Effects of Enavogliflozin on Coronary Microvascular and Cardiac Function in Obesity

NCT06782139 | Recruiting Phase 4

• 1 other identifier: 2024AN0301
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity and Type 2 Diabetes

Keywords

Sodium-Glucose Cotransporter 2 inhibitors; Obesity; Diabetes; Coronary microvascular function; Epicardial adipose tissue

Outcome Measures

Primary Outcomes (1)

• Coronary microvascular function

  The changes in coronary flow velocity reserve at 12 weeks compared to baseline in the active drug/placebo groups

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (16)

• Cardiopulmonary exercise capacity (VO2peak, mL/min/kg)

  From enrollment to the end of treatment at 12 weeks

• Body weight (kg)

  From enrollment to the end of treatment at 12 weeks

• Systolic and diastolic blood pressure (mmHg)

  From enrollment to the end of treatment at 12 weeks

• Waist circumference (cm)

  From enrollment to the end of treatment at 12 weeks

• Lipid profile

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

Enavogliflozin

EXPERIMENTAL

The medication is a soft, orange, bi-convex, triangular film-coated tablet, and it is administered once daily at a dose of 0.3 mg, regardless of meals.

Drug: Enavogliflozin

Placebo

PLACEBO COMPARATOR

The placebo is provided by the pharmaceutical company in the form of a tablet that is identical in size, shape, taste, and odor to the active intervention medication.

Drug: Placebo

Interventions

Enavogliflozin DRUG

Patients who are enrolled in the study will undergo adenosine stress tests assessing coronary flow velocity reserve and body composition analysis on the day of registration. Within 2 weeks, cardiopulmonary exercise tests will be performed with exhalation gas analysis. After completing the baseline cardiopulmonary exercise capacity evaluation, patients will be assigned to either the enavogliflozin or placebo group and monitored for adverse effects within one month. Patients without significant adverse effects will continue the assigned treatment, and at 12 weeks, they will undergo re-evaluation of coronary flow velocity reserve, body composition analysis, and cardiopulmonary exercise capacity. Adverse events will be monitored from the date of enrollment through the final evaluation.

Enavogliflozin

Placebo DRUG

Patients who are enrolled in the study will undergo adenosine stress tests assessing coronary flow velocity reserve and body composition analysis on the day of registration. Within 2 weeks, cardiopulmonary exercise tests will be performed with exhalation gas analysis. After completing the baseline cardiopulmonary exercise capacity evaluation, patients will be assigned to either the enavogliflozin or placebo group and monitored for adverse effects within one month. Patients without significant adverse effects will continue the assigned treatment, and at 12 weeks, they will undergo re-evaluation of coronary flow velocity reserve, body composition analysis, and cardiopulmonary exercise capacity. Adverse events will be monitored from the date of enrollment through the final evaluation.

Placebo

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).

You may not qualify 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 treadmill test, dobutamine stress echocardiography, myocardial perfusion imaging).
• 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.

Sponsors & Collaborators

• Korea University Anam Hospital: lead
• Daewoong Pharmaceutical Co. LTD.: collaborator

Study Sites (1)

Korea University Anam Hospital

Seoul, 02841, South Korea

RECRUITING

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Enavogliflozin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Seong-Mi Park, M.D., Ph.D.

  Korea University Anam Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

So Ree Kim, MD, PhD

CONTACT

82029205445; soree8826kim@gmail.com

Seong-Mi Park, M.D., Ph.D.

CONTACT

82029205445; smparkmd@korea.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: January 17, 2025
• Study Start: January 20, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)