefore, great interest should be provided towards SGLT-2i treatment that contributes to alleviation of MASLD by reduction of hyperglycaemia, improvement of systematic insulin resistance, elevation of caloric loss and reduction of body weight mostly due to glycosuria.
The management of (T2DM) and (MASLD) involves a multifaceted approach that targets the underlying pathophysiology of both diseases. Management strategies typically focus on controlling blood glucose levels, improving insulin sensitivity, and addressing the hepatic fat accumulation and inflammation that characterize MASLD.(12) Nevertheless, animal and human studies on incretin mimetics, glucagon-like peptide-1 receptor agonists (GLP-1 RA) approved for T2DM treatment, have provided indirect evidence that they may also ameliorate progression of MASLD/NASH, over other antidiabetic types in T2DM patients with MASLD. Therefore, newer antidiabetic agents with an additive MASLD-lowering effect would be of great interest.
Sodium-glucose co-transporter 2 (SGLT-2) inhibitors are a promising oral treatment for T2D either as monotherapy or in combination with other antidiabetic agents. In addition to their anti-hyperglycemic effects and ability to reduce body weight, SGLT-2i seem to exert potent antioxidant and anti-inflammatory effects, making them promising candidates for MASLD treatment. SGLT2 inhibitors induce a series of modifications that have the potential to improve the liver condition in individuals with MASLD; they improve glycemic profile, reduce visceral adipose tissue, increase plasma adiponectin levels, and decrease uric acid levels; they also diminish oxidative stress and systemic inflammation and increase glucacon levels. Short and long-term follow-up studies should elucidate the role of these drugs in the prevention and attenuation of MASLD progression in early stages. The main aim of the present study is to compare the effects of two (SGLT-2)i , Dapa versus Empa, added to metformin) on liver steatosis and fibrosis for 6 monthsin patients with MASLD and T2D .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In this prospective randomized controlled trial, a number of 108 patients of MASLD and T2DM were enrolled into 2 equal groups to either receive Dapa 10mg /day(control group; n=54) or or Empa 25mg/day (n = 54), in addition to conventional therapy (metformin) for 6 months.
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin | Active comparator | Drug: Dapagliflozin + Metformin |
| Empagliflozin | Active comparator | Drug: Empa |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults from 18 years old, male or female type 2 diabetic NAFLD patients.
Key exclusion criteria (5 listed)
- People who have chronic liver disease,
- Hepatitis C virus (HCV) patients or those treated for HCV,
- History of autoimmune disease,
- Drugs that cause steatohepatitis
- and alcoholic patients will be excluded.
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 |
|---|---|---|
| Dapagliflozin + Metforminname and concentration of drug ( Dapagliflozin 10 mg) | Drug | Dapagliflozin |
| Empaname and concentration of drug Empagliflozin 25 | Drug | Empagliflozin |
Primary outcome
Fibro scan, as well as the changes in FIB4 score and Full lipid profile (total cholesterol, LDL, HDL, VLDL, and triglyceride).
Time frame: at zero month and after 6 six months
by using Fibro scan(Controlled Attenuation Parameter (CAP) The liver CAP score assesses fatty change (S1, S2, S3 grades), and Elasticity Score (E) kilopascals (kPa)) as well as the changes in FIB4 score (has no units; it's a calculated index (a number) derived from blood tests (AST, ALT, platelets) and age) and Full lipid profile (total cholesterol, LDL, HDL, VLDL and triglyceride (mg/dL) ) from baseline to six months in the two groups. In a lipid profile, mg/dL stands for milligrams per deciliter. This is the standard unit of measurement used to express the concentration of cholesterol and fats in the blood. What it Measures The measurement indicates how many milligrams (mg) of a specific lipid are found in one deciliter (dL) of blood. A lipid profile typically reports several components using this unit: Total Cholesterol: The overall amount of cholesterol (mg) in your blood(dl). LDL (Low-Density Lipoprotein) HDL (High-Density Lipoprotein) VLDLvery Low-Density Lipopr Triglycerides
