Fatty Liver, NonalcoholicPhase 3NCT06117137
The Impact Of SGLT2 -I on Metabolic Dysfunction -Associated Steatotic Liver Disease In Patients With Type 2 Diabetes Mellitus
A Phase 3 study testing SGLT2 inhibitor in people with Fatty Liver, Nonalcoholic, run by Sohag University at 1 site in Egypt.
Trial summary
Study question 1:Could SGLT2-I improve hepatic fibrosis, steatosis, and inflammatory markers in type 2 diabetic patients with Metabolic associated steatotic liver disease Question 2:Which drug of SGLT2-I group is more effective in improving metabolic associated steatotic liver disease in type 2 diabetic patients? Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Fatty Liver, Nonalcoholic
- What is being tested?
- SGLT2 inhibitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2023to 3 Apr 2026
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women aged ≥20 years old who will be:
- Diagnosed with type 2 diabetes since ≥6 months in accordance with World Health Organization criteria (22); and
- Present with glycated hemoglobin equal to or greater than 7% and less than 10% after at least three months of treatment with metformin monotherapy at the maximal tolerated dosage or sulfonylurea alone or in combination; and
- Diagnosed with Metabolic associated steatotic liver disease
Who cannot join
- Diagnosis or signs of type 1 diabetes or non-diabetic patients
- Highly uncontrolled diabetes (HbA1c >86 mmol/mol [>10.0%])
- BMI ≥40 kg/m2
- Other causes of chronic hepatic steatosis (e.g., Hepatitis B virus ,Hepatitis c virus, autoimmune disease, Wilson disease, drugs, alpha one antitrypsin deficiency).
- Patients use of drugs known to cause hepatic steatosis (e.g., amiodarone, valproate, tamoxifen, methotrexate, steroids)
- Treatment with glucose-lowering drugs that influence liver fat, including thiazolidinediones, α-glucosidase inhibitors, sodium-glucose cotransporter 2 (SGLT2) inhibitors or any glucagon-like peptide-1 receptor agonists during the previous 3 months.
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- Detection of biliary duct obstruction based on imaging studies.
- Patients with diagnosis of or clinical features that are suspected for another systemic disease that commonly causes liver disease.
- Patient with history of liver transplantation
- Evidence of cirrhosis (on basis of ultrasonography and MRI) or hepatocellular carcinoma (evidence on triphasic CT or MRI).
- Positive HIV test
- Treatment with vitamin E during the previous 3 months.
- Intolerance or allergy SGLT2-I or any other substance in the tablets.
- Contraindications to SGLT2-I use (history of acute or chronic pancreatitis or pancreatic cancer, or history of recurrent urinary tract or genital infections, current or previous gangrene).
- History of or presence of (as found at Visit 1) any clinically significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the results or the patient's ability to participate in the study.
- Creatinine clearance <90 ml/min at screening (Cockcroft-Gault formula).
- Severe hepatic injury and/or significant abnormal liver function defined as aspartate aminotransferase >5× upper limit of normal (ULN) and/or alanine aminotransferase >5× ULN.
- Total bilirubin >2.0 mg/dl (34.2 μmol/l)\
- History of bariatric surgery or ongoing weight-loss diet (hypocaloric diet) or use of weight-loss agents unless the diet or treatment has been stopped at least 3 months before screening and that the patient has had a stable body weight (+/- 3 kg) during the 3 months before screening.
- Any clinically significant abnormalities in clinical chemistry, hematology or urinalysis results as judged by the investigator. This includes signs of liver disease other than non-alcoholic fatty liver disease that motivated further investigations or treatment based on clinical judgment.
- Drug abuse or alcohol abuse.
- Women who are pregnant, lactating or planning to become pregnant during the study period, or women of childbearing potential who are not using acceptable contraceptive methods. A woman is considered of childbearing potential if she is not surgically sterile or is less than 1 year since last menstrual period. Acceptable contraceptive methods will be combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progesterone-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion and vasectomized.
