NCT07336797RecruitingPhase 2
Effect of Empagliflozin on Metabolic Outcomes in Adults Living With HIV Receiving Dolutegravir-Based Therapy
Role of Empagliflozin in Metabolic Changes Associated With Antiretroviral Therapy in Human Immunodeficiency Virus
Source: ClinicalTrials.gov · Last updated 13 Jan 2026
Brief summary (registry, in English)
We investigate the role of empagliflozin in the treatment of obesity in PLWH.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 66 (estimated)
- First submitted
- 20 Nov 2025
- Start date
- Sept 2025
- Primary completion date
- Dec 2026
- Lead sponsor
- Abdelrahman Mahmoud
- NCT number
- NCT07336797
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 66
- From Sept 2025 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- Active viral hepatitis B or C.
- Hypersensitivity to empagliflozin or any of its excipients.
- Known thyroid disease, defined as TSH \> 6.0 mIU/L or \< 0.35 mIU/L
Lab values
- 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).
Other
- Pregnancy or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Faculty of Pharmacy, Cairo University | Kasr El-Aini, Cairo Coordinator of this site? Confirm its status | Cairo | Egypt | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.