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

Last updated: September 22, 2025
Sponsor: AstraZeneca
Overall Status: Terminated

Phase

1

Condition

Chest Pain

Congestive Heart Failure

Nephropathy

Treatment

Placebo

AZD5462

Dapagliflozin

Clinical Study ID

NCT06639087
D9090C00007
2024-513142-11-00
  • Ages 18-85
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 onechocardiography taken within the last 9 months.

  • Participants must have an estimated glomerular filtration rate (eGFR) of 30 to 60milliliters per minute per 1.73 meters squared (mL/min/1.73 m2) (inclusive) atScreening 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 4weeks prior to Screening. If the participant is currently taking diuretics, thendiuretics 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

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 ofthe excipients of these drug products.

  • Congenital long QT syndrome or history of QT prolongation associated with othermedications that required discontinuation of that medication.

  • Cardiac ventricular arrhythmia that requires treatment. However, participants withatrial fibrillation or flutter and controlled ventricular rate (eg, resting heartrate < 110 beats per minute) are permitted. Participants with cardiac ventriculararrhythmia that are treated with antiarrhythmic agents (eg, amiodarone) and arestable are permitted.

  • History of or anticipated heart transplant.

  • Any planned highly invasive cardiovascular procedure (eg, coronaryrevascularisation, valve repair/replacement, aortic aneurysm surgery).

  • Any evidence of clinically important disease or disorder which in the Investigator'sopinion makes it undesirable for the participant to participate in the study.

  • Positive hepatitis C antibody, hepatitis B virus surface antigen, or hepatitis Bvirus core antibody at Screening.

Study Design

Total Participants: 8
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 1
Study Start date:
September 27, 2024
Estimated Completion Date:
May 29, 2025

Study 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)

Connect with a study center

  • Research Site

    Sofia, 1612
    Bulgaria

    Site Not Available

  • Research Site

    Sofia 727011, 1612
    Bulgaria

    Site Not Available

  • Research Site

    Mölndal, SE-431 53
    Sweden

    Site Not Available

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