Clinical Trials List
Protocol Number1378-0041
Active
2025-10-01 - 2030-06-30
Phase III
Recruiting11
A Phase III double-blind, randomised, parallel-group superiority trial to evaluate efficacy and safety of the combined use of oral vicadrostat (BI 690517) and empagliflozin compared with placebo and empagliflozin in participants with type 2 diabetes, hypertension and established cardiovascular disease
-
Trial Applicant
Boehringer Ingelheim
-
Sponsor
Boehringer Ingelheim Taiwan Ltd.。
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- JEN-KUANG LEE Division of General Internal Medicine
- YEN-HUNG LIN Division of General Internal Medicine
- 柯宗佑 Division of General Internal Medicine
- 陳盈憲 Division of General Internal Medicine
- 鄭人方 Division of General Internal Medicine
- 孟士瑋 Division of General Internal Medicine
- 林柏志 Division of General Internal Medicine
- 洪啟盛 Division of General Internal Medicine
- 賀立婷 Division of General Internal Medicine
- LIAN-YU LIN Division of General Internal Medicine
- HUNG-JU LIN Division of General Internal Medicine
- 陳俊凱 Division of General Internal Medicine
- Chih-Fan Yeh Division of General Internal Medicine
- Tzung-Dau Wang Division of General Internal Medicine
- 林廷澤 Division of General Internal Medicine
- MAO-HSIN LIN Division of General Internal Medicine
- Hsien Li Kao Division of General Internal Medicine
- 黃慶昌 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 黃文弘 Division of Cardiovascular Diseases
- 藍偉仁 Division of Cardiovascular Diseases
- 吳書豪 Division of Cardiovascular Diseases
- 蔡佳伶 Division of Cardiovascular Diseases
- 顏志軒 Division of General Internal Medicine
- 簡楨彥 Division of Cardiovascular Surgery
- 蔡憲岳 Division of Cardiovascular Diseases
- 宋國慈 Division of Cardiovascular Diseases
- 簡世杰 Division of General Internal Medicine
- 陳冠廷 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 劉文浩 Division of Cardiovascular Diseases
- 方燕楠 Division of Cardiovascular Diseases
- 鍾文榮 Division of Cardiovascular Diseases
- Huang-Chung Chen Division of Cardiovascular Diseases
- 柴漢東 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 吳承學 Division of Cardiovascular Diseases
- 張皓智 Division of Cardiovascular Diseases
- 蔡依霖 Division of Cardiovascular Diseases
- Wen-Chung Yu Division of Cardiovascular Diseases
- 張俊欽 Division of Cardiovascular Diseases
- Tse-Min Lu Division of Cardiovascular Diseases
- Chern-En Chiang Division of Cardiovascular Diseases
- 李慶威 Division of Cardiovascular Diseases
- 蔡泉財 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 陳科維 Division of General Internal Medicine
- 謝禮全 Division of General Internal Medicine
- Wei-Chung Wang Division of Neurology
- 陳琦棟 Division of General Internal Medicine
- 魏榮廷 Division of General Internal Medicine
- 鄭英男 Division of General Internal Medicine
- 呂尚謁 Division of General Internal Medicine
- 黃志勤 Division of General Internal Medicine
- Ping-Han Lo Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Tsung-Hsien Lin
Co-Principal Investigator
- 朱志生
- Chun-Yuan Chu
- 吳韋璁
- 黃天祈
- 林子傑 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 陳志維 Division of Cardiovascular Diseases
- Chien-Yi Hsu Division of Cardiovascular Diseases
- 鄭宇倫 Division of Cardiovascular Diseases
- Yung-Ta Kao Division of Cardiovascular Diseases
- 蕭卜源 Division of Cardiovascular Diseases
- 洪元 Division of Cardiovascular Diseases
- 陳彥舟 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
JUN-SING WANG
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Type 2 diabetes mellitus, hypertension, and established cardiovascular disease
Objectives
The objective of this study is to provide robust evidence demonstrating that, in addition to standard of care (SOC), vicadrostat 10 mg combined with empagliflozin 10 mg is superior to vicadrostat placebo combined with empagliflozin 10 mg in reducing cardiovascular (CV) risk and preventing heart failure (HF) in participants with type 2 diabetes mellitus (T2DM), hypertension (HTN), and established cardiovascular disease (CVD).
