In short
Clinical trials are investigating Azd3427 in people with heart failure and related circulation problems. These studies look at whether it can improve blood flow in the lungs and kidneys, and they measure safety and treatment effect in specific patient groups.
Key points
- Azd3427 has been studied in two completed clinical trials. One Phase 2b study looked at adults with heart failure and pulmonary hypertension due to left heart disease, and it measured changes in pulmonary vascular resistance. The other was a small Phase 1b study in patients with heart failure with reduced ejection fraction and renal impairment, focusing on kidney blood flow. Together, these trials show that Azd3427 is being tested in specific heart and kidney-related patient groups. Both studies used placebo comparison, and both are now completed.
Clinical trial overview
Azd3427 has been studied in two interventional trials, both of which are completed. These trials focused on people with heart failure and related problems in blood flow to the lungs or kidneys.
One study was a Phase 2b, randomised, double-blind, placebo-controlled, multi-centre, dose-ranging trial in participants with heart failure and pulmonary hypertension due to left heart disease. The other was a Phase 1b, double-blind, placebo-controlled, randomised trial in patients with heart failure with reduced ejection fraction and renal impairment.
Phase 2b study in pulmonary hypertension
The Phase 2b study, NCT05737940, enrolled 234 participants and was completed. It studied people with heart failure and pulmonary hypertension due to left heart disease, also called WHO Group 2 pulmonary hypertension.
This trial compared Azd3427 with placebo, which is a treatment with no active study drug. It was randomised, meaning participants were assigned by chance, and double-blind, meaning neither the participants nor the study team knew who received which treatment.
The main goal was to see whether Azd3427 changed pulmonary vascular resistance (PVR), which is the resistance blood meets when flowing through the lung vessels. The study measured the change from baseline to Week 25, compared with placebo, using right heart catheterization (RHC), a test that measures pressures inside the heart and lung arteries.
The study was also described as dose-ranging, which means it looked at treatment effects across doses to understand which dose may work best in this patient group.
Phase 1b study in renal perfusion
The Phase 1b study, 2024-513143-82-00, enrolled 12 participants and was completed. It studied patients with heart failure with reduced ejection fraction (HFrEF) and renal impairment, meaning reduced kidney function.
This trial was also randomised, double-blind, and placebo-controlled. The study used positron emission tomography (PET), which is a scan that helps show how an organ is working, to look at kidney blood flow.
The main outcome was the volumetric fraction of the renal cortex, the outer part of the kidney, that had increased perfusion, which means better blood flow. This was measured from baseline to Day 8 and compared with placebo using quantitative parametric mapping on PET.
The brief summary said the study aimed to evaluate the effect of Azd3427 on the volume of perfused renal cortex in participants with HFrEF and reduced eGFR, where eGFR is a lab measure of kidney function.
What the trials measured
In the Phase 2b study, the key endpoint was change in PVR from baseline to Week 25 compared with placebo. This endpoint matters because lower PVR can suggest easier blood flow through the lungs.
In the Phase 1b study, the key endpoint was the share of the kidney cortex with increased perfusion from baseline to Day 8 compared with placebo. This endpoint matters because better kidney perfusion can show that more blood is reaching the kidney tissue being studied.
Both studies used placebo comparison, which helps researchers judge whether the changes seen may be linked to Azd3427 rather than to chance or background care alone.
Who could participate
The studies focused on different patient groups, but both involved people with heart failure and related organ blood flow problems.
- The Phase 2b study included participants with heart failure and pulmonary hypertension due to left heart disease.
- The Phase 1b study included patients with HFrEF and renal impairment.
Because both studies are completed, they are no longer open for enrollment.
What the trial designs mean for patients
These trials were designed to answer different questions at different stages of research. Phase 1b studies are usually early studies in a small group, while Phase 2b studies test effects in a larger group after earlier work.
The use of randomisation, double-blinding, and placebo control makes the results more reliable because it reduces bias, which is when expectations can affect the findings.
From the trial data, Azd3427 is being investigated in two specific settings: one linked to lung blood vessel pressure in left heart disease, and one linked to kidney blood flow in patients with reduced heart pumping function.