A Phase IIb Study of AZD5462 in Patients with Chronic Heart Failure - LUMINARA

Study identifier:D9090C00008

ClinicalTrials.gov identifier:NCT06299826

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

Official Title

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

Medical condition

Chronic heart failure

Phase

Phase 2

Healthy volunteers

Study drug

AZD5462, Placebo

Sex

All

Estimated Enrollment

360

Study type

Interventional

Age

18 Years - 85 Years

Date

Study Start Date: 04 Jun 2024

Estimated Primary Completion Date: 24 Nov 2025

Estimated Study Completion Date: 24 Nov 2025

Study design

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

Verification:

Verified 01 Oct 2024 by AstraZeneca

Collaborators

Inclusion and 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:
(a) 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.
(b) Sarcoidosis, restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, or hypertrophic (obstructive) cardiomyopathy.
(c) 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.
(d) Amyloidosis, Fabry disease, or haemochromatosis.
(e) Pericardial disease (i.e., visually significant white pericardium on echocardiogram).
(f) Known coagulation disorders.
(g) Current diagnosis of active hepatitis.
(h) Severe pulmonary disease that is not expected to improve over time, as assessed by the investigator.
(i) Decompensated HF or any cardiopulmonary hospitalisation within 4 weeks prior to consent or during the Screening period.
(j) 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, hepatitis B virus surface antigen or hepatitis B virus core antibody at Screening.
- Known to have historically tested positive for Human Immunodeficiency Virus.

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Arms	Assigned Interventions
Experimental: Cohort A & B: AZD5462 low dose Participants will receive low dose of AZD5462 as OD tablets for 24 weeks.	Drug: AZD5462 Participants will receive low, medium & high doses of film-coated tablets of AZD5462 OD orally.
Experimental: Cohort A & B: AZD5462 medium dose Participants will receive medium dose of AZD5462 as OD tablets for 24 weeks.	Drug: AZD5462 Participants will receive low, medium & high doses of film-coated tablets of AZD5462 OD orally.
Experimental: Cohort A & B: AZD5462 high dose Participants will receive high dose of AZD5462 as OD tablets for 24 weeks.	Drug: AZD5462 Participants will receive low, medium & high doses of film-coated tablets of AZD5462 OD orally.
Experimental: Cohort A & B: Placebo Participants will receive matching placebo OD tablets for 24 weeks.	Drug: Placebo Participants will receive matching doses of film-coated tablets of Placebo OD orally.

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]