Study of Enavogliflozins Effects on Heart and Blood Vessel Function in Adults with Obesity and Type 2 Diabetes

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 drugs effects on heart and vascular health over the 12-week period.

Effects of Enavogliflozin on Coronary Microvascular and Cardiac Function in Obesity