RecruitingPhase 2NCT07336797

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

Sponsor

Abdelrahman Mahmoud

Enrollment

66 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

Metabolic Syndrome Obesity, Overweight HIV (Human Immunodeficiency Virus)

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether empagliflozin — a drug commonly used for type 2 diabetes and heart failure — can improve metabolic health (e.g., weight, blood sugar, and fat levels) in people living with HIV who are obese and taking a specific HIV treatment regimen (dolutegravir-based therapy). **You may be eligible if...** - You are between 18 and 65 years old - You have HIV and your viral load is undetectable (HIV RNA under 200 copies/mL for at least 6 months) - You have a BMI over 30 (classified as obese) - You are currently on a dolutegravir-based HIV treatment regimen - Your CD4 immune cell count is above 250 **You may NOT be eligible if...** - You have been diagnosed with diabetes - You have significant kidney disease - You have active hepatitis B or C - You are pregnant or breastfeeding - You are already taking another SGLT-2 inhibitor drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEmpagliflozin (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.

DRUGPlacebo

TDF/FTC+DLG