Obesity and Type 2 DiabetesPhase 4ENVYNCT06782139
Effects of Enavogliflozin on Coronary Microvascular and Cardiac Function in Obesity
A Phase 4 study testing Enavogliflozin in people with Obesity and Type 2 Diabetes, run by Korea University Anam Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Obesity and Type 2 Diabetes
- What is being tested?
- Enavogliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Jan 2025to 31 Dec 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Korea University Anam Hospital
Seoul, 02841
So Ree Kim, MD, PhD, 82029205445, soree8826kim@gmail.com
So Ree Kim, MD, PhD
About this study
Official title: Effects of ENavogliflozin on Coronary microVascular and Cardiac Function in Patients With obesitY (ENVY)
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.
Read the detailed description
In recent years, the prevalence of obesity has increased, which acts as a significant risk factor for cardiovascular diseases. Obesity is closely related to reduced microvascular function, increased insulin resistance, and elevated blood pressure, and it is particularly known to be a major cause of heart failure with preserved ejection fraction (HFpEF) and diastolic dysfunction. Coronary microvascular dysfunction (CMD) leads to angina, myocardial infarction, and heart failure, which are associated with increased mortality. CMD has recently gained more importance as one of the key mechanisms of HFpEF. However, CMD often shows poor response to standard treatments, and when not recognized by healthcare providers, it can result in poor outcomes due to a lack of appropriate treatment.
Sodium-Glucose Cotransporter 2 (SGLT2) inhibitors are drugs that inhibit glucose reabsorption by blocking SGLT2 in the proximal tubules of the kidneys, thereby lowering blood sugar. Initially developed as oral hypoglycemic agents, previous randomized controlled studies have shown that they also have significant beneficial effects on heart failure and cardiovascular diseases not only in diabetic patients but also in non-diabetic patients. Recent studies have also demonstrated the effectiveness of SGLT2 inhibitors in patients with HFpEF. SGLT2 inhibitors reduce excessive sodium excretion through urine, which reduces fluid volume, lowers blood pressure, and decreases body weight, but the exact mechanism of their significant effects in cardiovascular diseases is still not fully understood. In particular, research on the effects of SGLT2 inhibitors on microvascular function is still limited. Recently, a randomized controlled study involving 16 diabetic patients reported an increase in myocardial flow reserve after 4 weeks of dapagliflozin administration, while another study involving 90 high-risk cardiovascular diabetic patients showed no significant change in myocardial flow reserve at 13 weeks with empagliflozin. Regarding enavogliflozin, a recent animal study in pigs suggested that it could improve vascular function by intervening in coronary endothelial cell function.
This study hypothesized that enavogliflozin would improve microvascular abnormalities and enhance heart function and cardiopulmonary exercise capacity in obesity-related cardiovascular diseases. Therefore, the objective of this study is to analyze the effects of enavogliflozin on heart function and 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
- Being tested
- Enavogliflozin, Placebo
- Keywords
- Sodium-Glucose Cotransporter 2 inhibitors, Obesity, Diabetes, Coronary microvascular function, Epicardial adipose tissue
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnavogliflozinDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary microvascular function
The changes in coronary flow velocity reserve at 12 weeks compared to baseline in the active drug/placebo groups
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (16)
Cardiopulmonary exercise capacity (VO2peak, mL/min/kg)
The changes in cardiopulmonary exercise capacity ((VO2peak, mL/min/kg) at 12 weeks compared to baseline in the active drug/placebo groups
Measured: From enrollment to the end of treatment at 12 weeks
Body weight (kg)
Changes in body weight (kg) at 12 weeks compared to baseline
Measured: From enrollment to the end of treatment at 12 weeks
Systolic and diastolic blood pressure (mmHg)
