Chronic Heart FailurePhase 2LUMINARANCT06299826
A Phase IIb Study of AZD5462 in Patients With Chronic Heart Failure
A Phase 2 study testing AZD5462 in people with Chronic Heart Failure, run by AstraZeneca at 57 sites in 10 countries.
Trial summary
The main purpose of this study is to evaluate the effect of AZD5462 on cardiac function in participants with chronic heart failure (HF). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- AZD5462
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 375 participants
- Where
- 57 sitesin 10 countries
- Study dates
- 4 Jun 2024to 10 Feb 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
- 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.
Trial locations and contacts
57 sites in 10 countries.
57 sites in 10 countries
United States14 sites
Research Site
Alexander City, Alabama, 35010
Research Site
Boston, Massachusetts, 02114
Research Site
Buffalo, New York, 14215
Research Site
Chapel Hill, North Carolina, 27599
Research Site
Knoxville, Tennessee, 37916
Research Site
Manassas, Virginia, 20109
Research Site
Miami, Florida, 33133
Research Site
Miami Beach, Florida, 33140
Research Site
Northridge, California, 91325
Research Site
Philadelphia, Pennsylvania, 19107
Research Site
Richmond, Indiana, 47374
Research Site
Rosedale, New York, 11422
Research Site
Torrance, California, 90502
Research Site
Vista, California, 92081
Japan11 sites
Research Site
Fukui-shi, 910-8526
Research Site
Higashiibaraki-gun, 311-3193
Research Site
Higashiohmi-shi, 527-8505
Research Site
Kitakyushu, 802-8555
Research Site
Kobe, 654-0155
Research Site
Kumamoto, 861-4193
Research Site
Miyazaki, 880-0834
Research Site
Morioka, 020-0066
Research Site
Naha, 902-8511
Research Site
Ōmihachiman, 523-0082
Research Site
Shūnan, 745-8522
Poland6 sites
Research Site
Krakow, 30-082
Research Site
Krakow, 31-271
Research Site
Lodz, 93-513
Research Site
Warsaw, 01-249
Research Site
Wroclaw, 50-556
Research Site
Wroclaw, 53-114
Bulgaria5 sites
Research Site
Pleven, 5800
Research Site
Pleven, 5803
Research Site
Sofia, 1309
Research Site
Sofia, 1431
Research Site
Sofia, 1527
Czechia5 sites
Research Site
Brno, 625 00
Research Site
Jaroměř, 55101
Research Site
Liberec, 460 01
Research Site
Louny, 440 01
Research Site
Pilsen, 301 00
Hungary4 sites
Research Site
Balatonfüred, 8230
Research Site
Kistarcsa, 2143
Research Site
Nyíregyháza, 4400
Research Site
Székesfehérvár, 8000
India4 sites
Research Site
Kochi, 682018
Research Site
Kolkata, 700020
Research Site
Surat, 395001
Research Site
Vadodara, 390022
Netherlands3 sites
Research Site
Breda, 4818 CK
Research Site
Deventer, 7416 SE
Research Site
Enschede, 7512 KZ
Slovakia3 sites
Research Site
Bratislava, 813 69
Research Site
Bratislava, 821 07
Research Site
Košice, 044 24
About this study
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
The main purpose of this study is to evaluate the effect of AZD5462 on cardiac function in participants with chronic heart failure (HF).
Read the detailed description
This is a Phase IIb randomized, double-blind, placebo-controlled, multi-center, dose-ranging study to evaluate the efficacy, safety, and pharmacokinetic (PK) of AZD5462 on top of standard of care in 2 cohorts of participants with HF: Cohort A, and Cohort B.
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
- Chronic Heart Failure
- Being tested
- AZD5462, Placebo
- Keywords
- Relaxin Family Peptide Receptor 1 (RXFP1) agonist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD5462Drug
Participants will receive low, medium \& high doses of film-coated tablets of AZD5462 OD orally.
PlaceboDrug
Participants will receive matching doses of film-coated tablets of Placebo OD orally.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A & B: AZD5462 low dose | Experimental | Participants will receive low dose of AZD5462 as OD tablets for 24 weeks. Receives: Drug: AZD5462 |
| Cohort A & B: AZD5462 medium dose | Experimental | Participants will receive medium dose of AZD5462 as OD tablets for 24 weeks. Receives: Drug: AZD5462 |
| Cohort A & B: AZD5462 high dose | Experimental | Participants will receive high dose of AZD5462 as OD tablets for 24 weeks. Receives: Drug: AZD5462 |
| Cohort A & B: Placebo | Experimental | Participants will receive matching placebo OD tablets for 24 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort A and B: Change from Baseline in Echocardiography Parameters
To evaluate the effect of AZD5462 after treatment in participants with HF.
Measured: From Baseline to Week 25
Secondary outcomes (6)
Cohort A and B: Change from Baseline in Echocardiography Parameters
To evaluate the effect and dose response of AZD5462 and effect on echocardiographic markers related to structural, systolic and diastolic function after treatment in participants with HF.
Measured: 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)
To evaluate the effect of AZD5462 on HF health status in participants with HF.
The KCCQ is a validated questionnaire developed for patients with congestive HF. It is a 23-item, self-administered health status measure that quantifies physical limitations, symptoms, social interference, self-efficacy, and quality of life. Results for each domain are summarized and transformed to a score of 0 to 100 with higher scores indicating better health status.
