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

NCT06639087 | Terminated Phase 1

• 2 other identifiers: D9090C000072024-513142-11-00
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Impairment; Heart Failure

Keywords

Relaxin family peptide receptor 1 agonist; Estimated glomerular filtration rate; Heart failure; Renal impairment

Outcome Measures

Primary Outcomes (1)

• Change in sodium excretion

  To evaluate the effect of AZD5462 on top of dapagliflozin in participants with heart failure (HF) and renal impairment.

  From Baseline to Day 1

Secondary Outcomes (3)

• Change in urine albumin-creatinine ratio (uACR)

  From Baseline to Day 1 and 29

• Change in haematocrit

  From Baseline to Day 29

• Number of adverse events (AEs) and Serious Adverse Events (SAEs)

  From Baseline to Day 57

Study Arms (2)

AZD5462 + dapagliflozin

ACTIVE COMPARATOR

Participants will receive AZD5462 on top of dapagliflozin once daily.

Drug: AZD5462; Drug: Dapagliflozin

Placebo + dapagliflozin

PLACEBO COMPARATOR

Participants will receive placebo on top of dapagliflozin once daily.

Drug: Dapagliflozin; Other: Placebo

Interventions

AZD5462 DRUG

Participants will receive AZD5462 on top of dapagliflozin once daily.

AZD5462 + dapagliflozin

Dapagliflozin DRUG

Participants will receive dapagliflozin once daily with AZD5462 or placebo.

AZD5462 + dapagliflozin; Placebo + dapagliflozin

Placebo OTHER

Participants will receive placebo on top of dapagliflozin once daily.

Placebo + dapagliflozin

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead
• Parexel: collaborator

Study Sites (1)

Research Site

Sofia, 1612, Bulgaria

Location

MeSH Terms

Conditions

Renal Insufficiency; Heart Failure

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: October 15, 2024
• Study Start: September 27, 2024
• Primary Completion: May 29, 2025
• Study Completion: May 29, 2025
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

BU (1)