The primary objective is to demonstrate the superiority of vicadrostat 10 mg combined with empagliflozin 10 mg over vicadrostat placebo combined with empagliflozin 10 mg in participants with T2DM, HTN, and established CVD with respect to time to first occurrence of CV death, hospitalization for heart failure (HHF), or urgent heart failure (HF) visit.
The key secondary objectives are to demonstrate the superiority of vicadrostat 10 mg combined with empagliflozin 10 mg versus vicadrostat placebo combined with empagliflozin 10 mg in terms of:
Time to first occurrence of CV death or HHF event
Absolute change from baseline in mean systolic blood pressure (SBP) at Week 24
Relative change from baseline in urinary albumin-to-creatinine ratio (UACR) at Week 24
Time to first occurrence of the composite endpoint of renal disease progression, HHF, or CV death
Time to first occurrence of 4-point major adverse cardiovascular events (4P-MACE)
Rate of all-cause hospitalizations (first and recurrent)
Time to first occurrence of new-onset atrial fibrillation or atrial flutter (for participants without prior history of AF/AFL) or CV death
Time to all-cause mortality
The other secondary objectives are to evaluate vicadrostat 10 mg combined with empagliflozin 10 mg versus vicadrostat placebo combined with empagliflozin 10 mg in terms of:
Time to CV death
Time to first occurrence of HHF
Rate of HHF events (first and recurrent)
Time to first occurrence of new-onset HF or CV death
Additionally, the study will assess the absolute change from baseline in mean diastolic blood pressure (DBP) at Week 24.
Test Drug
Film-coated tablet
Film-coated tablet
Film-coated tablet
Active Ingredient
BI 690517 (Vicadrostat) or matching placebo
Empagliflozin
Empagliflozin
Dosage Form
116
116
116
Dosage
10 MG
Endpoints
• Time to first occurrence of CV death or HFE (defined as hospitalization for heart failure [HHF] or urgent heart failure [HF] visit). CV death includes death of undetermined cause.
Inclution Criteria
Aged ≥ 18 years at the time of consent.
Prior to any study-specific procedures, signed and dated written informed consent in accordance with the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and applicable local laws.
Male or female participants. Women of childbearing potential (WOCBP) must be willing and able to use a highly effective method of contraception as defined in ICH M3 (R2)—that is, a method with a failure rate of less than 1% per year when used consistently and correctly. The participant information sheet provides a list of acceptable methods and required durations of use.
Participants with a history of hypertension (HTN) who are receiving active pharmacologic treatment based on best achievable standard of care (SOC) in accordance with relevant local or international guidelines, as judged by the investigator.
Participants with a history of type 2 diabetes mellitus (T2DM) who are receiving active pharmacologic treatment based on best achievable SOC in accordance with relevant local or international guidelines, as judged by the investigator.
Participants with established cardiovascular (CV) disease who are receiving active pharmacologic treatment based on best achievable SOC in accordance with relevant local or international guidelines, as judged by the investigator. Established CV disease includes at least one of the following: coronary artery disease, peripheral artery disease, or cerebrovascular disease.
Coronary artery disease (CAD) is defined as:
▪ Previous myocardial infarction (MI) or prior coronary revascularization (e.g., coronary artery bypass grafting [CABG] or percutaneous coronary intervention [PCI]),
or
▪ ≥ 50% stenosis demonstrated by coronary angiography or other coronary imaging (e.g., coronary CT angiography), or presence of bypass grafts.
Peripheral artery disease (PAD) (symptomatic or asymptomatic) is defined as:
▪ Prior limb angioplasty, stenting, or bypass surgery,
or
▪ Prior amputation of a limb or foot due to circulatory insufficiency,
or
▪ Angiographic or non-invasive evidence of ≥ 50% stenosis in at least one limb or vascular territory,
or
▪ Ankle–brachial index < 0.9 in at least one limb with symptoms of intermittent claudication.
