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

Sponsor
Abdelrahman Mahmoud
Study ID
NCT07336797
Phase
PHASE2
Status
Recruiting
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Conditions

  • HIV (Human Immunodeficiency Virus)
  • Metabolic Syndrome
  • Obesity & Overweight

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin (oral) — DRUG
    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.
  • Placebo — DRUG
    TDF/FTC+DLG

Study Details

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

Key Dates

Start date
Sep 1, 2025
Status verified
Jan 2026
Primary completion
Dec 30, 2026
Completion
Dec 30, 2027

Study Design

Enrollment
66 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Control Group
    Patients in the control group will receive an identical placebo and Standard Antiretroviral Therapy (ART)
  • Experimental: EMPA Group + SOC
    Patients in the intervention arm will receive Empagliflozin 10 mg once daily for 6 months in addition to the standard DTG-based antiretroviral therapy.

Primary Outcome Measure

Weight change [ Time Frame: 6 months ]

Central Contacts

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