Table of contents
- Clinical trial overview
- Phase 2b study in pulmonary hypertension
- Phase 1b study in renal perfusion
- What the trials measured
- Who could participate
- What the trial designs mean for patients
Clinical trial overview
Azd3427 has been studied in two interventional trials, both of which are completed.[1][2] These trials focused on people with heart failure and related problems in blood flow to the lungs or kidneys.[1][2]
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.[1] The other was a Phase 1b, double-blind, placebo-controlled, randomised trial in patients with heart failure with reduced ejection fraction and renal impairment.[2]
Phase 2b study in pulmonary hypertension
The Phase 2b study, NCT05737940, enrolled 234 participants and was completed.[1] It studied people with heart failure and pulmonary hypertension due to left heart disease, also called WHO Group 2 pulmonary hypertension.[1]
This trial compared Azd3427 with placebo, which is a treatment with no active study drug.[1] 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.[1]
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.[1] 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.[1]
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.[1]
Phase 1b study in renal perfusion
The Phase 1b study, 2024-513143-82-00, enrolled 12 participants and was completed.[2] It studied patients with heart failure with reduced ejection fraction (HFrEF) and renal impairment, meaning reduced kidney function.[2]
This trial was also randomised, double-blind, and placebo-controlled.[2] 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.[2]
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.[2] This was measured from baseline to Day 8 and compared with placebo using quantitative parametric mapping on PET.[2]
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.[2]
What the trials measured
In the Phase 2b study, the key endpoint was change in PVR from baseline to Week 25 compared with placebo.[1] This endpoint matters because lower PVR can suggest easier blood flow through the lungs.[1]
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.[2] This endpoint matters because better kidney perfusion can show that more blood is reaching the kidney tissue being studied.[2]
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.[1][2]
Who could participate
The studies focused on different patient groups, but both involved people with heart failure and related organ blood flow problems.[1][2]
The Phase 2b study included participants with heart failure and pulmonary hypertension due to left heart disease.[1]
The Phase 1b study included patients with HFrEF and renal impairment.[2]
Because both studies are completed, they are no longer open for enrollment.[1][2]
What the trial designs mean for patients
These trials were designed to answer different questions at different stages of research.[1][2] Phase 1b studies are usually early studies in a small group, while Phase 2b studies test effects in a larger group after earlier work.[1][2]
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.[1][2]
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.[1][2]
