MAFLD in Prediabetes and DiabetesPhase 4SGLT2NCT07891234
Effect of SGLT2 Inhibitor on Metabolic-Dysfunction-Associated Fatty Liver Disease in Patients With Insulin Resistance
A Phase 4 study testing Dapagliflozin 5Mg Tab, Metfomin 500 mg and Dapagliflozin (10mg Tab) in people with MAFLD in Prediabetes and Diabetes, run by Sherihan AboElyazed Mohamed Khalil at 1 site in Egypt.
Trial summary
Metabolic-dysfunction-associated fatty liver disease (MAFLD) has evolved as a major health problem recently. Discovering ways to prevent or delay the progression of MAFLD has become a global focus. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- MAFLD in Prediabetes and Diabetes
- What is being tested?
- Dapagliflozin 5Mg Tab, Metfomin 500 mg and Dapagliflozin (10mg Tab)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2026to 1 Oct 2027
- Phase
- Phase 4
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both sexes aged≥ 18 years
- Obese and non-obese patients
- Patients with prediabetes or type 2 diabetes
Who cannot join
- Patients with liver disease other than NAFLD
- Patients with type 1 diabetes
- pregnant patients
- Patients with malignancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
yvette iskandar, lecturer contact
Egypt1 site
Ain Shams University hospital
Cairo, 002
sherihan aboelyazed, dr.sherihan@med.asu.edu.eg
About this study
Official title: Effect of SGLT2 Inhibitor on Metabolic-Dysfunction Associated Fatty Liver Disease in Patients With Insulin Resistance
Metabolic-dysfunction-associated fatty liver disease (MAFLD) has evolved as a major health problem recently. Discovering ways to prevent or delay the progression of MAFLD has become a global focus. Lifestyle modifications remain the cornerstone of MAFLD treatment, even though various pharmaceutical interventions are currently under clinical trial. Among them, sodium-glucose co-transporter type-2 inhibitors (SGLT-2i) are emerging as promising agents.
In this study we aim to evaluate the effect of SGLT2 inhibitors on fatty liver disease in patients with prediabetes and type 2 diabetes
- Conditions
- MAFLD in Prediabetes and Diabetes
- Being tested
- Dapagliflozin 5Mg Tab, Metfomin 500 mg, Dapagliflozin (10mg Tab)
- Keywords
- MAFLD, SGLT2 inhibitors, prediabetes, type 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Prediabetic State, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 5Mg TabDrug
Also called PreDM/Dapa
Dapagliflozin 5 mg per os once daily will be used for the prediabetic group (1)
Metfomin 500 mgDrug
Also called PreDM/Met
Metformin 500 mg once daily after lunch will be used for the prediabetes group (2)
Dapagliflozin (10mg Tab)Drug
Also called DM/Dapa
Dapagliflozin 10 mg per os once daily will be used for diabetic patients not previously receiving SGLT2
| Study group | Role | What they receive |
|---|---|---|
| Prediabetic patients will receive SGLT2 inhibitors | Active comparator | Prediabetic patients with fatty liver disease will receive SGLT2 inhibitors (dapagliflozin) Receives: Drug: Dapagliflozin 5Mg Tab |
| Prediabetic patients will receive metformin | Active comparator | Prediabetic patients with fatty liver disease will receive metformin Receives: Drug: Metfomin 500 mg |
| Diabetic patients will receive SGLT2 inhibitors. | Active comparator | Diabetic patients with fatty liver disease will receive SGLT2 inhibitors (dapagliflozin). Receives: Drug: Dapagliflozin (10mg Tab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver fibrosis
Liver fibrosis will be evaluated using vibration-controlled transient elastography (VCTE) with controlled attenuation parameter (CAP) technology. We will measure liver stiffness (LSM) in kilopascals (kPa) using a FibroScan 502 Touch device equipped with both M and XL probes.
We will assess these parameter on day 0, then reassess after 3 months and 1 year.
Measured: one year
Liver steatosis
Liver steatosis will be evaluated using vibration-controlled transient elastography (VCTE) with controlled attenuation parameter (CAP) technology, using a FibroScan 502 Touch device equipped with both M and XL probes.
CAP in decibels per meter (dB/m). We will assess these parameter on day 0, then reassess after 3 months and 1 year.
Measured: one year
Fibrosis (FIB-4) score
FIB-4 score = (Age x AST) / (Platelets x √(ALT)) Will be assessed on day 0, then reassessed after 3 months and 1 year.
Measured: one year
NAFLD fibrosis score
NAFLD fibrosis score = -1.675 + (0.037 x age [years]) + (0.094 x BMI [kg/m²]) + (1.13 x IFG/diabetes [yes = 1, no = 0]) + (0.99 x AST/ALT ratio) - (0.013 x platelet count [×109/L]) - (0.66 x albumin [g/dl]).
Will be assessed on day 0, then reassessed after 3 months and 1 year.
Measured: one year
Secondary outcomes (5)
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
HOMA-IR: [fasting insulin (microU/L) x fasting glucose (mg/dL) / 405]. Will be assessed on day 0, then reassessed after 3 months and 1 year
Measured: one year
Glycated hemoglobin (HbA1C)
Glycated hemoglobin (HbA1c) will be measured on day 0, then followed up after 3 months and 1 year
Measured: one year
blood pressure control
Measurements of systolic and diastolic blood pressure (mmHg). Will be measured on day 0, then reassessed after 3 months and 1 year.
Measured: one year
lipid profile
Lipid profile (total cholesterol, LDL, triglycerides, HDL, and non-HDL). Will be assessed on day 0, then reassessed after 3 months and 1 year.
Measured: one year
Body mass index (BMI)
BMI = weight in kilograms/height in square meters. Will be assessed on day 0, then reassessed after 3 months and 1 year.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MAFLD in Prediabetes and DiabetesStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sherihan AboElyazed Mohamed Khalil
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams University
- Responsible party
- Sponsor-investigator, Sherihan AboElyazed Mohamed Khalil, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07891234
- Sponsor's protocol ID
- R40/2025
- Acronym
- SGLT2
- Status last verified
- Oct 2026
- First submitted
- 26 Sep 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhu X, Xia L, Yin D, Yang J, Wei R. Evaluating the Safety and Efficacy of Sodium-Glucose Co-transporter 2 Inhibitors in Subjects with Prediabetes: A Protocol for a Randomized Controlled Trial. Diabetes Ther. 2024 May;15(5):1231-1244. doi: 10.1007/s13300-024-01560-3. Epub 2024 Mar 18.
PubMed 38494571Androutsakos T, Nasiri-Ansari N, Bakasis AD, Kyrou I, Efstathopoulos E, Randeva HS, Kassi E. SGLT-2 Inhibitors in NAFLD: Expanding Their Role beyond Diabetes and Cardioprotection. Int J Mol Sci. 2022 Mar 13;23(6):3107. doi: 10.3390/ijms23063107.
PubMed 35328527Li L, Li Q, Huang W, Han Y, Tan H, An M, Xiang Q, Zhou R, Yang L, Cheng Y. Dapagliflozin Alleviates Hepatic Steatosis by Restoring Autophagy via the AMPK-mTOR Pathway. Front Pharmacol. 2021 May 17;12:589273. doi: 10.3389/fphar.2021.589273. eCollection 2021.
PubMed 34093169