Cerebrovascular disease is defined as:
▪ History of ischemic stroke (transient ischemic attack, hemorrhagic stroke, primary intracerebral hemorrhage, or subarachnoid hemorrhage are not eligible),
or
▪ Prior cerebrovascular revascularization (e.g., carotid endarterectomy and/or stenting).
At screening (Visit 1), presence of at least one additional risk factor for heart failure (HF), such as:
o Type 2 diabetes mellitus requiring insulin therapy,
or
o Elevated natriuretic peptides, defined as NT-proBNP > 125 pg/mL or BNP > 35 pg/mL (documented within the past 6 months or at screening [Visit 1])**,
or
o Evidence of left ventricular hypertrophy (LVH):
▪ History of LVH diagnosed by echocardiography or cardiac magnetic resonance imaging (MRI),
or
▪ Evidence of LVH on 12-lead electrocardiogram (ECG) according to the Sokolow-Lyon index: RV5 + SV1 > 3.5 mV,
or
o History of atrial fibrillation or atrial flutter,
or
o Multivessel disease, defined as PAD plus at least one of the following: CAD or cerebrovascular disease,
or
o Prescription of a loop diuretic for at least 30 days within the 3 months preceding screening (Visit 1),
or
o Mean systolic blood pressure ≥ 140 mmHg at screening (Visit 1) despite treatment with at least two antihypertensive agents,
or
o Urinary albumin-to-creatinine ratio (UACR) ≥ 200 mg/g (documented within the past 6 months or at screening [Visit 1])*.
* BNP/NT-proBNP or UACR measurements performed by a local laboratory within 6 months prior to screening are acceptable. At screening (Visit 1), NT-proBNP and UACR will be analyzed by a central laboratory.
Prior to any study-specific procedures, signed and dated written informed consent in accordance with the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and applicable local laws.
Male or female participants. Women of childbearing potential (WOCBP) must be willing and able to use a highly effective method of contraception as defined in ICH M3 (R2)—that is, a method with a failure rate of less than 1% per year when used consistently and correctly. The participant information sheet provides a list of acceptable methods and required durations of use.
Participants with a history of hypertension (HTN) who are receiving active pharmacologic treatment based on best achievable standard of care (SOC) in accordance with relevant local or international guidelines, as judged by the investigator.
Participants with a history of type 2 diabetes mellitus (T2DM) who are receiving active pharmacologic treatment based on best achievable SOC in accordance with relevant local or international guidelines, as judged by the investigator.
Participants with established cardiovascular (CV) disease who are receiving active pharmacologic treatment based on best achievable SOC in accordance with relevant local or international guidelines, as judged by the investigator. Established CV disease includes at least one of the following: coronary artery disease, peripheral artery disease, or cerebrovascular disease.
Coronary artery disease (CAD) is defined as:
▪ Previous myocardial infarction (MI) or prior coronary revascularization (e.g., coronary artery bypass grafting [CABG] or percutaneous coronary intervention [PCI]),
or
▪ ≥ 50% stenosis demonstrated by coronary angiography or other coronary imaging (e.g., coronary CT angiography), or presence of bypass grafts.
Peripheral artery disease (PAD) (symptomatic or asymptomatic) is defined as:
▪ Prior limb angioplasty, stenting, or bypass surgery,
or
▪ Prior amputation of a limb or foot due to circulatory insufficiency,
or
▪ Angiographic or non-invasive evidence of ≥ 50% stenosis in at least one limb or vascular territory,
or
▪ Ankle–brachial index < 0.9 in at least one limb with symptoms of intermittent claudication.
Cerebrovascular disease is defined as:
▪ History of ischemic stroke (transient ischemic attack, hemorrhagic stroke, primary intracerebral hemorrhage, or subarachnoid hemorrhage are not eligible),
or
▪ Prior cerebrovascular revascularization (e.g., carotid endarterectomy and/or stenting).
