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Taking people in ChinaPhase 3

Tests vicadrostat with empagliflozin in adults with type 2 diabetes and heart disease

Tests vicadrostat taken with empagliflozin in adults with diabetes, high blood pressure and heart disease.

Plain-language title generated from the registry record
Registry title: EASi-PROTKT™ - A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease

Key facts

Where
Baotou, Beijing, Changchun, Changsha, Changzhou, Chengdu, Chongqing, Dalian, Fuzhou, Guangzhou, Guiyang, Haikou, Hangzhou, Harbin, Hefei, Huizhou, Jiangmen, Jinan, Jining, Jinzhou, Lanzhou, Lishui, Luoyang, Macau, Nanchang, Nanjing, Nanning, Nantong, Nanyang, Ningbo, Pingxiang, Qinhuangdao, Shanghai, Shenyang, Siping, Suzhou, Tianjin, Wenzhou, Wuhan, Xi'an, Xiamen, Xiangyang, Xianyang, Xuancheng, Xuzhou, Yinchuan, Zhenjiang, and Zibo, ChinaSee the 65 sites
Phase
Phase 3

Where in China

  • Baotou Central HospitalBaotou, ChinaTaking people
  • Peking University Third HospitalBeijing, ChinaTaking people
  • Xuanwu Hospital, Capital Medical UniversityBeijing, ChinaTaking people
  • China-Japan Friendship HospitalBeijing, ChinaNo longer taking part
  • China-Japan Union Hospital of JiLin UniversityChangchun, ChinaTaking people
  • Jilin Province People's HospitalChangchun, ChinaTaking people
  • Changsha Central HospitalChangsha, ChinaTaking people
  • The Second Xiangya Hospital of Central South UniversityChangsha, ChinaTaking people
  • The Third Hospital of ChangshaChangsha, ChinaTaking people
  • The Third Xiangya Hospital of Central South UniversityChangsha, ChinaTaking people
  • Changzhou Second People's HospitalChangzhou, ChinaTaking people
  • Sichuan Provincial People's HospitalChengdu, ChinaTaking people
  • West China Hospital，Sichuan UniversityChengdu, ChinaTaking people
  • Second Affiliated Hospital Chongqing Medical UniversityChongqing, ChinaTaking people
  • Center Hospital of DalianDalian, ChinaTaking people
  • The First Affiliated Hospital of Fujian Medical UniversityFuzhou, ChinaTaking people
  • Nanfang HosptialGuangzhou, ChinaTaking people
  • The Affiliated Panyu Central Hospital of Guangzhou Medical UniversityGuangzhou, ChinaTaking people
  • The Affiliated Hospital of Guizhou Medical UniversityGuiyang, ChinaTaking people
  • Hainan General HospitalHaikou, ChinaTaking people
  • Zhejiang Province People's HospitalHangzhou, ChinaTaking people
  • The First Affiliated Hospital of Harbin Medical UniversityHarbin, ChinaTaking people
  • Anhui Provincial HospitalHefei, ChinaTaking people
  • Huizhou Central People's HospitalHuizhou, ChinaTaking people
  • Jiangmen Central HospitalJiangmen, ChinaTaking people
  • Center Hospital of JinanJinan, ChinaTaking people
  • Affiliated Hospital of Jining Medical UniversityJining, ChinaTaking people
  • Jining No. 1 People's Hospital.Jining, ChinaTaking people
  • The First Affiliated Hospital of Jinzhou Medical UniversityJinzhou, ChinaTaking people
  • Lanzhou University Second HospitalLanzhou, ChinaTaking people
  • Lishui Municipal Central HospitalLishui, ChinaTaking people
  • Luoyang Third People's HospitalLuoyang, ChinaTaking people
  • The First Affiliated Hospital of Henan University of Science and TechnologyLuoyang, ChinaTaking people
  • University Hospital_Macau University of Science and TechnologyMacau, ChinaTaking people
  • Nanchang People's HospitalNanchang, ChinaTaking people
  • The Second Affiliated Hospital to Nanchang UniversityNanchang, ChinaTaking people
  • Nanjing Drum Tower hospitalNanjing, ChinaTaking people
  • The Second Affiliated Hospital of Nanjing Medical UniversityNanjing, ChinaTaking people
  • Zhongda Hospital Southeast UniversityNanjing, ChinaTaking people
  • The People's Hospital of Guangxi Zhuang Autonomous RegionNanning, ChinaTaking people
  • Affiliated Hospital of Nantong UniversityNantong, ChinaTaking people
  • Nanyang Second General HospitalNanyang, ChinaTaking people
  • The First Affiliated Hospital of Ningbo UniversityNingbo, ChinaTaking people
  • Pingxiang People's HospitalPingxiang, ChinaTaking people
  • First Hospital of QinhuangdaoQinhuangdao, ChinaTaking people
  • Centre Hospital of Putuo District, ShanghaiShanghai, ChinaTaking people
  • Shanghai East HospitalShanghai, ChinaTaking people
  • Shanghai General HospitalShanghai, ChinaTaking people
  • People's Hospital of Liaoning ProvinceShenyang, ChinaTaking people
  • Siping Central People's HospitalSiping, ChinaTaking people
  • The First Affiliated Hospital of Soochow UniversitySuzhou, ChinaTaking people
  • The Fourth Central Hospital of TianjinTianjin, ChinaTaking people
  • Tianjin Union Medical Center (Nankai University Affiliated Hospital)Tianjin, ChinaTaking people
  • The First Affiliated Hospital of Wenzhou Medical UniversityWenzhou, ChinaTaking people
  • Hubei Province Zhongshan HospitalWuhan, ChinaTaking people
  • Renmin Hospital of Wuhan UniversityWuhan, ChinaTaking people
  • Shaanxi provincial people's hospitalXi'an, ChinaTaking people
  • Xiamen Cardiovascular Hospital Xiamen UniversityXiamen, ChinaTaking people
  • Xiangyang Central HospitalXiangyang, ChinaTaking people
  • Xianyang Hospital of Yan'an UniversityXianyang, ChinaTaking people
  • The People's Hospital Of Xuancheng CityXuancheng, ChinaTaking people
  • The Affiliated Hospital of Xuzhou Medical CollegeXuzhou, ChinaTaking people
  • General Hospital of Ningxia Medical UniversityYinchuan, ChinaTaking people
  • Affiliated Hospital of Jiangsu UniversityZhenjiang, ChinaTaking people
  • Zibo Municipal HospitalZibo, ChinaTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Boehringer Ingelheim
Trial code
NCT07064473EU 2025-521188-11-00
Record updated
28 October 2026
Original description
This study is open to adults with type 2 diabetes, high blood pressure, and cardiovascular disease. People can join the study if they have these conditions and do not have a history of heart failure. The purpose of this study is to find out if a medicine called vicadrostat, when taken with empagliflozin, helps reduce cardiovascular risk in people with these conditions. The study will compare this combination to a placebo version of vicadrostat with empagliflozin.Read full original descriptionShow less

