A phase Ib study of AZD5462 on top of dapagliflozin in participants with heart failure and moderate renal impairment - AURORA

Inclusion Criteria

• Inclusion Criteria:
• - Participants must have a pre-existing diagnosis of heart failure (HF).
• - Participants must have a left ventricular ejection fraction (LVEF) of ≤ 40% based on echocardiography taken within the last 9 months.
• - Participants must have an estimated glomerular filtration rate (eGFR) of 30 to 60 milliliters per minute per 1.73 meters squared (mL/min/1.73 m2) (inclusive) at Screening as assessed by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) 2021 (creatinine) equation.
• - Participants must be on stable HF standard of care (SoC) medication for at least 4 weeks prior to Screening. If the participant is currently taking diuretics, then diuretics must also be stable for at least one week prior to Screening.
• - Participants must be on stable Sodium-glucose co-transporter-2 inhibitors (SGLT2) inhibitor treatment for at least 12 weeks prior to Screening.
• - Minimum BMI of 18 kilograms per meter squared (kg/m2) at Screening.
• Exclusion Criteria:
• - Historical or current evidence of a clinically significant disease or disorder.
• - Participants with a known hypersensitivity to AZD5462 or dapagliflozin, or to any of the excipients of these drug products.
• - Congenital long QT syndrome or history of QT prolongation associated with other medications that required discontinuation of that medication.
• - Cardiac ventricular arrhythmia that requires treatment. However, participants with atrial fibrillation or flutter and controlled ventricular rate (eg, resting heart rate < 110 beats per minute) are permitted. Participants with cardiac ventricular arrhythmia that are treated with antiarrhythmic agents (eg, amiodarone) and are stable are permitted.
• - History of or anticipated heart transplant.
• - Any planned highly invasive cardiovascular procedure (eg, coronary revascularisation, valve repair/replacement, aortic aneurysm surgery).
• - Any evidence of clinically important disease or disorder which in the Investigator’s opinion makes it undesirable for the participant to participate in the study.
• - Positive hepatitis C antibody, hepatitis B virus surface antigen, or hepatitis B virus core antibody at Screening.