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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 4INTERVENTIONAL

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)

Effects of Enavogliflozin on Coronary Microvascular and Cardiac Function in Obesity (NCT06782139) is a Phase 4 interventional studying Obesity and Type 2 Diabetes, sponsored by Korea University Anam Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 30 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 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 Who May Qualify: 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). Who Should NOT Join This Trial: 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 conditions (where your immune system attacks your own body)s, such as systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA). ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Enavogliflozin

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.

DRUG

Placebo

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.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Korea University Anam Hospital
Seoul, South Korea

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06782139), the sponsor (Korea University Anam Hospital), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06782139 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06782139?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06782139?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06782139. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06782139. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.