Changes in Systolic and diastolic blood pressure (mmHg) at 12 weeks compared to baseline
Measured: From enrollment to the end of treatment at 12 weeks
Waist circumference (cm)
Changes in waist circumference (cm) at 12 weeks compared to baseline
Measured: From enrollment to the end of treatment at 12 weeks
Lipid profile
Changes in total cholesterol (mg/dL), triglycerides (mg/dL), high-density lipoprotein cholesterol (mg/dL), and low-density lipoprotein cholesterol (mg/dL) at 12 weeks compared to baseline
Measured: From enrollment to the end of treatment at 12 weeks
Hemoglobin A1c (%)
Changes in hemoglobin A1c (%) at 12 weeks compared to baseline
Measured: From enrollment to the end of treatment at 12 weeks
NT-proBNP (pg/mL)
Changes in NT-proBNP (pg/mL) at 12 weeks compared to baseline
Measured: From enrollment to the end of treatment at 12 weeks
Self-assessment of sarcopenia (score)
Changes in self-assessment of sarcopenia (score) at 12 weeks compared to baseline
Measured: From enrollment to the end of treatment at 12 weeks
5-time chair rise test (sec)
Changes in 5-time chair rise test (sec) at 12 weeks compared to baseline
Measured: From enrollment to the end of treatment at 12 weeks
Body composition analysis - skeletal muscle mass index
Changes in skeletal muscle mass index (kg/m2) at 12 weeks compared to baseline
Measured: From enrollment to the end of treatment at 12 weeks
Body composition analysis - visceral fat area
Changes in visceral fat area (cm2) at 12 weeks compared to baseline
Measured: From enrollment to the end of treatment at 12 weeks
Echocardiographic findings - chamber size (mm)
Changes in chamber size (mm) at 12 weeks compared to baseline
Measured: From enrollment to the end of treatment at 12 weeks
Echocardiographic findings - ejection fraction (%)
Changes in ejection fraction (%) at 12 weeks compared to baseline
Measured: From enrollment to the end of treatment at 12 weeks
Echocardiographic findings - E/e'
Changes in E/e' at 12 weeks compared to baseline
Measured: From enrollment to the end of treatment at 12 weeks
Echocardiographic findings - global longitudinal strain (%)
Changes in global longitudinal strain (%) at 12 weeks compared to baseline
Measured: From enrollment to the end of treatment at 12 weeks
Epicardial Adipose tissue
% change of EAT from baseline to 12weeks
Measured: % change of EAT from baseline to 12weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start20 Jan 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Daewoong Pharmaceutical Co. LTD.
- Responsible party
- Principal investigator, Seong-Mi Park, M.D. Ph.D., Korea University Anam Hospital
- Investigators
- Seong-Mi Park, M.D., Ph.D., Principal investigator, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06782139
- Sponsor's protocol ID
- 2024AN0301
- Acronym
- ENVY
- Status last verified
- Aug 2025
- First submitted
- 9 Dec 2024
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of ENavogliflozin on Coronary microVascular and Cardiac Function in Patients With obesitY (ENVY)
- ClinicalTrials.gov ID
- NCT06782139
- Acronym / sponsor ID
- ENVY / 2024AN0301
- Conditions
- Obesity and Type 2 Diabetes
- Keywords
- Sodium-Glucose Cotransporter 2 inhibitors, Obesity, Diabetes, Coronary microvascular function, Epicardial adipose tissue
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Collaborators
- Daewoong Pharmaceutical Co. LTD.
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 17 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In recent years, the prevalence of obesity has increased, which acts as a significant risk factor for cardiovascular diseases. Obesity is closely related to reduced microvascular function, increased insulin resistance, and elevated blood pressure, and it is particularly known to be a major cause of heart failure with preserved ejection fraction (HFpEF) and diastolic dysfunction. Coronary microvascular dysfunction (CMD) leads to angina, myocardial infarction, and heart failure, which are associated with increased mortality. CMD has recently gained more importance as one of the key mechanisms of HFpEF. However, CMD often shows poor response to standard treatments, and when not recognized by healthcare providers, it can result in poor outcomes due to a lack of appropriate treatment.
