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New treatment option for Metabolic Syndrome
Official title Effect of Empagliflozin on Metabolic Outcomes in Adults Living With HIV Receiving Dolutegravir-Based Therapy
ClinicalTrials.gov ID: NCT07336797
What this study is testing
What is Empagliflozin (oral)?
Empagliflozin (oral) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for metabolic syndrome.
Also referred to as Mellitofix 10 mg.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- We investigate the role of empagliflozin in the treatment of obesity in PLWH.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Cairo, Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cairo, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.