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Clinical Trials in Egypt / NCT07336797
Recruiting Phase 2

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

NCT07336797 · tracked via the Priya Life Science Egypt tracker
Sponsor
Abdelrahman Mahmoud
Phase
Phase 2
Started
2025-09-01
Last updated
2026-01-13

Condition(s) studied

Metabolic SyndromeObesity & OverweightHIV (Human Immunodeficiency Virus)

Investigational drug(s) / intervention(s)

Empagliflozin (oral) →Placebo

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)

Trial sites (1)

FacilityCityRegionStatus
Faculty of Pharmacy, Cairo University | Kasr El-Aini, Cairo Cairo Egypt Recruiting

More Abdelrahman Mahmoud trials in Egypt

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Official registry record

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.

View NCT07336797 on ClinicalTrials.gov ↗ ← All trials in Egypt