Actively Recruiting
Effects of ENavogliflozin on Coronary microVascular and Cardiac Function in Patients With obesitY (ENVY)
Led by Korea University Anam Hospital · Updated on 2025-09-02
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
K
Korea University Anam Hospital
Lead Sponsor
D
Daewoong Pharmaceutical Co. LTD.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Obesity is a growing health concern linked to heart problems such as heart failure with preserved ejection fraction and coronary microvascular dysfunction, which can increase the risk of angina, heart attacks, and heart failure. Researchers are evaluating how the drug enavogliflozin affects heart and microvascular function in obese patients, compared to a placebo. This study aims to better understand whether enavogliflozin can improve heart function and exercise capacity in these patients, especially since current treatments for microvascular issues often have limited success. Participants will take either enavogliflozin or a placebo tablet once daily for 12 weeks. Enavogliflozin is given as a soft, orange, triangular film-coated tablet at a dose of 0.3 mg, taken regardless of meals. Before starting treatment, patients will have tests including adenosine stress tests to measure coronary flow, body composition analysis, and cardiopulmonary exercise tests with gas analysis. After one month, those without serious side effects continue treatment, and at 12 weeks, these tests will be repeated to assess changes. During the study, participants will be closely monitored for side effects from the time of enrollment until the final evaluation. The main measurement is coronary microvascular function from the start to the end of treatment. Researchers will also assess exercise capacity, body weight, blood pressure, waist size, blood markers like lipid profile and hemoglobin A1c, heart ultrasound findings, muscle strength tests, and body composition. This detailed follow-up helps understand the drug's effects on heart and vascular health over the 12-week period.
CONDITIONS
Brief Title
Effects of Enavogliflozin on Coronary Microvascular and Cardiac Function in Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 20 and 79 years
- Body mass index (BMI) of 25 kg/m² or higher, or waist circumference of 90 cm or more for men, 85 cm or more for women
- Hemoglobin A1c of 6.5% or higher, or fasting blood glucose of 126 mg/dL or higher after 8 hours fasting, or currently on antidiabetic medication with blood test results within 3 months prior
- Have undergone coronary flow velocity reserve testing
- Baseline echocardiography available for evaluation of left ventricular diastolic dysfunction
You will not qualify if you...
- Left ventricular ejection fraction below 50%
- History of coronary artery disease or previous coronary artery interventions or bypass surgery
- Suspected obstructive coronary artery disease, including chest pain with positive stress tests
- Second-degree or higher atrioventricular block, symptomatic bradycardia, sick sinus syndrome, or Wolff-Parkinson-White syndrome
- Chronic kidney disease with GFR below 30 mL/min/1.73 m² or on dialysis
- Asthma, chronic obstructive pulmonary disease, or primary pulmonary hypertension
- Moderate or severe valvular or congenital heart disease, or history of open-heart surgery
- Active cancer within past 5 years or currently receiving chemotherapy
- Autoimmune vasculitis such as lupus or rheumatoid arthritis
- Unable to perform exercise testing like treadmill or bicycle ergometer
- Use of other SGLT2 inhibitors within past 6 months or known allergy to these drugs
- Pregnant or breastfeeding women
- Women planning pregnancy during the study or within 24 weeks from start
- Acute urinary tract infection at enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - 12 weeks
Participants will begin the assigned daily medication of enavogliflozin or placebo. During the first month, they will be monitored for any adverse effects. Treatment includes evaluations of coronary flow velocity reserve, body composition, and cardiopulmonary exercise capacity.
1 baseline visit and 1 follow-up visit at 12 weeks, plus monitoring visits during the first month
Trial Site Locations
Total: 1 location
1
Korea University Anam Hospital
Seoul, South Korea, 02841
Actively Recruiting
Research Team
S
So Ree Kim, MD, PhD
S
Seong-Mi Park, M.D., Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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