Empagliflozin for weight and metabolic changes in adults with HIV on dolutegravir
Tests empagliflozin against placebo for obesity in adults with HIV.
Plain-language title generated from the registry record
Registry title: Effect of Empagliflozin on Metabolic Outcomes in Adults Living With HIV Receiving Dolutegravir-Based Therapy
Key facts
- Where
- Cairo, EgyptSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults living with HIV who have obesity and take a dolutegravir-based treatment. It tests empagliflozin against a placebo for 6 months.
- Age
- Older than 18 years, up to 65 years.
- Sex
- All sexes can join.
- Disease stage
- BMI above 30 kg/m^2. HIV-1 RNA below 200 copies/mL for at least 6 months. CD4 count above 250 cells/mL.
- Earlier treatment
- Must currently take an integrase strand transfer inhibitor (INSTI)-based regimen (dolutegravir-based ART).
- Biomarker or test result
- HIV-1 RNA < 200 copies/mL for at least 6 months; CD4 count > 250 cells/mL.
Main reasons for not taking part
- Diabetes (fasting glucose > 126 mg/dL (7 mmol/L) or HbA1c > 6.5% (48 mmol/mol))
- Kidney impairment (eGFR < 60 ml/min/1.73m^2)
- Active hepatitis B or C
- Pregnancy or breastfeeding
- Thyroid disease (TSH > 6.0 mIU/L or < 0.35 mIU/L)
This trial only enrols participants living with HIV. The registry sentence this rests on: Sustained virologic suppression, defined as HIV-1 RNA < 200 copies/mL for at least 6 months.
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07336797, who can take part
Where in Egypt
- Faculty of Pharmacy, Cairo University | Kasr El-Aini, CairoCairo, EgyptTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Abdelrahman Mahmoud
- Trial code
- NCT07336797
- Record updated
- 13 January 2026
- Original description
We investigate the role of empagliflozin in the treatment of obesity in PLWH.Read full original descriptionShow less
Role of Empagliflozin in Metabolic Changes Associated With Antiretroviral Therapy in Human Immunodeficiency Virus
We investigate the role of empagliflozin in the treatment of obesity in PLWH.
Inclusion: 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: 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); 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; 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); Pregnancy or breastfeeding.