Metabolic SyndromePhase 2NCT07336797
Effect of Empagliflozin on Metabolic Outcomes in Adults Living With HIV Receiving Dolutegravir-Based Therapy
A Phase 2 study testing Empagliflozin (oral) in people with Metabolic Syndrome and Obesity & Overweight, run by Abdelrahman Mahmoud at 1 site in Egypt.
Trial summary
We investigate the role of empagliflozin in the treatment of obesity in PLWH. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Metabolic Syndrome, Obesity & Overweight, HIV (Human Immunodeficiency Virus)
- What is being tested?
- Empagliflozin (oral)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2025to 30 Dec 2027
- Phase
- Phase 2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years up to 65 years old.
- Body Mass Index (BMI) > 30 kg/m^2.
- Currently receiving an integrase strand transfer inhibitor (INSTI)-based regimen (dolutegravir-based ART).
- Sustained virologic suppression, defined as HIV-1 RNA < 200 copies/mL for at least 6 months.
- Current CD4 count > 250 cells/mL.
- Ability and willingness to provide written informed consent.
Who cannot join
- Diagnosis of Diabetes Mellitus, defined as a fasting blood glucose level > 126 mg/dL or glycated hemoglobin (HbA1c) > 6.5% (or per ADA definition).
- Renal impairment (e.g., eGFR < 60 ml/min/1.73m^2).
- Active viral hepatitis B or C.
- Hypersensitivity to empagliflozin or any of its excipients.
- Pregnancy or breastfeeding.
- Current use of other SGLT-2 inhibitors.
Show all 9Show fewer
- Drugs that may interact with empagliflozin (e.g., rifampin or phenytoin) or dolutegravir (e.g., antacids, carbamazepine, or phenytoin).
- Current or recent use of medications known to be associated with significant weight gain (e.g., systemic corticosteroids, antipsychotics, mood stabilizers, or other agents with established weight-promoting effects).
- Known thyroid disease, defined as TSH > 6.0 mIU/L or < 0.35 mIU/L
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Pharmacy, Cairo University | Kasr El-Aini, Cairo
Cairo, 11562
Abdelrahman Dosoky, Bachelor's degree, +201148534951, abdalrahman.mahmoud@pharma.cu.edu.eg
Dosoky, abdalrahman.mahmoud@pharma.cu.edu.eg
About this study
Official title: Role of Empagliflozin in Metabolic Changes Associated With Antiretroviral Therapy in Human Immunodeficiency Virus
We investigate the role of empagliflozin in the treatment of obesity in PLWH.
Read the detailed description
HIV remains a major global public health concern. In 2024, approximately 40.8 million people were living with HIV worldwide. Around 630,000 deaths occurred due to AIDS-related illnesses. The preferred first-line ART regimen includes: Tenofovir disoproxil fumarate (TDF)+Emtricitabine (FTC) or Lamivudine (3TC)+Dolutegravir (DTG).
The introduction of highly active antiretroviral therapy transformed HIV from a fatal disease into a manageable chronic condition, significantly reducing morbidity and mortality.
Integrase strand transfer inhibitors (INSTIs), particularly dolutegravir (DTG), have been associated with greater weight gain compared with non-INSTI antiretroviral regimens.
The observed weight gain is strongly linked to adverse metabolic outcomes, including increased incidence of metabolic syndrome, higher rates of insulin resistance, and dyslipidemia.
Individuals living with HIV receiving antiretroviral therapy (ART) have been shown to have approximately 1.5-fold higher odds of developing metabolic syndrome (MetS).
Over the long term, these alterations contribute to a significantly elevated risk of cardiovascular disease, including myocardial infarction and stroke.
Evidence from biopsy-based studies further demonstrates a substantial burden of (NAFLD), (NASH), and liver fibrosis among people living with HIV (PLWH).
On the other hand, Sodium-glucose co-transporter-2 (SGLT2) inhibitors have demonstrated:
Cardiovascular benefits: Reduction in major adverse cardiovascular events in patients with atherosclerotic disease, including those with hypertension, dyslipidemia, and obesity.
Metabolic control: Improved glycemia via renal glucose reabsorption inhibition, lowering hyperglycemia with minimal hypoglycemic risk.
Weight and metabolic effects: Reduced body weight, BMI, SBP, visceral adiposity, insulin resistance, improved oral glucose tolerance test (OGTT) values and fasting insulin, even in non-diabetic individuals.
Hepatic outcomes: Significant reduction in liver fat content in metabolic disorders, mediated by improved lipid metabolism, insulin sensitivity, and reduced hepatic inflammation, supporting metabolic dysfunction-associated steatotic liver disease (MASLD) management.
These combined effects make SGLT2 inhibitors a promising therapeutic option for addressing the multiple facets of metabolic syndrome.
