Empagliflozin for metabolic health in adults with HIV on dolutegravir

Role of Empagliflozin in Metabolic Changes Associated With Antiretroviral Therapy in Human Immunodeficiency Virus

This trial tests whether the diabetes medicine empagliflozin can help reduce obesity-related metabolic problems in adults living with HIV who are taking dolutegravir-based antiretroviral therapy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Cairo University (Academic / other)
• Locations: 1 site (Cairo)
• Trial ID: NCT07336797 on ClinicalTrials.gov

What this trial studies

This phase 2 interventional trial compares empagliflozin versus placebo in adults with obesity (BMI >30 kg/m2) who are living with HIV and receiving dolutegravir-based ART. Eligible participants are aged 18–65, virologically suppressed (HIV-1 RNA <200 copies/mL) for at least 6 months with CD4 >250, and do not have diabetes, significant renal impairment, or active hepatitis. Participants will receive empagliflozin or placebo and undergo repeated metabolic assessments such as weight, measures of insulin resistance, lipid profiles, and liver-related markers over the treatment period. The trial aims to determine whether SGLT2 inhibition can mitigate dolutegravir-associated weight gain and related cardiometabolic disturbances.

Who should consider this trial

Good fit: Adults aged 18–65 with BMI >30 kg/m2 who are on a dolutegravir-based regimen, virologically suppressed (HIV-1 RNA <200 copies/mL) for ≥6 months, with CD4 >250 and adequate renal function, who can provide informed consent are the ideal candidates.

Not a fit: People with diagnosed diabetes, significant renal impairment (eGFR <60 ml/min/1.73 m2), active hepatitis B or C, pregnancy or breastfeeding, current use of other SGLT2 inhibitors, or taking interacting medications are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, empagliflozin could help reduce weight and improve insulin resistance, lipid levels, and liver fat in people with HIV on dolutegravir, potentially lowering long-term cardiovascular risk.

How similar studies have performed: SGLT2 inhibitors have shown cardiovascular and metabolic benefits in people without HIV, but their use specifically to address dolutegravir-associated weight gain in people living with HIV is not well established.

Eligibility 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

Where this trial is running

Cairo

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

Study contacts

• Principal investigator: Abedalrahman Dosoky — Cairo University
• Study coordinator: Abdelrahman Dosoky, Bachelor's degree

Conditions Metabolic Syndrome; Obesity & Overweight; HIV; Obesity; Empagliflozin; PLWH; SGLT-2 inhibitor; Weight