- Any other condition the investigator believed would interfere with the patient's ability to provide informed consent, comply with study instructions, or which might confound the interpretation of the study results or put the patient at undue risk.
- Any blood donation/blood loss >500 ml during the 3 months prior to Visit 1 or during the study.
- Patients with active malignancy
- Patients with established hemolytic disease
- Refused to consent to this study.
- The patient will be excluded from the study after the randomization if the second compound of combination therapy is inconsistent with the standard of medical care in diabetes -2022.
- Patient use of anti-inflammatory medications or corticosteroids during the observational period
- Missing the follow up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact Of Sodium-Glucose Cotransporter 2 Inhibitors on Metabolic Dysfunction -Associated Steatotic Liver Disease In Patients With Type 2 Diabetes Mellitus
Study question 1:Could SGLT2-I improve hepatic fibrosis, steatosis, and inflammatory markers in type 2 diabetic patients with Metabolic associated steatotic liver disease Question 2:Which drug of SGLT2-I group is more effective in improving metabolic associated steatotic liver disease in type 2 diabetic patients?
Read the detailed description
patients will be derived from Endocrine or Hepatology outpatient clinic and who were primarily visiting for management of type 2 diabetes and other comorbidities.
The effect of the SGLT2-I on metabolic associated steatotic liver disease patients with Type two diabetes mellitus will be a prospective, open-label, parallel-groups, randomized clinical study to examine the effect of different types of SGLT2-I (dapagliflozin, empagliflozin,) when included in the standard treatment of Type two diabetes mellitus versus standard treatment without SGLT2-I for 24 weeks based on a predefined computer-generated number with a 1:1 allocation that will be concealed in patients with Type 2 diabetes mellitus and Metabolic associated steatotic liver disease Patients will be treated with combination therapy metformin and/or sulfonylurea and/or dipeptidyl peptidase 4 (DPP-4) inhibitors and/or insulin (control group), for whom treatment with SGLT2-I plus standard treatment for type 2 diabetes. (SGLT2-I group) will be indicated due to poor diabetes control
- The patients will subsequently be classified and treated by the lines of diabetes therapy (based on randomization into SGLT2-I or control group).
Baseline assessment (First visit)
All patients before randomization will be subjected to :
Detailed medical history including:
Demographic characteristics, Medications for glycemic control Compliance on medications Duration of Diabetes and presence of any comorbidity Diabetes complications.
Detailed clinical examinations including:
Height, weight, waist circumference Systolic blood pressure and diastolic blood pressure. Body mass index (BMI) is calculated with division of weight (in kg) by square of height (in meters).
3 - Laboratory investigations: Plasma glucose level Glycated hemoglobin (HbA1c) Blood urea and serum creatinine, Serum uric acid, Total bilirubin (mg/dL) Alanine aminotransferase (units/L), Aspartate aminotransferase(units/L) Albumin (units/L) Total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglyceride, Plasma non-HDL-cholesterol was simply calculated by following formula: total cholesterol- HDL cholesterol.
Uric acid to cholesterol ratio is calculated with division of serum uric acid by HDL cholesterol.
The Uric acid to non-HDL cholesterol ratio is measured by the following formula: uric acid/non-HDL cholesterol.
Hepatitis B surface antigen, anti-hepatitis C and HIV I and II antibodies. Urine analysis and Albumin-to-creatinine ratio Complete blood counts Monocyte to high-density lipoprotein cholesterol ratio Neutrophil to lymphocyte ratio Platelet to lymphocyte ratio Lymphocyte to monocyte ratio Neutrophil-percentage-to-albumin ratio ECG 4-Other investigations will be including: Abdominal ultrasonography (Liver \& spleen size, portal vein diameter) 5- Non-Invasive Testing of Hepatic steatosis/fibrosis: Using vibration-controlled transient elastography (FibroScan), Study visits All participants will be instructed about potential adverse drug reactions. Each participant will be asked to document all the symptoms that they will experience during the study period, whether related to drug or not.
