A Study of AZD3427 in Participants With Heart Failure and Pulmonary Hypertension Group 2
NCT ID: NCT05737940
Last Updated: 2025-09-24
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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COMPLETED
PHASE2
260 participants
INTERVENTIONAL
2023-04-24
2025-08-25
Brief Summary
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Detailed Description
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Approximately 220 participants will be randomised to 4 treatment groups (in a 1:1:1:1 ratio) to receive a subcutaneous (SC) injection of AZD3427 or placebo every 2 weeks for 24 weeks.
This study will evaluate 3 dose levels of AZD3427: Dose A, Dose B, and Dose C. Dose modification is not applicable for this study.
The study will be conducted in approximately 60 study centres across an estimated 15 countries.
The study will include approximately 16 study visits: 2 visits during the Screening Period,13 visits during the Treatment Period, and one visit during the Follow-up Period.
The expected total duration of the study is 32 to 37 weeks, depending on the length of the Screening Period.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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AZD3427 Dose A
The participants will receive single dose of AZD3427 Dose A every 2 weeks for 24 weeks from Day 1 to Day 155.
AZD3427
The participants will receive AZD3427 SC injection single dose of either Dose A or Dose B or Dose C every 2 weeks for 24 weeks.
AZD3427 Dose B
The participants will receive single dose of AZD3427 Dose B every 2 weeks for 24 weeks from Day 1 to Day 155.
AZD3427
The participants will receive AZD3427 SC injection single dose of either Dose A or Dose B or Dose C every 2 weeks for 24 weeks.
AZD3427 Dose C
The participants will receive single dose of AZD3427 Dose C every 2 weeks for 24 weeks from Day 1 to Day 155.
AZD3427
The participants will receive AZD3427 SC injection single dose of either Dose A or Dose B or Dose C every 2 weeks for 24 weeks.
Placebo
The participants will receive single dose of placebo every 2 weeks for 24 weeks from Day 1 to Day 155.
Placebo
The participants will receive SC injection of placebo single dose every 2 weeks for 24 weeks.
Interventions
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AZD3427
The participants will receive AZD3427 SC injection single dose of either Dose A or Dose B or Dose C every 2 weeks for 24 weeks.
Placebo
The participants will receive SC injection of placebo single dose every 2 weeks for 24 weeks.
Eligibility Criteria
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Inclusion Criteria
2. Participants must have a pre-existing diagnosis of HF, NYHA function class (FC) II to IV, and a pre-existing diagnosis of PH-LHD or likely or intermediate probability of Pulmonary hypertension due to left heart disease (PH-LHD) as per 2022 Pulmonary hypertension due to left heart disease European Society of Cardiology/European Respiratory Society (ESC/ERS) guidelines. Participants must be on stable HF standard of care medication, including diuretics.
3. Participants must have a combination of echocardiographic parameters that show intermediate or high probability of PH as per 2022 ESC/ERS guidelines.
4. Participants must have an on-study elevated pulmonary artery pressure from RHC performed as per RHC manual provided by the Sponsor, at Screening Visit 2:
1. PAWP ≥ 15 mmHg
2. mPAP ≥ 20 mmHg
5. Minimum body weight of 45 kg (inclusive).
6. Capable and willing of giving signed informed consent.
Exclusion Criteria
2. Historical or current evidence of a clinically significant disease or disorder.
3. Decompensated HF or hospitalisation due to decompensated HF.
4. Any contraindications to RHC.
5. History of hypersensitivity to SC injections or devices.
6. History of hypersensitivity to drugs with a similar chemical structure or class to AZD3427 or any component of AZD3427 drug product, or ongoing clinically important allergy/hypersensitivity.
7. Known lung disease with Forced expiratory volume in the first second (FEV1) \< 30% of predicted.
8. Congenital long QT syndrome.
9. Cardiac ventricular arrhythmia which requires treatment. Participants with atrial fibrillation or flutter and controlled ventricular rate are permitted.
10. History of or anticipated heart transplant or ventricular assist device implantation.
11. Any known planned (scheduled) highly invasive Cardiovascular (CV) procedure (eg, coronary revascularisation, ablation of atrial fibrillation/flutter, valve repair/replacement, aortic aneurysm surgery, etc).
12. Participants who have previously received AZD3427.
18 Years
130 Years
ALL
No
Sponsors
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Parexel
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Beverly Hills, California, United States
Research Site
La Jolla, California, United States
Research Site
New Haven, Connecticut, United States
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Baltimore, Maryland, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Rock Hill, South Carolina, United States
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Linz, , Austria
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Vienna, , Austria
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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Halifax, Nova Scotia, Canada
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London, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Beijing, , China
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Changsha, , China
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Guangzhou, , China
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Kunming, , China
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Aarhus, , Denmark
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Copenhagen, , Denmark
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Berlin, , Germany
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Cologne, , Germany
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Frankfurt, , Germany
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Jena, , Germany
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Brescia, , Italy
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Genoa, , Italy
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Marche, , Italy
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Milan, , Italy
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Milan, , Italy
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Trieste, , Italy
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Bunkyō City, , Japan
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Kasugai-shi, , Japan
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Kure-shi, , Japan
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Nagoya, , Japan
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Sapporo, , Japan
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Sunto-gun, , Japan
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Toyama, , Japan
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Deventer, , Netherlands
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Heerlen, , Netherlands
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Tilburg, , Netherlands
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Bialystok, , Poland
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Gdansk, , Poland
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Krakow, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Majadahonda, , Spain
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Seville, , Spain
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Toledo, , Spain
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Valencia, , Spain
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Gothenburg, , Sweden
Research Site
Huddinge, , Sweden
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Cambridge, , United Kingdom
Research Site
Clydebank, , United Kingdom
Research Site
London, , United Kingdom
Countries
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Other Identifiers
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D8330C00003
Identifier Type: -
Identifier Source: org_study_id
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