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Evaluating AZD5462 for Chronic Heart Failure

A Phase IIb Two-Cohort, Randomised, Placebo-controlled, Double-blind, Multi-centre, Dose-ranging Study of AZD5462 in Stable Patients With Chronic Heart Failure

Phase 2 Interventional AstraZeneca · NCT06299826

This study is testing if a new medication called AZD5462 can improve heart function in people with chronic heart failure while they continue their usual treatments.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment360 (estimated)
Ages18 Years to 85 Years
SexAll
SponsorAstraZeneca Industry-sponsored
Locations60 sites (Alexander City, Alabama and 59 other locations)
Trial IDNCT06299826 on ClinicalTrials.gov

What this trial studies

This Phase IIb study aims to assess the effects of AZD5462, a Relaxin Family Peptide Receptor 1 (RXFP1) agonist, on cardiac function in patients with chronic heart failure. Participants will be randomized to receive either AZD5462 at varying doses or a placebo, in addition to their standard heart failure medications. The study consists of a screening period, a 24-week treatment phase, and a follow-up period, with multiple study visits to monitor efficacy and safety.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with chronic heart failure classified as NYHA functional class II to IV who are stable on standard heart failure medications.

Not a fit: Patients with significant comorbid conditions or those not meeting the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve cardiac function and overall health outcomes for patients with chronic heart failure.

How similar studies have performed: Previous studies involving RXFP1 agonists have shown promise, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Participants must have a pre-existing diagnosis of HF NYHA FC II to IV.
* Participants must be on stable HF standard of care medication for at least 4 weeks prior to consent and during the Screening period.
* Minimum body mass index (BMI) of 18 kilograms per meter square (kg/m\^2) at Screening.
* For female participants, the participant must not be pregnant or lactating and must be of non-childbearing potential.
* All male participants should refrain from fathering a child or donating sperm until 3 months after the final study Follow-up Visit. Non-sterilised male participants should avoid fathering a child either by true abstinence or use of a condom for all sexual intercourse with a female partner of childbearing potential from the first dose until 3 months after the final Follow-up Visit.

Exclusion Criteria:

* Historical or current evidence of a clinically significant disease or disorder including, but not limited to:

  1. Myocardial infarction, stroke, transient ischaemic attack, coronary artery bypass grafting, or percutaneous coronary intervention within 12 weeks prior to consent or transcatheter structural heart interventions or cardiac valve surgery within 6 months prior to consent.
  2. Sarcoidosis, restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, or hypertrophic (obstructive) cardiomyopathy.
  3. History of untreated clinically significant valve disease or a Screening confirmation of severe aortic stenosis, severe mitral stenosis, moderate or severe aortic insufficiency or severe mitral insufficiency.
  4. Amyloidosis, Fabry disease, or haemochromatosis.
  5. Pericardial disease (i.e., visually significant white pericardium on echocardiogram).
  6. Known coagulation disorders.
  7. Current diagnosis of active hepatitis.
  8. Severe pulmonary disease that is not expected to improve over time, as assessed by the investigator.
  9. Decompensated HF or any cardiopulmonary hospitalisation, except planned hospitalisation without worsening of cardiac or pulmonary functions, within 4 weeks prior to consent or during the Screening period.
  10. History of active malignancy within 2 years, except for fully excised or treated basal cell carcinoma, or ≤ 2 squamous cell carcinomas of the skin and participants who are under investigation for breast or cervical cancer, including participants with a pap smear of grade ≥ 3.
* History of hypersensitivity to AZD5462 or any component of AZD5462 drug product.
* Known history of drug or alcohol abuse within 24 months of Screening.
* 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.
* History of or anticipated heart transplant.
* Current or planned cardiac resynchronization therapy/bi-ventricular pacemaker or mechanical assist device implantation.
* Any planned highly invasive cardiovascular procedure (eg, coronary revascularisation, ablation of atrial fibrillation/flutter etc).
* Positive hepatitis C antibody, or hepatitis B virus surface antigen at Screening. Participants with positive hepatitis B virus core antibody can be included in the study as long as hepatitis B virus surface antigen is negative, and there are no other signs of an active hepatitis B.
* Known to have historically tested positive for Human Immunodeficiency Virus.

Where this trial is running

Alexander City, Alabama and 59 other locations

+10 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Heart FailureRelaxin Family Peptide Receptor 1 agonist
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.