Compliance and adverse events will be assessed by a verbal questionnaire. In both groups, adjustment of diabetes treatment will be carried out based on self-monitored blood glucose at weeks 4 and 8 by telephone consultation.
All participants will be instructed to restrict simple carbohydrates (avoid simple sugars, reduce rice preparations) and fat intake (reduce butter, ghee).
All participants will be advised to exercise (brisk walk) for at least 45 min a day for at least 5 days a week.
Participants will return to the outpatient hepatology clinic for follow-up visits at weeks 12 and 24.
All the participants, at baseline and at week 12, will receive uniform lifestyle modification instructions in accordance with the standards of diabetes management Anthropometry, physical examination results and biochemical measurements will be recorded for each participant in week 24.
Biochemical measurements at follow-up
Venous blood samples will be taken at week 24 in the morning after participants had fasted overnight for 12 h and the samples will be analyzed on the same day at the center laboratory of the hospital for the previous variables.
Vibration controlled transient elastography (VCTE) parameters
Liver stiffness measurement (LSM) by VCTE (related to liver fibrosis) and controlled attenuation parameter (CAP; related to liver fat) will be measured using Fibroscan a trained hepatologist who will be blinded to the drug allocation, clinical data, and biomarker data.
Study group:
At the end of the study, all the patients will be classified according to Type of treatment Control group (stander treatment of Type 2 diabetes mellitus without SGLT2-I ) SGLT2-I groups (stander treatment of Type 2 diabetes mellitus plus SGLT2-I )
SGLT2-I group will be sub-grouped to Group dapagliflozin: stander treatment of Type 2 diabetes mellitus plus dapagliflozin Group empagliflozin: stander treatment of Type 2 diabetes mellitus plus empagliflozin
- Conditions
- Fatty Liver, Nonalcoholic
- Being tested
- SGLT2 inhibitor
- Keywords
- Sglt2-I, Metabolic associated steatotic liver disease, Type 2 diabetes mellitus
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGLT2 inhibitorDrug
Also called Empagliflozin ,Dapagliflozin
Group empagliflozin: stander treatment of type two diabetes mellitus plus empagliflozin
Group dapa:standard treatment of type 2 Diabetes mellitus and dapagliflozin
| Study group | Role | What they receive |
|---|---|---|
| Control group | Experimental | Control group (stander treatment of Type two diabetes mellitus without SGLT2-I ) Receives: Drug: SGLT2 inhibitor |
| Group dapa | Experimental | Dapa group: (stander treatment of type two diabetes mellitus plus Dapagliflozin) Receives: Drug: SGLT2 inhibitor |
| Group empa | Experimental | Group empagliflozin: stander treatment of type two diabetes mellitus plus empagliflozin Receives: Drug: SGLT2 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 6 months
Number of participants with tight controlled diabetes melitus
Measurement of glycated hemoglobin, random blood sugar,fasting blood sugar
Measured: 6 months
Secondary outcomes (3)
Number of participants with changing in liver stiffness measurement (LSM in kPa) measured by vibration-controlled transient elastography
Fibroscan before and after 6 months duration of treatment
Measured: 6 months
Number of participants with changing Liver and spleen size
Abdominal ultrasound
Measured: 6 months
Number of participant with changing in inflammatory biomarkers
Measurement of Monocyte to high-density lipoprotein cholesterol ratio Neutrophil to lymphocyte ratio Platelet to lymphocyte ratio Lymphocyte to monocyte ratio Neutrophil-percentage-to-albumin ratio
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start15 Nov 2023
- Primary completion1 Jan 2025
- Study completion3 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty Liver, NonalcoholicStudies of the same condition, open and under way.
