BridgeMD
New treatment option for Obesity and Type 2 Diabetes
Official title Effects of Enavogliflozin on Coronary Microvascular and Cardiac Function in Obesity
ClinicalTrials.gov ID: NCT06782139
What this study is testing
What is Enavogliflozin?
Enavogliflozin is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for obesity and type 2 diabetes.
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
- The goal of this study is to analyze the effects of enavogliflozin on heart function and coronary microvascular function in obese patients compared to a placebo, and to evaluate the improvement in cardiopulmonary exercise capacity in these patients.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 79
You may be able to join if
- The following criteria must be met for inclusion in the study:
- Obesity or Abdominal Obesity: Body Mass Index (BMI) ≥ 25 kg/m², or Waist circumference: Male ≥ 90 cm, Female ≥ 85 cm.
- Diabetes: Hemoglobin A1c ≥ 6.5%, or Fasting blood glucose ≥ 126 mg/dL after 8 hours of fasting, or Currently on antidiabetic medication. Blood test...
You likely can't join if
- Left ventricular ejection fraction (LVEF) \< 50%
- History of coronary artery disease, or patients who have undergone coronary artery intervention or coronary artery bypass grafting.
- Patients with suspected obstructive coronary artery disease, including those with chest pain and positive stress test results (e.g., exercise...
- Second-degree or higher atrioventricular block, symptomatic bradycardia, sick sinus syndrome, or Wolff-Parkinson-White syndrome.
- Chronic kidney disease (GFR \< 30 mL/min/1.73 m²) or end-stage renal disease on hemodialysis or peritoneal dialysis.
- Asthma, chronic obstructive pulmonary disease, or primary pulmonary hypertension.
See the full eligibility criteria
- The following criteria must be met for inclusion in the study:
- Obesity or Abdominal Obesity: Body Mass Index (BMI) ≥ 25 kg/m², or Waist circumference: Male ≥ 90 cm, Female ≥ 85 cm.
- Diabetes: Hemoglobin A1c ≥ 6.5%, or Fasting blood glucose ≥ 126 mg/dL after 8 hours of fasting, or Currently on antidiabetic medication. Blood test results must be within 3 months prior to enrollment. Other Age between...
- Left ventricular ejection fraction (LVEF) \< 50%
- History of coronary artery disease, or patients who have undergone coronary artery intervention or coronary artery bypass grafting.
- Patients with suspected obstructive coronary artery disease, including those with chest pain and positive stress test results (e.g., exercise treadmill test, dobutamine stress echocardiography, myocardial perfusion...
- Second-degree or higher atrioventricular block, symptomatic bradycardia, sick sinus syndrome, or Wolff-Parkinson-White syndrome.
- Chronic kidney disease (GFR \< 30 mL/min/1.73 m²) or end-stage renal disease on hemodialysis or peritoneal dialysis.
- Asthma, chronic obstructive pulmonary disease, or primary pulmonary hypertension.
- Moderate or severe valvular heart disease or congenital heart disease, or patients with a history of open-heart surgery.
- Active cancer within the last 5 years, or patients currently receiving chemotherapy.
- Vasculitis associated with autoimmune diseases, such as systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA).
- Patients who cannot undergo exercise testing, such as treadmill or bicycle ergometer testing.
- Use of any other SGLT2 inhibitors (e.g., dapagliflozin, empagliflozin) within the past 6 months, or a known allergy to these drugs.
- Pregnant or breastfeeding women.
- Women planning pregnancy during the study period (or within 24 weeks from the start of the study, including the 12-week observation period).
- Acute urinary tract infection at the time of enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
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, 20 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. 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.