CTRI

FULL DETAILS (Read-only) -> Click Here to Create PDF for Current Dataset of Trial

CTRI Number

CTRI/2025/11/097088 [Registered on: 07/11/2025] Trial Registered Prospectively

Last Modified On:

30/10/2025

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Drug

Study Design

Other

Public Title of Study

A study to test vicadrostat (BI 690517) taken together with empagliflozin in people with type 2 diabetes, high blood pressure, and cardiovascular disease

Scientific Title of Study

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 Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
1378-0041 Version 1.0 dated 02 May 2025	Protocol Number
2025-521188-11-00	EudraCT
U1111-1319-9064	UTN

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name
Designation
Affiliation
Address
Phone
Fax
Email

Details of Contact Person
Scientific Query

Name	Shweta Pradhan
Designation	Head Clinical Operations
Affiliation	IQVIA RDS (India) Private Limited
Address	IQVIA RDS (India) Private Limited Omega Embassy Tech Square, Marathahalli - Sarjapura, Outer Ring Road, Kadubeesanahalli Bangalore KARNATAKA 560103 India
Phone	9513774664
Fax
Email	shweta.pradhan@iqvia.com

Details of Contact Person
Public Query

Name	Shweta Pradhan
Designation	Head Clinical Operations
Affiliation	IQVIA RDS (India) Private Limited
Address	Omega Embassy Tech Square, Marathahalli - Sarjapura, Outer Ring Road, Kadubeesanahalli KARNATAKA 560103 India
Phone	9513774664
Fax
Email	shweta.pradhan@iqvia.com

Source of Monetary or Material Support

Boehringer Ingelheim International GmbH Binger Strasse 173 55216 Ingelheim am Rhein, Germany

Primary Sponsor

Name	Boehringer Ingelheim International GmbH
Address	Binger Str. 173, 55218 Ingelheim am Rhein,Germany
Type of Sponsor	Pharmaceutical industry-Global

Details of Secondary Sponsor

Name	Address
IQVIA RDS India Private Limited	Omega Embassy TechSquare Marathahalli-Sarjapur Outer Ring Road, Kadubeesanahalli, Bangalore – 560103, Karnataka, India

Countries of Recruitment

Argentina
Australia
Austria
Belgium
Brazil
Bulgaria
Canada
Chile
China
Colombia
Croatia
Czech Republic
Denmark
Egypt
Finland
France
Germany
Greece
Hong Kong
Hungary
India
Ireland
Israel
Italy
Japan
Latvia
Lithuania
Malaysia
Mexico
Netherlands
New Zealand
Norway
Philippines
Poland
Portugal
Republic of Korea
Romania
Saudi Arabia
Serbia
Singapore
Slovakia
South Africa
Spain
Sweden
Switzerland
Taiwan
Thailand
Turkey
United Kingdom
United States of America
Viet Nam

