A Phase IIb Study of AZD5462 in Patients With Chronic Heart Failure
NCT ID: NCT06299826
Last Updated: 2025-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
375 participants
INTERVENTIONAL
2024-06-04
2026-02-24
Brief Summary
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Detailed Description
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The study will include 3 periods and approximately 12 study visits:
* Screening period of up to 4 weeks (at least 1 study visit)
* Treatment period of 24 weeks (8 study visits)
* Follow-up period of 4 weeks (3 study visits)
Eligible participants in each cohort will be randomized equally 1:1:1:1 to receive a once daily dose (OD) of 3 dose levels (low, medium, or high) oral dose of AZD5462 tablets or placebo.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Cohort A & B: AZD5462 low dose
Participants will receive low dose of AZD5462 as OD tablets for 24 weeks.
AZD5462
Participants will receive low, medium \& high doses of film-coated tablets of AZD5462 OD orally.
Cohort A & B: AZD5462 medium dose
Participants will receive medium dose of AZD5462 as OD tablets for 24 weeks.
AZD5462
Participants will receive low, medium \& high doses of film-coated tablets of AZD5462 OD orally.
Cohort A & B: AZD5462 high dose
Participants will receive high dose of AZD5462 as OD tablets for 24 weeks.
AZD5462
Participants will receive low, medium \& high doses of film-coated tablets of AZD5462 OD orally.
Cohort A & B: Placebo
Participants will receive matching placebo OD tablets for 24 weeks.
Placebo
Participants will receive matching doses of film-coated tablets of Placebo OD orally.
Interventions
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AZD5462
Participants will receive low, medium \& high doses of film-coated tablets of AZD5462 OD orally.
Placebo
Participants will receive matching doses of film-coated tablets of Placebo OD orally.
Eligibility Criteria
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Inclusion Criteria
* 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
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.
18 Years
85 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Alexander City, Alabama, United States
Research Site
Northridge, California, United States
Research Site
Torrance, California, United States
Research Site
Vista, California, United States
Research Site
Miami, Florida, United States
Research Site
Miami Beach, Florida, United States
Research Site
Richmond, Indiana, United States
Research Site
Boston, Massachusetts, United States
Research Site
Buffalo, New York, United States
Research Site
Rosedale, New York, United States
Research Site
Chapel Hill, North Carolina, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Knoxville, Tennessee, United States
Research Site
Manassas, Virginia, United States
Research Site
Pleven, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Brno, , Czechia
Research Site
Jaroměř, , Czechia
Research Site
Liberec, , Czechia
Research Site
Louny, , Czechia
Research Site
Pilsen, , Czechia
Research Site
Aalborg, , Denmark
Research Site
Herning, , Denmark
Research Site
Balatonfüred, , Hungary
Research Site
Kistarcsa, , Hungary
Research Site
Nyíregyháza, , Hungary
Research Site
Székesfehérvár, , Hungary
Research Site
Kochi, , India
Research Site
Kolkata, , India
Research Site
Surat, , India
Research Site
Vadodara, , India
Research Site
Fukui-shi, , Japan
Research Site
Higashiibaraki-gun, , Japan
Research Site
Higashiohmi-shi, , Japan
Research Site
Kitakyushu, , Japan
Research Site
Kobe, , Japan
Research Site
Kumamoto, , Japan
Research Site
Miyazaki, , Japan
Research Site
Morioka, , Japan
Research Site
Naha, , Japan
Research Site
Ōmihachiman, , Japan
Research Site
Shūnan, , Japan
Research Site
Breda, , Netherlands
Research Site
Deventer, , Netherlands
Research Site
Enschede, , Netherlands
Research Site
Krakow, , Poland
Research Site
Krakow, , Poland
Research Site
Lodz, , Poland
Research Site
Warsaw, , Poland
Research Site
Wroclaw, , Poland
Research Site
Wroclaw, , Poland
Research Site
Bratislava, , Slovakia
Research Site
Bratislava, , Slovakia
Research Site
Košice, , Slovakia
Countries
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Other Identifiers
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2023-510148-19-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
D9090C00008
Identifier Type: -
Identifier Source: org_study_id
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