NCT06782139RecruitingPhase 4
Effects of Enavogliflozin on Coronary Microvascular and Cardiac Function in Obesity
Effects of ENavogliflozin on Coronary microVascular and Cardiac Function in Patients With obesitY (ENVY)
Source: ClinicalTrials.gov · Last updated 2 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 9 Dec 2024
- Start date
- 20 Jan 2025
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Korea University Anam Hospital
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT06782139
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 30
- From 20 Jan 2025 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active cancer within the last 5 years, or patients currently receiving chemotherapy.
Other illness
- 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 imaging).
- Second-degree or higher atrioventricular block, symptomatic bradycardia, sick sinus syndrome, or Wolff-Parkinson-White syndrome.
- 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.
- Vasculitis associated with autoimmune diseases, such as systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA).
- Use of any other SGLT2 inhibitors (e.g., dapagliflozin, empagliflozin) within the past 6 months, or a known allergy to these drugs.
- Acute urinary tract infection at the time of enrollment.
Lab values
- Left ventricular ejection fraction (LVEF) \< 50%
- Chronic kidney disease (GFR \< 30 mL/min/1.73 m²) or end-stage renal disease on hemodialysis or peritoneal dialysis.
Other
- Patients who cannot undergo exercise testing, such as treadmill or bicycle ergometer testing.
- 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).
Who the study is looking for
- 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 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).
Age in the registry: 20 years to 79 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Korea University Anam Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.