Sites of Study

No of Sites = 18
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Tirthankar Chaudhury	Apollo Multispeciality Hospitals limited	58, Canal Circular Road - 700054 Kolkata WEST BENGAL	9831322394 tchaudhuryc05@gmail.com
Dr Divyaprakash Mada	Bangalore Medical College and Research Institute	Department of Cardiology, KR road, Fort - 560002 Bangalore KARNATAKA	8026706264 drdivyaprakashbmc@gmail.com
Dr Upendra Kaul	Batra hospital and Medical Research Centre	1, Tughlakabad Institutional Area, Mehrauli Badarpur Road 110062 New Delhi DELHI	9811150518 upendra.kaul@batrahospitaldelhi.org
Dr Manojkumar Bhavarilal Chopada	Chopda Medicare & Research Centre Pvt. Ltd	Magnum Heart Institute, 3/5, Patil Lane No. 1, Laxmi Nagar, Near K.B.H. Vidyalaya, Canada Corner - 422005 Nashik MAHARASHTRA	0253-2316200 drchopdamanoj@gmail.com
Dr Vaishali Chetan Deshmukh	Deenanath Mangeshkar Hospital and Research Center	Super speciality Building, Ground floor, Endocrinology Department, Deenanath Mangeshkar Hospital and Research Center, Erandwane, 411004 Pune MAHARASHTRA	9850811450 drvaishaliresearch@gmail.com
Dr Vishal Rastogi	Fortis Escorts Heart Institute	Okhla Road -110025 New Delhi DELHI	011-26825002 vishal.rastogi@fortishealthcare.com
Dr Vimal Mehta	G.B. Pant Institute of Postgraduate Medical Education & Research	Jawahar Lal Nehru Marg 110002 New Delhi DELHI	9718599105 drvimalmehta@yahoo.co.in
Dr Parag Shah	Gujarat Endocrine Centre- a unit of Gujarat Endocrine Pvt Ltd	AWS-3 BLOCK B 518-526, Opp Manav Mandir, Nr Helmet Cross Road - 380052 Ahmadabad GUJARAT	9824042688 paragendo@gmail.com
Dr Jothydev Kesavadev	Jothydev’s Diabetes Research Centre	JDC Juction Konkalam Road Mudavanmugal Poojappura 695032 Thiruvananthapuram KERALA	9895040055 jothydev@gmail.com
Dr Ajit Raghunath Bhagwat	Kamalnayan Bajaj Hospital	Gut no 43, Satara Pariser, Beed bypass road Aurangabad MAHARASHTRA	9822050817 drbhagwat.knb@gamil.com
Dr Jenny Madhuri Gudivada	King George Hospital	Department of Cardiology, King George Hospital, Maharanipeta, -530002 Visakhapatnam ANDHRA PRADESH	9573472413 drjennymadhuriresearch@gmail.com
Dr Awadhesh Kumar Sharma	LPS Institute of Cardiology	GSVM Medical College, Kanpur Kanpur Nagar UTTAR PRADESH	9501958808 awakush@gmail.com
Dr Vijay Kumar Chopra	Max Super Speciality Hospital	(East Block) - A unite of Devki Devi Foundation 2, Press Enclave road, Saket, 110017 New Delhi DELHI	9650896800 Vijay.chopra@maxhealthcare.com
Dr Atul Damodar Abhyankar	Nirmal Hospital Pvt Ltd	Ring Road 395002 Surat GUJARAT	9824145738 heartfirst.surat@gmail.com
Dr Debmalya Sanyal	Rabindranath Tagore International Institute of Cardiac Sciences	Premises No 1489, (124) Mukundapur, E. M. Bypass - 700099 Kolkata WEST BENGAL	6289855117 debmalya.sanyal.dr@narayanahealth.org
Dr Pintu Nahata	S. P. Medical College & AG Hospitals	A-Block, Department of Cardiology Bikaner RAJASTHAN	9829060411 nahatapintu15@gmail.com
Dr Ashwani Mehta	Sir Ganga Ram Hospital	Sir Ganga Ram Hospital Marg, rajinder nagar 110060 New Delhi DELHI	9811057384 drashwanimehta@gmail.com
Dr Sunil Gupta	Sunil’s Diabetes Care and Research Centre Pvt. Ltd	42 Kendra Park, Ramdaspeth – 440010 Nagpur MAHARASHTRA	9823152111 drsunilgupta@gmail.com

Details of Ethics Committee

No of Ethics Committees= 18
Name of Committee	Approval Status
Ethics Committee Kamalnayan Bajaj Hospital_ Dr. Ajit Raghunath Bhagwat	Submittted/Under Review
Ethics Committee of BMCRI_ Dr. Divyaprakash Mada	Submittted/Under Review
Ethics Committee of Sunil’s Diabetes Care n Research Centre_ Dr. Sunil Gupta	Approved
Ethics committee, GSVM Medical College, Kanpur_ Dr. Awadhesh Kumar Sharma	Approved
Ethics Committee, S.P. Medical college_ Dr. Pintu Nahata	Approved
Institutional Ethic Committee_ Dr. Vaishali Chetan Deshmukh	Submittted/Under Review
Institutional Ethics Committee, Devki Devi Foundation_ Dr. Vijay Kumar Chopra	Submittted/Under Review
Institutional Ethics Committee, MAMC_ Prof. Dr. Vimal Mehta	Submittted/Under Review
Institutional Ethics Committee_ Dr. Jothydev Kesavadev	Submittted/Under Review
Institutional Ethics Committee_ Dr. Tirthankar Chaudhury	Submittted/Under Review
Institutional Ethics Committee_ Dr. Vishal Rastogi	Submittted/Under Review
King George Hospital, Institutional Ethics committee _Dr Jenny Madhuri Gudivada	Submittted/Under Review
Magna-Care Ethics Committee_ Dr. Manojkumar Bhavarilal Chopada	Submittted/Under Review
NHRTIICS Ethics Committee_ Dr. Debmalya Sanyal	Approved
Nirmal Hospital Pvt Ltd Ethics Committee_ Dr Atul Damodar Abhyankar	Approved
Sangini Hospital Ethics Committee_ Dr Parag Shah	Approved
Scientific Research and Ethical Review Committee_ Dr. Upendra Kaul	Submittted/Under Review
Sir Ganga Ram Hospital Ethics Committee_ Dr Ashwani Mehta	Submittted/Under Review

Regulatory Clearance Status from DCGI

Status

Approved/Obtained

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: I10\|\|Essential (primary) hypertension,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Empagliflozin	Dose: 1 tablet once daily Route: Oral Duration: Treatment duration for an individual participant may range between approximately 30 to 51 months (event-driven trial)
Intervention	Vicadrostat	Dose: 1 tablet once daily Route: oral Duration: Treatment duration for an individual participant may range between approximately 30 to 51 months (event-driven trial)