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Background11. Androutsakos T, Nasiri-Ansari N, Bakasis A-D, Kyrou I, Efstathopoulos E, Randeva HS, et al. SGLT-2 inhibitors in NAFLD: expanding their role beyond diabetes and cardioprotection. International journal of molecular sciences. 2022;23(6):3107. 12. Abdel-Rahman RF. Non-alcoholic fatty liver disease: epidemiology, pathophysiology and an update on the therapeutic approaches. Asian Pacific Journal of Tropical Biomedicine. 2022;12(3):99-114. 13. Athyros VG, Polyzos SA, Kountouras J, Katsiki N, Anagnostis P, Doumas M, et al. Non-Alcoholic Fatty Liver Disease Treatment in Patients with Type 2 Diabetes Mellitus; New Kids on the Block. Current vascular pharmacology. 2020;18(2):172-81. 14. Mohsen M, Elberry AA, Mohamed Rabea A, Abdelrahim ME, Hussein RR. Saxagliptin and vildagliptin lowered albuminuria in patients with diabetes and hypertension independent on glycaemic control. International Journal of Clinical Practice. 2021;75(3):e13769. 15. Xia C, Goud A, D'Souza J, Dahagam C, Rao X, Rajagopalan S, et al. DPP4 inhibitors and cardiovascular outcomes: safety on heart failure. Heart failure reviews. 2017;22:299-304. 16. Niezen S, Diaz del Castillo H, Mendez Castaner LA, Fornoni A. Safety and efficacy of antihyperglycaemic agents in diabetic kidney disease. Endocrinology, diabetes & metabolism. 2019;2(3):e00072. 17. Scheen A. Beneficial effects of SGLT2 inhibitors on fatty liver in type 2 diabetes: a common comorbidity associated with severe complications. Diabetes & metabolism. 2019;45(3):213-23. 18. Ciardullo S, Vergani M, Perseghin G. Nonalcoholic Fatty Liver Disease in Patients with Type 2 Diabetes: Screening, Diagnosis, and Treatment. Journal of Clinical Medicine. 2023;12(17):5597.
- Background1. Bica C, Sandu C, Suceveanu AI, Sarbu E, Stoica RA, Gherghiceanu F, et al. Non-alcoholic fatty liver disease: A major challenge in type 2 diabetes mellitus. Experimental and Therapeutic Medicine. 2020;20(3):2387-91. 2. Das C, Tripathy D, Swain S, Sudhakaran N, Uthansingh K, Mallick P, et al. Effect of Dapa on type 2 diabetes mellitus with nonalcoholic fatty liver disease: a single-center survey. Cureus. 2021;13(5). 3. Almahmoud MH, Al Khawaja NM, Alkinani A, Khader Y, Ajlouni KM. Prevalence of fatty liver disease and its associated factors among Jordanian patients with type 2 diabetes mellitus: A cross-sectional study. Annals of Medicine and Surgery. 2021;68:102677. 4. Tanase DM, Gosav EM, Costea CF, Ciocoiu M, Lacatusu CM, Maranduca MA, et al. The intricate relationship between type 2 diabetes mellitus (T2DM), insulin resistance (IR), and nonalcoholic fatty liver disease (NAFLD). Journal of diabetes research. 2020;2020(1):3920196. 5. Targher G, Corey KE, Byrne CD, Roden M. The complex link between NAFLD and type 2 diabetes mellitus-mechanisms and treatments. Nature reviews Gastroenterology & hepatology. 2021;18(9):599-612. 6. Stefan N, Cusi K. A global view of the interplay between non-alcoholic fatty liver disease and diabetes. The lancet Diabetes & endocrinology. 2022;10(4):284-96. 7. Younossi ZM. Non-alcoholic fatty liver disease-a global public health perspective. Journal of hepatology. 2019;70(3):531-44. 8. Loomba R, Abraham M, Unalp A, Wilson L, Lavine J, Doo E, et al. Association between diabetes, family history of diabetes, and risk of nonalcoholic steatohepatitis and fibrosis. Hepatology. 2012;56(3):943-51. 9. Musso G, Gambino R, Cassader M, Pagano G. Meta-analysis: natural history of non-alcoholic fatty liver disease (NAFLD) and diagnostic accuracy of non-invasive tests for liver disease severity. Annals of medicine. 2011;43(8):617-49. 10. Popoviciu MS, Păduraru L, Rahman MM, Supti FA, Stoica RA, Reurean-Pintilei D, et al. The effects of SGLT2 inhibitor
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Dapagliflozin + Metformin and Empa in people with NAFLD (Nonalcoholic Fatty Liver Disease), run by Beni-Suef University at 1 site in Egypt.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 3 Feb 2026. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibro scan, as well as the changes in FIB4 score and Full lipid profile (total cholesterol, LDL, HDL, VLDL, and triglyceride). (time frame: at zero month and after 6 six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07363707, which also lists 2 linked publications.
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 3 Feb 2026.