NCT06782139 Effects of Enavogliflozin on Coronary Microvascular and Cardiac Function in Obesity
| NCT ID | NCT06782139 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Korea University Anam Hospital |
| Condition | Obesity and Type 2 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-01-20 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 30 participants in total. It began in 2025-01-20 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: The following criteria must be met for inclusion in the study: 1. Obesity or Abdominal Obesity: Body Mass Index (BMI) ≥ 25 kg/m², or Waist circumference: Male ≥ 90 cm, Female ≥ 85 cm. 2. 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 inclusion criteria: Age between 20 and 79 years. Patients who have undergone coronary flow velocity reserve testing. For baseline echocardiography, left ventricular diastolic dysfunction will be evaluated structurally (LV dimension, LV mass index, LA size) and hemodynamically (Doppler data, left ventricular ejection fraction, strain data). Exclusion Criteria: 1. Left ventricular ejection fraction (LVEF) \< 50% 2. History of coronary artery disease, or patients who have undergone coronary artery intervention or coronary artery bypass grafting. 3. 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 imaging). 4. Second-degree or higher atrioventricular block, symptomatic bradycardia, sick sinus syndrome, or Wolff-Parkinson-White syndrome. 5. Chronic kidney disease (GFR \< 30 mL/min/1.73 m²) or end-stage renal disease on hemodialysis or peritoneal dialysis. 6. Asthma, chronic obstructive pulmonary disease, or primary pulmonary hypertension. 7. Moderate or severe valvular heart disease or congenital heart disease, or patients with a history of open-heart surgery. 8. Active cancer within the last 5 years, or patients currently receiving chemotherapy. 9. Vasculitis associated with autoimmune diseases, such as systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA). 10. Patients who cannot undergo exercise testing, such as treadmill or bicycle ergometer testing. 11. Use of any other SGLT2 inhibitors (e.g., dapagliflozin, empagliflozin) within the past 6 months, or a known allergy to these drugs. 12. Pregnant or breastfeeding women. 13. Women planning pregnancy during the study period (or within 24 weeks from the start of the study, including the 12-week observation period). 14. Acute urinary tract infection at the time of enrollment.
Contact & Investigator
Seong-Mi Park, M.D., Ph.D.
PRINCIPAL INVESTIGATOR
Korea University Anam Hospital
Frequently Asked Questions
Who can join the NCT06782139 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 79 Years, studying Obesity and Type 2 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06782139 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06782139 currently recruiting?
Yes, NCT06782139 is actively recruiting participants. Contact the research team at soree8826kim@gmail.com for enrollment information.
Where is the NCT06782139 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT06782139 clinical trial?
NCT06782139 is sponsored by Korea University Anam Hospital. The principal investigator is Seong-Mi Park, M.D., Ph.D. at Korea University Anam Hospital. The trial plans to enroll 30 participants.
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