Inclusion Criteria

Age From	18.00 Year(s)
Age To	99.00 Year(s)
Gender	Both
Details	1. At least 18 years old at time of consent 2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial. 3. Male or female participants. WOCBP (see Section 4.2.2.3) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1 percent per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of use is provided in the participant information. 4. Participants with medical history of HTN and on active pharmacological treatment according to best possible SOC in accordance with applicable local per international guidelines (according to the judgment of the investigator) 5. Participants with medical history of T2DM and on active pharmacological treatment according to best possible SOC in accordance with applicable local international guidelines (according to the judgment of the investigator). 6. Established CV disease and on active pharmacological treatment according to best possible SOC in accordance with applicable local international guidelines (according to the judgment of the investigator). Established CV disease includes at least one of the following: coronary artery disease, or peripheral artery disease, or cerebrovascular disease.

ExclusionCriteria

Details

1. History of HF or hospitalization for HF or treatment of HF at Visit 1 (screening) and
Visit 2 (randomization)
2. NT-proBNP more than 600 pg per ml in participants with sinus rhythm or more than 1200 pg per ml in participants with atrial fibrillation or atrial flutter at Visit 1 (analysed at the central laboratory at screening)
3. Atrial fibrillation or Atrial flutter with a resting heart rate more than 110 bpm documented by ECG at Visit 1 (screening)
4. Treatment with an MRA (example. spironolactone, eplerenone, finerenone) within 2 weeks prior to Visit 1 (screening) or requiring such treatment before Visit 2 (randomisation) or planned during the trial based on the judgment of the investigator. Treatment with MRA
should not be interrupted with the intention of enrolment into the study
5. Treatment with amiloride or other potassium-sparing diuretic within 2 weeks prior to
Visit 1 (screening) or requiring such treatment before Visit 2 (randomisation) or planned
during the trial based on the judgment of the investigator
6. Receiving the following treatments at Visit 1 (screening) or requiring such treatment
before Visit 2 (randomisation), or planned during the trial:
o A direct renin inhibitor (e.g. aliskiren)
o More than one ACEi and or ARB (including ARNi) used simultaneously
o Other aldosterone synthase inhibitors (example baxdrostat)
o Systemic mineralocorticoid replacement therapy (example. fludrocortisone)
7. Use of potassium binders (such as sodium zirconium cyclosilicate, patiromer, or sodium
polystyrene sulfonate) within 4 weeks prior to Visit 1 (screening)
8. Hyperkalaemia requiring hospitalization within 12 weeks prior to Visit 1 (screening)
9. Serum potassium more than 5.2 mmol per L measured by the central laboratory at Visit 1 (screening)
(Note: one reassessment of serum potassium is allowed during screening)
10. Impaired renal function, defined as eGFR less than 20 mL per min per 1.73 m2 (CKD-EPI) at Visit 1 (screening) measured by the central laboratory, or on renal replacement therapy. (Note: one reassessment of eGFR is allowed during screening)
11. Known adrenal insufficiency (example Addison disease) or Cushings syndrome
12. Symptomatic hypotension and or a mean SBP less than 100 mmHg at Visit 1 (screening) or up to and including Visit 2 (randomisation).
13. Mean SBP more than equals to 180 mmHg or mean DBP more than equals to 120 mmHg at Visit 1 (screening) or Visit 2 (randomisation).
14. MI or stroke or transient ischemic attack or acute inflammatory heart disease, such as
acute myocarditis or major surgery (major according to the investigators assessment),
within 12 weeks prior to Visit 1 (screening) and until Visit 2 (randomisation) or planned
major elective surgery (e.g. hip replacement, CABG)
15. Percutaneous vascular intervention or any angiography using iodinated contrast agents in the 1 week prior to Visit 2 (randomisation)
16. Known severe valvular heart disease (obstructive or regurgitant) except mitral
regurgitation secondary to left ventricular dilatation, as per investigators judgement, or
valvular heart disease scheduled for surgical or invasive procedures at Visit 1 (screening),
or anticipated invasive treatment during the study
17. ALT or AST more than 3 times ULN as measured by central lab at Visit 1 (screening)
18. Known severe hepatic impairment (example. Child Pugh class C cirrhosis)
19. Gastrointestinal surgery or gastrointestinal disorder that could interfere with trial
medication absorption in the investigators opinion example. intestinal resection, inflammatory bowel disease, currently active gastritis, pancreatitis
20. Type 1 diabetes mellitus or history of other autoimmune causes of diabetes mellitus (example. LADA) or uncontrolled T2DM (HbA1c more than 10 percent as measured by the central lab) at Visit 1 (screening)
21. History of ketoacidosis within 5 years prior to Visit 1 (screening) or until Visit 2
(randomisation)
22. Any documented active or suspected malignancy or history of malignancy within 5 years prior to Visit 1 (screening), except appropriately treated basal cell carcinoma of the skin, in situ carcinoma of uterine cervix or low risk prostate cancer (patients with pre-treatment PSA less than 10 ng per mL and biopsy Gleason score of less than equals to 6 and clinical stage T1c or T2a)
23. Participants who must or wish to continue the intake of restricted medications (see
Section 4.2.2.1) or any drug considered likely to interfere with the safe conduct of the
trial
24. Participants not expected to comply with the protocol requirements or not expected to complete the trial as scheduled (e.g. chronic alcohol or drug abuse or any other condition that, in the investigators opinion, makes the participant an unreliable trial participant)
25. Previous randomization in this trial
26. Currently enrolled in another investigational device or drug trial, or less than 30 days
from Visit 1 (screening) since ending another investigational device or drug trial(s) or
receiving other investigational treatment(s). Those patients participating in a purely
observational trial will not be excluded
27. Women who are pregnant, breastfeeding, or plan to become pregnant while in the trial
28. Any condition not covered by any of the other exclusion criteria which, in the
investigators opinion, might jeopardise the participants safety or compliance with the
protocol.
29. Any vulnerable person (defined as: pregnant or breastfeeding women; persons deprived of their liberty; minors; persons that may have insufficient power, intelligence, education, resources, strength, or other needed attributes to protect their own interests; or unable to explicitly give consent), as per local regulation.
30. Intolerance or known allergy or hypersensitivity to vicadrostat or empagliflozin or other SGLT2 inhibitors and or any of the excipients (including lactose). A list of ingredients of vicadrostat and empagliflozin and vicadrostat-placebo is provided in the IB.

