A Phase IIb Study of AZD5462 in Patients With Chronic Heart Failure

NCT06299826 | Completed Phase 2 FDA Drug

• 2 other identifiers: D9090C000082023-510148-19-00
• Study Type: interventional
• Target: 375
• Locations: 10 countries
• Sites: 56

Brief Summary

The main purpose of this study is to evaluate the effect of AZD5462 on cardiac function in participants with chronic heart failure (HF).

Conditions

Chronic Heart Failure

Keywords

Relaxin Family Peptide Receptor 1 (RXFP1) agonist

Outcome Measures

Primary Outcomes (1)

• Cohort A and B: Change from Baseline in Echocardiography Parameters

  To evaluate the effect of AZD5462 after treatment in participants with HF.

  From Baseline to Week 25

Secondary Outcomes (6)

• Cohort A and B: Change from Baseline in Echocardiography Parameters

  From Baseline to Week 13 and Week 25

• Cohorts A and B: Change from Baseline in Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OSS)

  From Baseline to Weeks 3, 5, 13, and 25

• Cohorts A and B: Change from Baseline in New York Heart Association Functional Class (NYHA FC)

  Baseline and Week 25

• Cohorts A and B: Change from Baseline in cardiac biomarkers

  From Baseline to Weeks 5, 13, and 25

• Cohorts A and B : Plasma Concentration of AZD5462

  Day 15 (Week 3), Day 29 (Week 5) and 85 (Week 13)

Study Arms (4)

Cohort A & B: AZD5462 low dose

EXPERIMENTAL

Participants will receive low dose of AZD5462 as OD tablets for 24 weeks.

Drug: AZD5462

Cohort A & B: AZD5462 medium dose

EXPERIMENTAL

Participants will receive medium dose of AZD5462 as OD tablets for 24 weeks.

Drug: AZD5462

Cohort A & B: AZD5462 high dose

EXPERIMENTAL

Participants will receive high dose of AZD5462 as OD tablets for 24 weeks.

Drug: AZD5462

Cohort A & B: Placebo

EXPERIMENTAL

Participants will receive matching placebo OD tablets for 24 weeks.

Drug: Placebo

Interventions

Placebo DRUG

Participants will receive matching doses of film-coated tablets of Placebo OD orally.

Cohort A & B: Placebo

AZD5462 DRUG

Participants will receive low, medium \& high doses of film-coated tablets of AZD5462 OD orally.

Cohort A & B: AZD5462 high dose; Cohort A & B: AZD5462 low dose; Cohort A & B: AZD5462 medium dose

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 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.

You may not qualify if:

• Historical or current evidence of a clinically significant disease or disorder including, but not limited to:
• 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.
• Sarcoidosis, restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, or hypertrophic (obstructive) cardiomyopathy.
• 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.
• Amyloidosis, Fabry disease, or haemochromatosis.
• Pericardial disease (i.e., visually significant white pericardium on echocardiogram).
• Known coagulation disorders.
• Current diagnosis of active hepatitis.
• Severe pulmonary disease that is not expected to improve over time, as assessed by the investigator.
• 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.
• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (56)

Research Site

Alexander City, Alabama, 35010, United States

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Northridge, California, 91325, United States

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Torrance, California, 90502, United States

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Vista, California, 92081, United States

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Miami, Florida, 33133, United States

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Miami Beach, Florida, 33140, United States

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Richmond, Indiana, 47374, United States

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Boston, Massachusetts, 02114, United States

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Buffalo, New York, 14215, United States

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Rosedale, New York, 11422, United States

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Chapel Hill, North Carolina, 27599, United States

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Philadelphia, Pennsylvania, 19107, United States

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Knoxville, Tennessee, 37916, United States

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Manassas, Virginia, 20109, United States

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Pleven, 5800, Bulgaria

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Sofia, 1309, Bulgaria

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Sofia, 1431, Bulgaria

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Sofia, 1527, Bulgaria

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Brno, 625 00, Czechia

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Jaroměř, 55101, Czechia

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Liberec, 460 01, Czechia

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Louny, 440 01, Czechia

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Pilsen, 301 00, Czechia

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Aalborg, 9000, Denmark

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Herning, 7400, Denmark

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Balatonfüred, 8230, Hungary

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Kistarcsa, 2143, Hungary

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Nyíregyháza, 4400, Hungary

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Székesfehérvár, 8000, Hungary

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Kochi, 682018, India

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Kolkata, 700020, India

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Surat, 395001, India

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Vadodara, 390022, India

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Fukui-shi, 910-8526, Japan

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Higashiibaraki-gun, 311-3193, Japan

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Higashiohmi-shi, 527-8505, Japan

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Kitakyushu, 802-8555, Japan

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Kobe, 654-0155, Japan

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Kumamoto, 861-4193, Japan

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Miyazaki, 880-0834, Japan

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Morioka, 020-0066, Japan

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Naha, 902-8511, Japan

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Ōmihachiman, 523-0082, Japan

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Shūnan, 745-8522, Japan

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Breda, 4818 CK, Netherlands

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Deventer, 7416 SE, Netherlands

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Enschede, 7512 KZ, Netherlands

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Krakow, 30-082, Poland

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Krakow, 31-271, Poland

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Lodz, 93-513, Poland

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Warsaw, 01-249, Poland

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Wroclaw, 50-556, Poland

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Wroclaw, 50-981, Poland

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Bratislava, 813 69, Slovakia

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Bratislava, 821 07, Slovakia

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Košice, 044 24, Slovakia

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: March 8, 2024
• Study Start: June 4, 2024
• Primary Completion: February 10, 2026
• Study Completion: February 10, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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 refer 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 environmentVivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

HU (4); SL (3); DK (2); PL (6); BU (4); JP (11); IN (4); US (14); CZ (5); NL (3)