- More trials run by Sohag 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Control group (stander treatment of Type 2 diabetes mellitus without SGLT2-I ) SGLT2-I groups (stander treatment of Type 2 diabetes mellitus plus SGLT2-I )
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George Esmat Roshdy, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06117137
- Sponsor's protocol ID
- Soh-Med-23-10-06MD
- Status last verified
- Apr 2026
- First submitted
- 19 Oct 2023
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact Of Sodium-Glucose Cotransporter 2 Inhibitors on Metabolic Dysfunction -Associated Steatotic Liver Disease In Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06117137
- Acronym / sponsor ID
- Soh-Med-23-10-06MD
- Conditions
- Fatty Liver, Nonalcoholic
- Keywords
- Sglt2-I, Metabolic associated steatotic liver disease, Type 2 diabetes mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 3 Apr 2026 (actual)
- First posted
- 3 Nov 2023 (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.
Study question 1:Could SGLT2-I improve hepatic fibrosis, steatosis, and inflammatory markers in type 2 diabetic patients with Metabolic associated steatotic liver disease Question 2:Which drug of SGLT2-I group is more effective in improving metabolic associated steatotic liver disease in type 2 diabetic patients?
Detailed description
patients will be derived from Endocrine or Hepatology outpatient clinic and who were primarily visiting for management of type 2 diabetes and other comorbidities.
The effect of the SGLT2-I on metabolic associated steatotic liver disease patients with Type two diabetes mellitus will be a prospective, open-label, parallel-groups, randomized clinical study to examine the effect of different types of SGLT2-I (dapagliflozin, empagliflozin,) when included in the standard treatment of Type two diabetes mellitus versus standard treatment without SGLT2-I for 24 weeks based on a predefined computer-generated number with a 1:1 allocation that will be concealed in patients with Type 2 diabetes mellitus and Metabolic associated steatotic liver disease Patients will be treated with combination therapy metformin and/or sulfonylurea and/or dipeptidyl peptidase 4 (DPP-4) inhibitors and/or insulin (control group), for whom treatment with SGLT2-I plus standard treatment for type 2 diabetes. (SGLT2-I group) will be indicated due to poor diabetes control
- The patients will subsequently be classified and treated by the lines of diabetes therapy (based on randomization into SGLT2-I or control group).
Baseline assessment (First visit)
All patients before randomization will be subjected to :
Detailed medical history including:
Demographic characteristics, Medications for glycemic control Compliance on medications Duration of Diabetes and presence of any comorbidity Diabetes complications.
Detailed clinical examinations including:
Height, weight, waist circumference Systolic blood pressure and diastolic blood pressure. Body mass index (BMI) is calculated with division of weight (in kg) by square of height (in meters).
3 - Laboratory investigations: Plasma glucose level Glycated hemoglobin (HbA1c) Blood urea and serum creatinine, Serum uric acid, Total bilirubin (mg/dL) Alanine aminotransferase (units/L), Aspartate aminotransferase(units/L) Albumin (units/L) Total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglyceride, Plasma non-HDL-cholesterol was simply calculated by following formula: total cholesterol- HDL cholesterol.
Uric acid to cholesterol ratio is calculated with division of serum uric acid by HDL cholesterol.
The Uric acid to non-HDL cholesterol ratio is measured by the following formula: uric acid/non-HDL cholesterol.
Hepatitis B surface antigen, anti-hepatitis C and HIV I and II antibodies. Urine analysis and Albumin-to-creatinine ratio Complete blood counts Monocyte to high-density lipoprotein cholesterol ratio Neutrophil to lymphocyte ratio Platelet to lymphocyte ratio Lymphocyte to monocyte ratio Neutrophil-percentage-to-albumin ratio ECG 4-Other investigations will be including: Abdominal ultrasonography (Liver \& spleen size, portal vein diameter) 5- Non-Invasive Testing of Hepatic steatosis/fibrosis: Using vibration-controlled transient elastography (FibroScan), Study visits All participants will be instructed about potential adverse drug reactions. Each participant will be asked to document all the symptoms that they will experience during the study period, whether related to drug or not.
Compliance and adverse events will be assessed by a verbal questionnaire. In both groups, adjustment of diabetes treatment will be carried out based on self-monitored blood glucose at weeks 4 and 8 by telephone consultation.