At screening (Visit 1), presence of at least one additional risk factor for heart failure (HF), such as:
o Type 2 diabetes mellitus requiring insulin therapy,
or
o Elevated natriuretic peptides, defined as NT-proBNP > 125 pg/mL or BNP > 35 pg/mL (documented within the past 6 months or at screening [Visit 1])**,
or
o Evidence of left ventricular hypertrophy (LVH):
▪ History of LVH diagnosed by echocardiography or cardiac magnetic resonance imaging (MRI),
or
▪ Evidence of LVH on 12-lead electrocardiogram (ECG) according to the Sokolow-Lyon index: RV5 + SV1 > 3.5 mV,
or
o History of atrial fibrillation or atrial flutter,
or
o Multivessel disease, defined as PAD plus at least one of the following: CAD or cerebrovascular disease,
or
o Prescription of a loop diuretic for at least 30 days within the 3 months preceding screening (Visit 1),
or
o Mean systolic blood pressure ≥ 140 mmHg at screening (Visit 1) despite treatment with at least two antihypertensive agents,
or
o Urinary albumin-to-creatinine ratio (UACR) ≥ 200 mg/g (documented within the past 6 months or at screening [Visit 1])*.
* BNP/NT-proBNP or UACR measurements performed by a local laboratory within 6 months prior to screening are acceptable. At screening (Visit 1), NT-proBNP and UACR will be analyzed by a central laboratory.
Exclusion Criteria
History of heart failure (HF) or hospitalization for HF, or receiving HF treatment at Screening (Visit 1) or Randomization (Visit 2).
At Screening (Visit 1), NT-proBNP > 600 pg/mL in participants with sinus rhythm, or NT-proBNP > 1200 pg/mL in participants with atrial fibrillation or atrial flutter (analyzed by the central laboratory).
At Screening (Visit 1), atrial fibrillation or atrial flutter with a resting heart rate > 110 bpm on ECG.
At Screening (Visit 1), untreated advanced conduction disorders (e.g., symptomatic bradycardia, sick sinus syndrome, Mobitz type II second-degree atrioventricular block, or third-degree heart block), or untreated clinically significant ventricular arrhythmias.
Treatment with mineralocorticoid receptor antagonists (MRAs; e.g., spironolactone, eplerenone, finerenone) within 2 weeks before Screening (Visit 1), or, in the investigator’s judgment, anticipated need for such treatment before Randomization (Visit 2) or during the study. MRA therapy should not be interrupted solely for study eligibility.
Treatment with amiloride or other potassium-sparing diuretics within 2 weeks before Screening (Visit 1), or, in the investigator’s judgment, anticipated need for such treatment before Randomization (Visit 2) or during the study.
At Screening (Visit 1), current treatment with, or anticipated need for before Randomization (Visit 2) or during the study, any of the following:
• Direct renin inhibitors (e.g., aliskiren)
• Concomitant use of more than one angiotensin-converting enzyme inhibitor (ACEi) and/or angiotensin receptor blocker (ARB) (including angiotensin receptor–neprilysin inhibitors [ARNi])
• Other aldosterone synthase inhibitors (e.g., baxdrostat)
• Systemic mineralocorticoid replacement therapy (e.g., fludrocortisone)
Use of potassium binders (e.g., sodium zirconium cyclosilicate, patiromer, or sodium polystyrene sulfonate) within 4 weeks before Screening (Visit 1).
History of hyperkalemia requiring hospitalization within 12 weeks before Screening (Visit 1).
Serum potassium > 5.2 mmol/L measured by the central laboratory at Screening (Visit 1). Note: one retest of serum potassium is allowed during screening.
Impaired renal function, defined as eGFR < 20 mL/min/1.73 m² (calculated by CKD-EPI formula) at Screening (Visit 1) by the central laboratory, or currently receiving renal replacement therapy. Note: one retest of eGFR is allowed during screening.
Known adrenal insufficiency (e.g., Addison’s disease) or Cushing’s syndrome.
Symptomatic hypotension and/or mean systolic blood pressure (SBP) < 100 mmHg at Screening (Visit 1) or up to and including Randomization (Visit 2).
Mean SBP ≥ 180 mmHg or mean diastolic blood pressure (DBP) ≥ 120 mmHg at Screening (Visit 1) or Randomization (Visit 2).
Myocardial infarction, stroke, transient ischemic attack, acute inflammatory heart disease (e.g., acute myocarditis), or major surgery (as judged by the investigator) within 12 weeks before Screening (Visit 1) or up to Randomization (Visit 2), or planned major non-urgent surgery (e.g., hip replacement, coronary artery bypass grafting [CABG]).
