New Heart-Kidney combo drug tested in tiny study
NCT ID NCT06639087
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early study tested a new drug called AZD5462 added to the standard medicine dapagliflozin in people with heart failure and moderate kidney disease. Only 8 participants were enrolled before the study was stopped. The goal was to see if the combination is safe and affects how the body handles salt and kidney function.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AZD5462
- What this could lead to
- If it works, this could point toward a new combination treatment to help people with both heart failure and kidney disease.
- What could go wrong
- This is a very early, tiny study (only 8 people) that was terminated, so results are limited. It may not lead to any new treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
8 people
The number who actually took part.
- Started
-
Sep 2024
- Finished
-
May 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 85 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participants must have a pre-existing diagnosis of heart failure (HF). * Participants must have a left ventricular ejection fraction (LVEF) of ≤ 40% based on echocardiography taken within the last 9 months. * Participants must have an estimated glomerular filtration rate (eGFR) of 30 to 60 milliliters per minute per 1.73 meters squared (mL/min/1.73 m2) (inclusive) at Screening as assessed by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) 2021 (creatinine) equation. * Participants must be on stable HF standard of care (SoC) medication for at least 4 weeks prior to Screening. If the participant is currently taking diuretics, then diuretics must also be stable for at least one week prior to Screening. * Participants must be on stable Sodium-glucose co-transporter-2 inhibitors (SGLT2) inhibitor treatment for at least 12 weeks prior to Screening. * Minimum BMI of 18 kilograms per meter squared (kg/m2) at Screening. Exclusion Criteria: * Historical or current evidence of a clinically significant disease or disorder. * Participants with a known hypersensitivity to AZD5462 or dapagliflozin, or to any of the excipients of these drug products. * 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. However, participants with atrial fibrillation or flutter and controlled ventricular rate (eg, resting heart rate \< 110 beats per minute) are permitted. Participants with cardiac ventricular arrhythmia that are treated with antiarrhythmic agents (eg, amiodarone) and are stable are permitted. * History of or anticipated heart transplant. * Any planned highly invasive cardiovascular procedure (eg, coronary revascularisation, valve repair/replacement, aortic aneurysm surgery). * Any evidence of clinically important disease or disorder which in the Investigator's opinion makes it undesirable for the participant to participate in the study. * Positive hepatitis C antibody, hepatitis B virus surface antigen, or hepatitis B virus core antibody at Screening.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Research Site
Sofia, 1612, Bulgaria
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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