- Being tested
- Empagliflozin (oral), Placebo
- Keywords
- Obesity, Empagliflozin, PLWH, HIV, SGLT-2 inhibitor, Metabolic Syndrome, Weight
- Medical subject headings
- Metabolic Syndrome, Obesity, Overweight, Acquired Immunodeficiency Syndrome, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin (oral)Drug
Also called Mellitofix 10 mg
Empagliflozin is an oral medication used primarily to treat type 2 diabetes. It belongs to a class of drugs called SGLT2 inhibitors (sodium-glucose co-transporter 2 inhibitors). Empagliflozin blocks SGLT2 proteins in the kidneys.
This prevents glucose reabsorption, causing excess sugar to be excreted in urine.
It helps lower blood sugar levels and can also reduce body weight and blood pressure.
PlaceboDrug
Also called Group A, Inactive Substance
TDF/FTC+DLG
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Patients in the control group will receive an identical placebo and Standard Antiretroviral Therapy (ART) Receives: Drug: Placebo |
| EMPA Group + SOC | Experimental | Patients in the intervention arm will receive Empagliflozin 10 mg once daily for 6 months in addition to the standard DTG-based antiretroviral therapy. Receives: Drug: Empagliflozin (oral) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change
Weight will be measured in kilograms using a calibrated scale from baseline to 6 months in PLWH on dolutegravir-based antiretroviral therapy.
Measured: 6 months
Secondary outcomes (9)
Change in Total Cholesterol
Effects of empagliflozin versus placebo on Concentration of total cholesterol in serum, measured in mg/dL.
Measured: 6 months
Change in Fasting Blood Glucose
Concentration of glucose in blood plasma, measured in mg/dL after a minimum 8-hour overnight fast.
Measured: 6 months
Change in Glycated Hemoglobin (HbA1c)
The percentage of glycated hemoglobin in the blood, used as an indicator of long-term glycemic control.
Measured: 6 months
Change in Serum Creatinine
Concentration of creatinine in the blood, measured in mg/dL
Measured: 6 months
Change in Systolic and Diastolic Blood Pressure
Measured in millimeters of mercury (mmHg) while the participant is in a seated position. at baseline, 3 and 6 months.
Measured: 6 months
Change in Body Mass Index (BMI)
BMI is a calculation of body weight relative to height. It will be calculated as weight in kilograms divided by the square of height in meters (kg/m^2).
Measured: Baseline and 6 months
Change in Waist Circumference
Waist circumference will be measured using a non-stretchable flexible tape measure. The measurement will be taken at the midpoint between the lowest rib and the iliac crest (top of the hip bone) while the participant is standing and at the end of a normal expiration. Measurements will be recorded in centimeters.
Measured: Baseline, 3 and 6 months
Change in Absolute CD4+ T-cell Count
The absolute number of CD4+ T-lymphocytes will be measured in peripheral blood using flow cytometry. Results will be reported in cells per cubic millimeter (cells/mm³).
Measured: baseline and 6 months
Change in Plasma HIV-1 RNA Viral Load
Viral load will be quantified using a Real-Time Polymerase Chain Reaction (RT-PCR) assay. Results will be reported in copies per milliliter (copies/mL).
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start1 Sep 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a Phase II, single-center, parallel-group, randomized, double-blind, controlled study design. PWH will be recruited from the Cairo University HIV Clinic.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abdelrahman Mahmoud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Abdelrahman Mahmoud, Cairo University
- Investigators
- Maggie Abbassi, Prof., Study director, Cairo UniversityAbedalrahman Dosoky, Principal investigator, Cairo UniversityAhmed Kamel, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07336797
- Sponsor's protocol ID
- CL(3828)
- Status last verified
- Jan 2026
- First submitted
- 20 Nov 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Empagliflozin in Metabolic Changes Associated With Antiretroviral Therapy in Human Immunodeficiency Virus
- ClinicalTrials.gov ID
- NCT07336797
- Acronym / sponsor ID
- CL(3828)
- Keywords
- Obesity, Empagliflozin, PLWH, HIV, SGLT-2 inhibitor, Metabolic Syndrome, Weight
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Abdelrahman MahmoudUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 13 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.
We investigate the role of empagliflozin in the treatment of obesity in PLWH.
Detailed description
HIV remains a major global public health concern. In 2024, approximately 40.8 million people were living with HIV worldwide. Around 630,000 deaths occurred due to AIDS-related illnesses. The preferred first-line ART regimen includes: Tenofovir disoproxil fumarate (TDF)+Emtricitabine (FTC) or Lamivudine (3TC)+Dolutegravir (DTG).
The introduction of highly active antiretroviral therapy transformed HIV from a fatal disease into a manageable chronic condition, significantly reducing morbidity and mortality.
Integrase strand transfer inhibitors (INSTIs), particularly dolutegravir (DTG), have been associated with greater weight gain compared with non-INSTI antiretroviral regimens.
The observed weight gain is strongly linked to adverse metabolic outcomes, including increased incidence of metabolic syndrome, higher rates of insulin resistance, and dyslipidemia.