All participants will be instructed to restrict simple carbohydrates (avoid simple sugars, reduce rice preparations) and fat intake (reduce butter, ghee).
All participants will be advised to exercise (brisk walk) for at least 45 min a day for at least 5 days a week.
Participants will return to the outpatient hepatology clinic for follow-up visits at weeks 12 and 24.
All the participants, at baseline and at week 12, will receive uniform lifestyle modification instructions in accordance with the standards of diabetes management Anthropometry, physical examination results and biochemical measurements will be recorded for each participant in week 24.
Biochemical measurements at follow-up
Venous blood samples will be taken at week 24 in the morning after participants had fasted overnight for 12 h and the samples will be analyzed on the same day at the center laboratory of the hospital for the previous variables.
Vibration controlled transient elastography (VCTE) parameters
Liver stiffness measurement (LSM) by VCTE (related to liver fibrosis) and controlled attenuation parameter (CAP; related to liver fat) will be measured using Fibroscan a trained hepatologist who will be blinded to the drug allocation, clinical data, and biomarker data.
Study group:
At the end of the study, all the patients will be classified according to Type of treatment Control group (stander treatment of Type 2 diabetes mellitus without SGLT2-I ) SGLT2-I groups (stander treatment of Type 2 diabetes mellitus plus SGLT2-I )
SGLT2-I group will be sub-grouped to Group dapagliflozin: stander treatment of Type 2 diabetes mellitus plus dapagliflozin Group empagliflozin: stander treatment of Type 2 diabetes mellitus plus empagliflozin
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Control group (stander treatment of Type 2 diabetes mellitus without SGLT2-I ) SGLT2-I groups (stander treatment of Type 2 diabetes mellitus plus SGLT2-I )
| Arm | Type | Receives |
|---|---|---|
| Control group | Experimental | Drug: SGLT2 inhibitorControl group (stander treatment of Type two diabetes mellitus without SGLT2-I ) |
| Group dapa | Experimental | Drug: SGLT2 inhibitorDapa group: (stander treatment of type two diabetes mellitus plus Dapagliflozin) |
| Group empa | Experimental | Drug: SGLT2 inhibitorGroup empagliflozin: stander treatment of type two diabetes mellitus plus empagliflozin |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men or women aged ≥20 years old who will be:
Key exclusion criteria (30 listed)
- Diagnosis or signs of type 1 diabetes or non-diabetic patients
- Highly uncontrolled diabetes (HbA1c >86 mmol/mol [>10.0%])
- BMI ≥40 kg/m2
- Other causes of chronic hepatic steatosis (e.g., Hepatitis B virus ,Hepatitis c virus, autoimmune disease, Wilson disease, drugs, alpha one antitrypsin deficiency).
- Patients use of drugs known to cause hepatic steatosis (e.g., amiodarone, valproate, tamoxifen, methotrexate, steroids)
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 |
|---|---|---|
| SGLT2 inhibitorAlso: Empagliflozin ,DapagliflozinGroup empagliflozin: stander treatment of type two diabetes mellitus plus empagliflozin Group dapa:standard treatment of type 2 Diabetes mellitus and dapagliflozin | Drug | Control group, Group dapa, Group empa |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 6 months
Number of participants with tight controlled diabetes melitus
Time frame: 6 months
Measurement of glycated hemoglobin, random blood sugar,fasting blood sugar
3 secondary outcomes
Number of participants with changing in liver stiffness measurement (LSM in kPa) measured by vibration-controlled transient elastography
Time frame: 6 months
Number of participants with changing Liver and spleen size
Time frame: 6 months
Number of participant with changing in inflammatory biomarkers
Time frame: 6 months
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 7 Apr 2026.
- Individual participant dataSharing planned: No
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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 3 study testing SGLT2 inhibitor in people with Fatty Liver, Nonalcoholic, run by Sohag 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 4 inclusion and 30 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 7 Apr 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: 6 months). 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 7 Apr 2026.