Sodium-Glucose Cotransporter 2 (SGLT2) inhibitors are drugs that inhibit glucose reabsorption by blocking SGLT2 in the proximal tubules of the kidneys, thereby lowering blood sugar. Initially developed as oral hypoglycemic agents, previous randomized controlled studies have shown that they also have significant beneficial effects on heart failure and cardiovascular diseases not only in diabetic patients but also in non-diabetic patients. Recent studies have also demonstrated the effectiveness of SGLT2 inhibitors in patients with HFpEF. SGLT2 inhibitors reduce excessive sodium excretion through urine, which reduces fluid volume, lowers blood pressure, and decreases body weight, but the exact mechanism of their significant effects in cardiovascular diseases is still not fully understood. In particular, research on the effects of SGLT2 inhibitors on microvascular function is still limited. Recently, a randomized controlled study involving 16 diabetic patients reported an increase in myocardial flow reserve after 4 weeks of dapagliflozin administration, while another study involving 90 high-risk cardiovascular diabetic patients showed no significant change in myocardial flow reserve at 13 weeks with empagliflozin. Regarding enavogliflozin, a recent animal study in pigs suggested that it could improve vascular function by intervening in coronary endothelial cell function.
This study hypothesized that enavogliflozin would improve microvascular abnormalities and enhance heart function and cardiopulmonary exercise capacity in obesity-related cardiovascular diseases. Therefore, the objective of this study is to analyze the effects of enavogliflozin on heart function and microvascular function in obese patients compared to a placebo, and to evaluate the improvement in cardiopulmonary exercise capacity in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enavogliflozin | Experimental | Drug: EnavogliflozinThe 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. |
| Placebo | Placebo comparator | Drug: PlaceboThe 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. |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EnavogliflozinPatients 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 | Enavogliflozin |
| PlaceboPatients 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 |
Primary outcome
Coronary microvascular function
Time frame: From enrollment to the end of treatment at 12 weeks
The changes in coronary flow velocity reserve at 12 weeks compared to baseline in the active drug/placebo groups
16 secondary outcomes
Cardiopulmonary exercise capacity (VO2peak, mL/min/kg)
Time frame: From enrollment to the end of treatment at 12 weeks
Body weight (kg)
Time frame: From enrollment to the end of treatment at 12 weeks
Systolic and diastolic blood pressure (mmHg)
Time frame: From enrollment to the end of treatment at 12 weeks
Waist circumference (cm)
Time frame: From enrollment to the end of treatment at 12 weeks
Lipid profile
Time frame: From enrollment to the end of treatment at 12 weeks
Hemoglobin A1c (%)
Time frame: From enrollment to the end of treatment at 12 weeks
NT-proBNP (pg/mL)
Time frame: From enrollment to the end of treatment at 12 weeks
Self-assessment of sarcopenia (score)
Time frame: From enrollment to the end of treatment at 12 weeks
5-time chair rise test (sec)
Time frame: From enrollment to the end of treatment at 12 weeks
Body composition analysis - skeletal muscle mass index
Time frame: From enrollment to the end of treatment at 12 weeks
Body composition analysis - visceral fat area
Time frame: From enrollment to the end of treatment at 12 weeks
Echocardiographic findings - chamber size (mm)
Time frame: From enrollment to the end of treatment at 12 weeks
Echocardiographic findings - ejection fraction (%)
Time frame: From enrollment to the end of treatment at 12 weeks
Echocardiographic findings - E/e'
Time frame: From enrollment to the end of treatment at 12 weeks
Echocardiographic findings - global longitudinal strain (%)
Time frame: From enrollment to the end of treatment at 12 weeks
Epicardial Adipose tissue
Time frame: % change of EAT from baseline to 12weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Seong-Mi Park, M.D., Ph.D. principal investigator
Korea University Anam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Enavogliflozin in people with Obesity and Type 2 Diabetes, run by Korea University Anam Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact So Ree Kim, MD, PhD (82029205445, soree8826kim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronary microvascular function (time frame: From enrollment to the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.