Measured: 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)
To evaluate the effect of AZD5462 on HF health status in participants with HF.
The NYHA Functional Classification is a system to measure the severity of symptoms of heart failure. It places patients in four categories based on limitations of physical activity, from Class I with no limitation, progressing to Class IV with severe limitations.
Measured: Baseline and Week 25
Cohorts A and B: Change from Baseline in cardiac biomarkers
To evaluate the effect of AZD5462 on biomarkers of cardiac function in treatment participants with HF.
Measured: From Baseline to Weeks 5, 13, and 25
Cohorts A and B : Plasma Concentration of AZD5462
To evaluate the PK of AZD5462 after repeat OD oral dosing in participants with HF.
Measured: Day 15 (Week 3), Day 29 (Week 5) and 85 (Week 13)
Cohorts A and B: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
To evaluate the safety and tolerability of AZD5462 as compared to placebo in participants with HF.
Measured: From Baseline to Week 29 (Day 197)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start4 Jun 2024
- Primary completion10 Feb 2026
- Study completion10 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 375 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299826
- Sponsor's protocol ID
- D9090C00008
- Other IDs
- 2023-510148-19-00, 2023
- Acronym
- LUMINARA
- Status last verified
- Jul 2026
- First submitted
- 16 Feb 2024
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Publications
Januzzi JL Jr, Rosenmeier JB, Ely Pizzato P, Quintana-Hayashi MP, Chan LM, Johannesson P, Bhattacharya CS, Aradi D, Schaap J, Vesely J, Piotrowski G, Kinugawa K, Pettersen D, Lima J, Fredriksson M; LUMINARA Investigators. Oral Relaxin Receptor Agonist AZD5462 in Participants With Chronic Heart Failure: Primary Results From the LUMINARA Trial. Circulation. 2026 Aug 30. doi: 10.1161/CIRCULATIONAHA.126.082763. Online ahead of print.
PubMed 42668430
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06299826
- Acronym / sponsor ID
- LUMINARA / D9090C00008
- Conditions
- Chronic Heart Failure
- Keywords
- Relaxin Family Peptide Receptor 1 (RXFP1) agonist
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2024 (actual)
- Primary completion
- 10 Feb 2026 (actual)
- Study completion
- 10 Feb 2026 (actual)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to evaluate the effect of AZD5462 on cardiac function in participants with chronic heart failure (HF).
Detailed description
This is a Phase IIb randomized, double-blind, placebo-controlled, multi-center, dose-ranging study to evaluate the efficacy, safety, and pharmacokinetic (PK) of AZD5462 on top of standard of care in 2 cohorts of participants with HF: Cohort A, and Cohort B.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort A & B: AZD5462 low dose | Experimental | Drug: AZD5462Participants will receive low dose of AZD5462 as OD tablets for 24 weeks. |
| Cohort A & B: AZD5462 medium dose | Experimental | Drug: AZD5462Participants will receive medium dose of AZD5462 as OD tablets for 24 weeks. |
| Cohort A & B: AZD5462 high dose | Experimental | Drug: AZD5462Participants will receive high dose of AZD5462 as OD tablets for 24 weeks. |
| Cohort A & B: Placebo | Experimental | Drug: PlaceboParticipants will receive matching placebo OD tablets for 24 weeks. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (20 listed)
- Historical or current evidence of a clinically significant disease or disorder including, but not limited to:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD5462Participants will receive low, medium \& high doses of film-coated tablets of AZD5462 OD orally. | Drug | Cohort A & B: AZD5462 high dose, Cohort A & B: AZD5462 low dose, Cohort A & B: AZD5462 medium dose |
| PlaceboParticipants will receive matching doses of film-coated tablets of Placebo OD orally. | Drug | Cohort A & B: Placebo |
Primary outcome
Cohort A and B: Change from Baseline in Echocardiography Parameters
Time frame: From Baseline to Week 25
To evaluate the effect of AZD5462 after treatment in participants with HF.
6 secondary outcomes
Cohort A and B: Change from Baseline in Echocardiography Parameters
Time frame: 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)
Time frame: 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)
Time frame: Baseline and Week 25
Cohorts A and B: Change from Baseline in cardiac biomarkers
Time frame: From Baseline to Weeks 5, 13, and 25
Cohorts A and B : Plasma Concentration of AZD5462
Time frame: Day 15 (Week 3), Day 29 (Week 5) and 85 (Week 13)
Cohorts A and B: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From Baseline to Week 29 (Day 197)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Derived from this study: PubMed 42668430Januzzi JL Jr, Rosenmeier JB, Ely Pizzato P, Quintana-Hayashi MP, Chan LM, Johannesson P, Bhattacharya CS, Aradi D, Schaap J, Vesely J, Piotrowski G, Kinugawa K, Pettersen D, Lima J, Fredriksson M; LUMINARA Investigators. Oral Relaxin Receptor Agonist AZD5462 in Participants With Chronic Heart Failure: Primary Results From the LUMINARA Trial. Circulation. 2026 Aug 30. doi: 10.1161/CIRCULATIONAHA.126.082763. Online ahead of print.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
57 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD5462 in people with Chronic Heart Failure, run by AstraZeneca at 57 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in United States, Japan, Poland, Bulgaria, Czechia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohort A and B: Change from Baseline in Echocardiography Parameters (time frame: From Baseline to Week 25). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06299826, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.