Percutaneous vascular intervention or any angiography using iodine-based contrast agents within 1 week before Randomization (Visit 2).
Known severe valvular heart disease (stenotic or regurgitant) as judged by the investigator; excluding secondary mitral regurgitation due to left ventricular dilatation, or participants scheduled for surgical or invasive intervention for valvular disease at Screening (Visit 1) or anticipated during the study.
ALT or AST > 3 × upper limit of normal (ULN) at Screening (Visit 1) per central laboratory.
Known severe hepatic impairment (Child-Pugh class C cirrhosis).
History of gastrointestinal surgery or disease that, in the investigator’s judgment, may interfere with absorption of the study drug (e.g., intestinal resection, inflammatory bowel disease, active gastritis, pancreatitis).
Type 1 diabetes mellitus, history of diabetes due to other autoimmune causes (e.g., latent autoimmune diabetes in adults [LADA]), or uncontrolled type 2 diabetes (HbA1c > 10% per central laboratory) at Screening (Visit 1).
History of ketoacidosis within 5 years before Screening (Visit 1) or up to Randomization (Visit 2).
Any documented active or suspected malignancy within 5 years before Screening (Visit 1) or up to Randomization (Visit 2), except adequately treated basal cell carcinoma of the skin, cervical carcinoma in situ, or low-risk prostate cancer (pretreatment PSA < 10 ng/mL, Gleason score ≤ 6, and clinical stage T1c or T2a).
Any condition expected to limit life expectancy to < 1 year, as determined by the investigator.
Current or planned use of prohibited medications or any drugs considered likely to interfere with study conduct or safety.
Anticipated non-compliance with the study protocol or inability to complete study procedures (e.g., chronic alcohol or drug abuse, or any condition rendering the participant unreliable in the investigator’s opinion).
Previous randomization in this study.
Current participation in another investigational drug or device study, or completion of such a study or investigational treatment less than 30 days before Screening (Visit 1). Participation in purely observational studies is permitted.
Pregnant or breastfeeding women, or women planning to become pregnant during the study.
Any other condition not covered by the exclusion criteria that, in the investigator’s judgment, could compromise participant safety or protocol adherence.
Individuals considered vulnerable according to local regulations (e.g., pregnant or breastfeeding women; persons deprived of liberty; minors; individuals lacking sufficient power, intelligence, education, resources, or physical strength to protect their own interests; or those unable to provide informed consent).
Known intolerance, hypersensitivity, or allergy to vicadrostat, empagliflozin, other sodium-glucose cotransporter-2 (SGLT2) inhibitors, and/or any excipients (including lactose).
At Screening (Visit 1), NT-proBNP > 600 pg/mL in participants with sinus rhythm, or NT-proBNP > 1200 pg/mL in participants with atrial fibrillation or atrial flutter (analyzed by the central laboratory).
At Screening (Visit 1), atrial fibrillation or atrial flutter with a resting heart rate > 110 bpm on ECG.
At Screening (Visit 1), untreated advanced conduction disorders (e.g., symptomatic bradycardia, sick sinus syndrome, Mobitz type II second-degree atrioventricular block, or third-degree heart block), or untreated clinically significant ventricular arrhythmias.
Treatment with mineralocorticoid receptor antagonists (MRAs; e.g., spironolactone, eplerenone, finerenone) within 2 weeks before Screening (Visit 1), or, in the investigator’s judgment, anticipated need for such treatment before Randomization (Visit 2) or during the study. MRA therapy should not be interrupted solely for study eligibility.
Treatment with amiloride or other potassium-sparing diuretics within 2 weeks before Screening (Visit 1), or, in the investigator’s judgment, anticipated need for such treatment before Randomization (Visit 2) or during the study.
At Screening (Visit 1), current treatment with, or anticipated need for before Randomization (Visit 2) or during the study, any of the following:
• Direct renin inhibitors (e.g., aliskiren)
• Concomitant use of more than one angiotensin-converting enzyme inhibitor (ACEi) and/or angiotensin receptor blocker (ARB) (including angiotensin receptor–neprilysin inhibitors [ARNi])
• Other aldosterone synthase inhibitors (e.g., baxdrostat)
• Systemic mineralocorticoid replacement therapy (e.g., fludrocortisone)
Use of potassium binders (e.g., sodium zirconium cyclosilicate, patiromer, or sodium polystyrene sulfonate) within 4 weeks before Screening (Visit 1).
