Empagliflozin (oral): 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.
Placebo: TDF/FTC+DLG
Study summary
We investigate the role of empagliflozin in the treatment of obesity in PLWH.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
* 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
Primary outcome measure(s)
Weight change — 6 months Weight will be measured in kilograms using a calibrated scale from baseline to 6 months in PLWH on dolutegravir-based antiretroviral therapy.
Trial sites (1)
Facility
City
Region
Status
Faculty of Pharmacy, Cairo University | Kasr El-Aini, Cairo
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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