A Phase Ib Study of AZD5462 on Top of Dapagliflozin in Participants With Heart Failure and Moderate Renal Impairment

NCT ID: NCT06639087

Last Updated: 2025-09-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-27
• Study Completion Date: 2025-05-29

Brief Summary

A study to investigate the effects and safety of AZD5462 on top of dapagliflozin in participants with heart failure and moderate renal impairment.

Detailed Description

This is a randomized, double-blind, placebo-controlled Phase 1b study to evaluate the safety, pharmacodynamics, and pharmacokinetics of AZD5462 on top of dapagliflozin in participants with heart failure and renal impairment.

The study will include 5 periods and approximately 9 study site visits:

• Screening Period of up to 4 weeks (at least one study visit)
• Run-in Period of up to 4 weeks (one study visit)
• Inpatient Treatment Period of 4 days (one study visit)
• Outpatient Treatment Period of up to 4 weeks (three study visits)
• Follow-up Period of up to 4 weeks (three study visits)

Conditions

Renal Impairment; Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

AZD5462 + dapagliflozin

Participants will receive AZD5462 on top of dapagliflozin once daily.

Group Type: ACTIVE_COMPARATOR

AZD5462

Intervention Type: DRUG

Participants will receive AZD5462 on top of dapagliflozin once daily.

Dapagliflozin

Intervention Type: DRUG

Participants will receive dapagliflozin once daily with AZD5462 or placebo.

Placebo + dapagliflozin

Participants will receive placebo on top of dapagliflozin once daily.

Group Type: PLACEBO_COMPARATOR

Dapagliflozin

Intervention Type: DRUG

Participants will receive dapagliflozin once daily with AZD5462 or placebo.

Placebo

Intervention Type: OTHER

Participants will receive placebo on top of dapagliflozin once daily.

Interventions

AZD5462

Participants will receive AZD5462 on top of dapagliflozin once daily.

Intervention Type: DRUG

Dapagliflozin

Participants will receive dapagliflozin once daily with AZD5462 or placebo.

Intervention Type: DRUG

Placebo

Participants will receive placebo on top of dapagliflozin once daily.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Parexel

INDUSTRY

Sponsor Role: collaborator

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Site

Sofia, , Bulgaria

Countries

Bulgaria

Other Identifiers

2024-513142-11-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

D9090C00007

Identifier Type: -

Identifier Source: org_study_id