Individuals living with HIV receiving antiretroviral therapy (ART) have been shown to have approximately 1.5-fold higher odds of developing metabolic syndrome (MetS).
Over the long term, these alterations contribute to a significantly elevated risk of cardiovascular disease, including myocardial infarction and stroke.
Evidence from biopsy-based studies further demonstrates a substantial burden of (NAFLD), (NASH), and liver fibrosis among people living with HIV (PLWH).
On the other hand, Sodium-glucose co-transporter-2 (SGLT2) inhibitors have demonstrated:
Cardiovascular benefits: Reduction in major adverse cardiovascular events in patients with atherosclerotic disease, including those with hypertension, dyslipidemia, and obesity.
Metabolic control: Improved glycemia via renal glucose reabsorption inhibition, lowering hyperglycemia with minimal hypoglycemic risk.
Weight and metabolic effects: Reduced body weight, BMI, SBP, visceral adiposity, insulin resistance, improved oral glucose tolerance test (OGTT) values and fasting insulin, even in non-diabetic individuals.
Hepatic outcomes: Significant reduction in liver fat content in metabolic disorders, mediated by improved lipid metabolism, insulin sensitivity, and reduced hepatic inflammation, supporting metabolic dysfunction-associated steatotic liver disease (MASLD) management.
These combined effects make SGLT2 inhibitors a promising therapeutic option for addressing the multiple facets of metabolic syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This is a Phase II, single-center, parallel-group, randomized, double-blind, controlled study design. PWH will be recruited from the Cairo University HIV Clinic.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Drug: PlaceboPatients in the control group will receive an identical placebo and Standard Antiretroviral Therapy (ART) |
| EMPA Group + SOC | Experimental | Drug: Empagliflozin (oral)Patients in the intervention arm will receive Empagliflozin 10 mg once daily for 6 months in addition to the standard DTG-based antiretroviral therapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age >18 years up to 65 years old.
- Body Mass Index (BMI) > 30 kg/m^2.
- Currently receiving an integrase strand transfer inhibitor (INSTI)-based regimen (dolutegravir-based ART).
- Sustained virologic suppression, defined as HIV-1 RNA < 200 copies/mL for at least 6 months.
- Current CD4 count > 250 cells/mL.
Key exclusion criteria (9 listed)
- Diagnosis of Diabetes Mellitus, defined as a fasting blood glucose level > 126 mg/dL or glycated hemoglobin (HbA1c) > 6.5% (or per ADA definition).
- Renal impairment (e.g., eGFR < 60 ml/min/1.73m^2).
- Active viral hepatitis B or C.
- Hypersensitivity to empagliflozin or any of its excipients.
- Pregnancy or breastfeeding.
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 |
|---|---|---|
| Empagliflozin (oral)Also: Mellitofix 10 mgEmpagliflozin is an oral medication used primarily to treat type 2 diabetes. It belongs to a class of drugs called SGLT2 inhibitors (sodium-glucose co-transporter 2 inhibitors). Empagliflozin blocks SGLT2 proteins in the kidneys. This prevents glucose reabsorption, causing excess sugar to be excreted in urine. It helps lower blood sugar levels and can also reduce body weight and blood pressure. | Drug | EMPA Group + SOC |
| PlaceboAlso: Group A, Inactive SubstanceTDF/FTC+DLG | Drug | Control Group |
Primary outcome
Weight change
Time frame: 6 months
Weight will be measured in kilograms using a calibrated scale from baseline to 6 months in PLWH on dolutegravir-based antiretroviral therapy.
9 secondary outcomes
Change in Total Cholesterol
Time frame: 6 months
Change in Fasting Blood Glucose
Time frame: 6 months
Change in Glycated Hemoglobin (HbA1c)
Time frame: 6 months
Change in Serum Creatinine
Time frame: 6 months
Change in Systolic and Diastolic Blood Pressure
Time frame: 6 months
Change in Body Mass Index (BMI)
Time frame: Baseline and 6 months
Change in Waist Circumference
Time frame: Baseline, 3 and 6 months
Change in Absolute CD4+ T-cell Count
Time frame: baseline and 6 months
Change in Plasma HIV-1 RNA Viral Load
Time frame: baseline and 6 months
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 13 Jan 2026.
- Individual participant dataSharing planned: Yes
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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.
Maggie Abbassi, Prof. study director
Cairo University
Abedalrahman Dosoky principal investigator
Cairo University
Ahmed Kamel study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Empagliflozin (oral) in people with Metabolic Syndrome and Obesity & Overweight, run by Abdelrahman Mahmoud 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 6 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: looking for participants now, as of the sponsor's last update on 13 Jan 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Abdelrahman Dosoky, Bachelor's degree (+201148534951, abdelrahman.ibrahim@pharma.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight change (time frame: 6 months). 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 13 Jan 2026.