Clinical trial

Effect of Empagliflozin on Metabolic Outcomes in Adults Living With HIV Receiving Dolutegravir-Based Therapy

Recruiting now · Phase 2 · 1 countries · Registry ID NCT07336797

Recruiting nowPhase 2Interventional

What this study is about

We investigate the role of empagliflozin in the treatment of obesity in PLWH.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years
SexAll
Healthy volunteersNot accepted
ConditionMetabolic Syndrome, Obesity & Overweight, HIV (Human Immunodeficiency Virus)

Full registry criteria

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

Treatments and study arms

Empagliflozin (oral)

Drug

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

Drug

TDF/FTC+DLG

Primary outcomes

Weight change6 months

Weight will be measured in kilograms using a calibrated scale from baseline to 6 months in PLWH on dolutegravir-based antiretroviral therapy.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Faculty of Pharmacy, Cairo University | Kasr El-Aini, Cairo🇪🇬 Cairo, Egypt
Abdelrahman Dosoky, Bachelor's degreeContact
DosokyContact
Abdelrahman Dosoky, Bachelor's degPrincipal Investigator