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Clinical Trial Details

Trial ID: L3269
Source ID: NCT06782139
Associated Drug: Enavogliflozin
Title: Effects of Enavogliflozin on Coronary Microvascular and Cardiac Function in Obesity
Acronym: ENVY
Status: RECRUITING
Study Results: NO
Results:
Conditions: Obesity and Type 2 Diabetes
Interventions: DRUG: Enavogliflozin|DRUG: Placebo
Outcome Measures: Primary: 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: 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, From enrollment to the end of treatment at 12 weeks|Body weight (kg), Changes in body weight (kg) at 12 weeks compared to baseline, 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, From enrollment to the end of treatment at 12 weeks|Waist circumference (cm), Changes in waist circumference (cm) at 12 weeks compared to baseline, 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, From enrollment to the end of treatment at 12 weeks|Hemoglobin A1c (%), Changes in hemoglobin A1c (%) at 12 weeks compared to baseline, 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, 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, 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, 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, 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, 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, From enrollment to the end of treatment at 12 weeks|Echocardiographic findings - ejection fraction (%), Changes in ejection fraction (%) at 12 weeks compared to baseline, From enrollment to the end of treatment at 12 weeks|Echocardiographic findings - E/e', Changes in E/e' at 12 weeks compared to baseline, 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, From enrollment to the end of treatment at 12 weeks
Sponsor/Collaborators: Sponsor: Korea University Anam Hospital | Collaborators: Daewoong Pharmaceutical Co. LTD.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 30
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2025-01-20
Completion Date: 2025-12-31
Results First Posted:
Last Update Posted: 2025-03-26
Locations: Korea University Anam Hospital, Seoul, 02841, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT06782139