Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin

Inclusion Criteria:

1. Participants of any sex and gender must be ≥ 40 years old at the time of signing theinformed consent.

2. Diagnosed with T2DM and requiring treatment

3. Established CV disease (ischaemic heart disease, cerebrovascular disease, peripheralarterial disease)

4. History of HTN and an SBP ≥ 130 mmHg at screening and ≥ 120 mmHg at theRandomisation Visit.

5. Central laboratory serum potassium must meet the following criteria at the Screening Visit, based on screening eGFR:

• for participants with screening eGFR ≥ 45 mL/min/1.73 m2, potassium must be ≥ 3.0 and ≤ 4.8 mmol/L at the Screening Visit

• for participants with screening eGFR < 45 mL/min/1.73 m2, potassium must be ≥ 3.0 and ≤ 4.5 mmol/L at the Screening Visit

6. At least one additional risk factor for HF:

• Age ≥ 70 years

• UACR > 20 mg/g

• eGFR < 60 mL/min/1.73 m2

• History of polyvascular disease (at least two of: ischaemic heart disease,cerebrovascular disease, and peripheral arterial disease)

• History of atrial fibrillation or atrial flutter

• NT-proBNP > 125 ng/L

Exclusion Criteria:

1. Previously confirmed diagnosis and treatment of heart failure

2. An eGFR < 30 mL/min/1.73 m2 at screening

3. Known hyperkalaemia, defined as potassium ≥ 5.5 mmol/L within 3 months prior toscreening

4. Type 1 diabetes mellitus or uncontrolled T2DM with HbA1c > 10.5% (> 91 mmol/mol) atscreening

5. Serum sodium < 135 mmol/L at screening, determined as per central laboratoryassessment

6. Stroke, transient ischaemic cerebral attack, valve implantation or valvereplacement, carotid surgery, carotid angioplasty, or cardiac surgery, within 3months prior to randomisation

7. Myocardial infarction within 3 months prior to randomisation, or within 1 monthprior to randomisation when there is no further planned revascularisation

8. Percutaneous coronary intervention within 1 month prior to randomisation

9. Known severe hepatic impairment, defined as Child-Pugh Class C, based on recordsthat confirm documented medical history

10. Documented history of adrenal insufficiency

11. Any dialysis (including for acute kidney injury) within 3 months prior to screening

12. Any acute kidney injury within 3 months prior to screening

13. History or known allergy/hypersensitivity to the study treatment, as judged by theInvestigator (eg, SGLT2i or active substance or excipients)

14. History of organ transplant or bone marrow transplant, or planned organ transplantwithin 6 months following randomisation (including kidney transplant)

15. Any clinical condition requiring systemic immunosuppression therapy other thanmaintenance therapy (stable for at least 3 months prior to screening)

16. Drug or alcohol abuse that in the Investigator's judgement makes the participant apoor candidate for the study

17. Any use of mineralocorticoid receptor antagonists (such as spironolactone,eplerenone, or finerenone) or aldosterone synthase inhibitor within 4 weeks prior toscreening and/or during the study

18. Concomitant therapy with strong inducers of cytochrome P450

19. Use of potassium-sparing diuretics (such as triamterene or amiloride) and directrenin inhibitor (eg, aliskiren) at the time of screening

20. Use of potassium binders (such as sodium zirconium cyclosilicate, patiromer, orsodium polystyrene sulfonate) within 4 weeks prior to screening