History of hyperkalemia requiring hospitalization within 12 weeks before Screening (Visit 1).
Serum potassium > 5.2 mmol/L measured by the central laboratory at Screening (Visit 1). Note: one retest of serum potassium is allowed during screening.
Impaired renal function, defined as eGFR < 20 mL/min/1.73 m² (calculated by CKD-EPI formula) at Screening (Visit 1) by the central laboratory, or currently receiving renal replacement therapy. Note: one retest of eGFR is allowed during screening.
Known adrenal insufficiency (e.g., Addison’s disease) or Cushing’s syndrome.
Symptomatic hypotension and/or mean systolic blood pressure (SBP) < 100 mmHg at Screening (Visit 1) or up to and including Randomization (Visit 2).
Mean SBP ≥ 180 mmHg or mean diastolic blood pressure (DBP) ≥ 120 mmHg at Screening (Visit 1) or Randomization (Visit 2).
Myocardial infarction, stroke, transient ischemic attack, acute inflammatory heart disease (e.g., acute myocarditis), or major surgery (as judged by the investigator) within 12 weeks before Screening (Visit 1) or up to Randomization (Visit 2), or planned major non-urgent surgery (e.g., hip replacement, coronary artery bypass grafting [CABG]).
Percutaneous vascular intervention or any angiography using iodine-based contrast agents within 1 week before Randomization (Visit 2).
Known severe valvular heart disease (stenotic or regurgitant) as judged by the investigator; excluding secondary mitral regurgitation due to left ventricular dilatation, or participants scheduled for surgical or invasive intervention for valvular disease at Screening (Visit 1) or anticipated during the study.
ALT or AST > 3 × upper limit of normal (ULN) at Screening (Visit 1) per central laboratory.
Known severe hepatic impairment (Child-Pugh class C cirrhosis).
History of gastrointestinal surgery or disease that, in the investigator’s judgment, may interfere with absorption of the study drug (e.g., intestinal resection, inflammatory bowel disease, active gastritis, pancreatitis).
Type 1 diabetes mellitus, history of diabetes due to other autoimmune causes (e.g., latent autoimmune diabetes in adults [LADA]), or uncontrolled type 2 diabetes (HbA1c > 10% per central laboratory) at Screening (Visit 1).
History of ketoacidosis within 5 years before Screening (Visit 1) or up to Randomization (Visit 2).
Any documented active or suspected malignancy within 5 years before Screening (Visit 1) or up to Randomization (Visit 2), except adequately treated basal cell carcinoma of the skin, cervical carcinoma in situ, or low-risk prostate cancer (pretreatment PSA < 10 ng/mL, Gleason score ≤ 6, and clinical stage T1c or T2a).
Any condition expected to limit life expectancy to < 1 year, as determined by the investigator.
Current or planned use of prohibited medications or any drugs considered likely to interfere with study conduct or safety.
Anticipated non-compliance with the study protocol or inability to complete study procedures (e.g., chronic alcohol or drug abuse, or any condition rendering the participant unreliable in the investigator’s opinion).
Previous randomization in this study.
Current participation in another investigational drug or device study, or completion of such a study or investigational treatment less than 30 days before Screening (Visit 1). Participation in purely observational studies is permitted.
Pregnant or breastfeeding women, or women planning to become pregnant during the study.
Any other condition not covered by the exclusion criteria that, in the investigator’s judgment, could compromise participant safety or protocol adherence.
Individuals considered vulnerable according to local regulations (e.g., pregnant or breastfeeding women; persons deprived of liberty; minors; individuals lacking sufficient power, intelligence, education, resources, or physical strength to protect their own interests; or those unable to provide informed consent).
Known intolerance, hypersensitivity, or allergy to vicadrostat, empagliflozin, other sodium-glucose cotransporter-2 (SGLT2) inhibitors, and/or any excipients (including lactose).
The Estimated Number of Participants
-
Taiwan
95 participants
-
Global
11800 participants
