A Phase Ib Study of AZD5462 on Top of Dapagliflozin in Participants With Heart Failure and Modera… (NCT06639087) | Clinical Trial Compass
TerminatedPhase 1
A Phase Ib Study of AZD5462 on Top of Dapagliflozin in Participants With Heart Failure and Moderate Renal Impairment
Stopped: Sponsor Decision
Bulgaria8 participantsStarted 2024-09-27
Plain-language summary
A study to investigate the effects and safety of AZD5462 on top of dapagliflozin in participants with heart failure and moderate renal impairment.
Who can participate
Age range18 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 h…