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

Study identifier:D9090C00007

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:2024-513142-11-00

Recruiting

Official Title

Phase Ib Randomised, Placebo-controlled, Double-blind, Multicentre Study to Assess the Effects and Safety of AZD5462 on top of Dapagliflozin in Participants with Heart Failure and Moderate Renal Impairment

Medical condition

Renal Impairment

Phase

Phase 1

Healthy volunteers

Study drug

AZD5462, Dapagliflozin

Sex

All

Estimated Enrollment

Study type

Interventional

Age

18 Years - 85 Years

Date

Study Start Date: 27 Sept 2024

Estimated Primary Completion Date: 08 Sept 2025

Estimated Study Completion Date: 08 Sept 2025

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Oct 2024 by AstraZeneca

Collaborators

PAREXEL

Inclusion and exclusion 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 6 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, ablation of atrial fibrillation/flutter, 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.

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Arms	Assigned Interventions
Active Comparator: AZD5462 + dapagliflozin Participants will receive AZD5462 on top of dapagliflozin once daily.	Drug: AZD5462 Participants will receive AZD5462 on top of dapagliflozin once daily. Drug: Dapagliflozin Participants will receive dapagliflozin once daily with AZD5462 or placebo.
Placebo Comparator: Placebo + dapagliflozin Participants will receive placebo on top of dapagliflozin once daily.	Drug: Dapagliflozin Participants will receive dapagliflozin once daily with AZD5462 or placebo. Other: Placebo Participants will receive placebo on top of dapagliflozin once daily.

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]