Method of Generating Random Sequence

Other

Method of Concealment

Other

Blinding/Masking

Participant and Investigator Blinded

Primary Outcome

Outcome	TimePoints
To demonstrate the superiority of the combination of vicadrostat 10 mg and empagliflozin 10 mg compared with vicadrostat-placebo and empagliflozin 10 mg for the time to first CV death, hospitalisation for heart failure (HHF), or urgent heart failure (HF) visit in participants with T2DM with HTN and established CVD	week 24

Secondary Outcome

Outcome

TimePoints

to demonstrate the superiority of the combination of vicadrostat 10 mg and empagliflozin 10 mg compared with vicadrostat-placebo and empagliflozin 10 mg for the
time to first event of CV death or HHF, absolute change from baseline in mean SBP at Week 24, relative change from baseline in UACR at Week 24, time to first occurrence of the composite outcome of kidney disease progression or HHF or CV death, time to first event of 4P-MACE, occurrences of all-cause hospitalisations (first and recurrent), time to first event of new-onset atrial fibrillation or atrial flutter (in participants without history of atrial fibrillation and atrial flutter) or CV death, and time to all-cause death

week 24

Target Sample Size

Total Sample Size="11800"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

Phase 3

Date of First Enrollment (India)

29/01/2026

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

23/07/2025

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="1"
Months="4"
Days="0"

Recruitment Status of Trial (Global)

Open to Recruitment

Recruitment Status of Trial (India)

Open to Recruitment

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

Despite recent advances in the management of type 2 diabetes mellitus (T2DM), chronic kidney disease (CKD), and hypertension (HTN), an unmet need for effective therapies remains, especially for T2DM patients with comorbid arterial HTN and established cardiovascular disease (CVD). It is hypothesized that lowering plasma aldosterone by direct inhibition of the aldosterone synthase (AS) has the potential for therapeutic benefit in reduction of CV death and heart failure events (HFE) in T2DM patients with HTN and established CVD through moderation of both aldosterone mediated MR-dependent and MR-independent action. The combination of vicadrostat and empagliflozin may achieve an

additive beneficial effect on CV outcomes in participants with established T2DM, HTN, and CVD. Therefore, the aim of the EASi™-PROTKT trial is to assess the efficacy and safety of the combination of vicadrostat 10 mg and empagliflozin 10 mg compared with vicadrostat-placebo plus empagliflozin 10 mg on occurrence of CV outcomes, mainly CV death and HFE, in addition to assessment of impact on systolic blood pressure (SBP), urine albumin creatinine ratio (UACR), first occurrence of the composite outcome of kidney disease progression, HHF or CV death, 4 pointmajor adverse cardiovascular events (4P-MACE), all-causehospitalizations, new-onset atrial fibrillation or atrial flutter (in participants without history of atrial fibrillation and atrial flutter) or CV death, and all-cause death.