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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Metabolic Syndrome, Obesity & Overweight, HIV (Human Immunodeficiency Virus)

In brief

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

Key facts

Study ID

NCT07336797

Run by

Abdelrahman Mahmoud

People needed

66

Starts

2025-09-01

Expected to finish

2027-12-30

Last updated by the study team

2026-01-13

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Faculty of Pharmacy, Cairo University | Kasr El-Aini, Cairo — Cairo, Egypt (enrolling)

Full record on ClinicalTrials.gov

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