EASi-PROTKT™ - 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

This study is open to adults with type 2 diabetes, high blood pressure, and cardiovascular disease. People can join the study if they have these conditions and do not have a history of heart failure. The purpose of this study is to find out if a medicine called vicadrostat, when taken with empagliflozin, helps reduce cardiovascular risk in people with these conditions. The study will compare this combination to a placebo version of vicadrostat with empagliflozin.

Participants are put into 2 groups randomly, which means by chance. One group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets with empagliflozin. Placebo tablets look like vicadrostat tablets but do not contain any medicine.

Participants take a tablet once per day for 2 and a half years and up to 4 years and 3 months. All participants also continue their medication for type 2 diabetes, high blood pressure, and cardiovascular disease. Participants have an equal chance of receiving the study medicine or placebo.

Participants are in the study for up to 4 years and 3 months. During this time, they visit the study site regularly. During these visits, doctors collect information about participants' health and take blood samples. The doctors document when participants experience cardiovascular events. The doctors also regularly check participants' health and take note of any unwanted effects.

Inclusion: At least 18 years old at time of consent; Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial; Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2); Participants with medical history of hypertension and on active pharmacological treatment; Participants with medical history of type 2 diabetes mellitus (T2DM) and on active pharmacological treatment; Established cardiovascular (CV) disease and on active pharmacological treatment; At least one additional risk factor for developing heart failure (HF).

Exclusion: Treatment with an Mineralocorticoid receptor antagonist (MRA); Receiving the following treatments at Visit 1 (screening) or requiring such treatment before Visit 2 (randomisation), or planned during the trial:; A direct renin inhibitor (e.g. aliskiren); More than one Angiotensin-converting enzyme inhibitor (ACEi) and/or Angiotensin receptor blocker (ARB) (including Angiotensin receptor-neprilysin inhibitor (ARNi)) used simultaneously; Other aldosterone synthase inhibitors (e.g. baxdrostat); Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) Further exclusion criteria apply; History of HF or hospitalization for HF or treatment of HF; Atrial fibrillation or Atrial flutter with a resting heart rate >110 beats per minute (bpm) documented by echocardiogram (ECG) at Visit 1 (screening); Advanced untreated conduction disease or untreated clinically relevant ventricular arrhythmia at Visit 1 (screening); Treatment with amiloride or other potassium-sparing diuretic.

ClinicalTrials.gov NCT07064473 · EU CTIS 2025-521188-11-00