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:NCT06639087

EudraCT identifier:N/A

CTIS identifier:2024-513142-11-00

Study Complete

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

Actual Enrollment

Study type

Interventional

Age

18 Years - 85 Years

Date

Study Start Date: 27 Sept 2024

Primary Completion Date: 29 May 2025

Study Completion Date: 29 May 2025

Study design

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

Verification:

Verified 01 Jun 2025 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 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.

Location

Research Site

Sofia, Bulgaria, 1612

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.

"There is no result for the study"

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Trial Results Summaries