A study to investigate the effects and safety of AZD5462 on top of dapagliflozin in participants with heart failure and moderate renal impairment.
This is a randomized, double-blind, placebo-controlled Phase 1b study to evaluate the safety, pharmacodynamics, and pharmacokinetics of AZD5462 on top of dapagliflozin in participants with heart failure and renal impairment. The study will include 5 periods and approximately 9 study site visits: * Screening Period of up to 4 weeks (at least one study visit) * Run-in Period of up to 4 weeks (one study visit) * Inpatient Treatment Period of 4 days (one study visit) * Outpatient Treatment Period of up to 4 weeks (three study visits) * Follow-up Period of up to 4 weeks (three study visits)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
8
Participants will receive AZD5462 on top of dapagliflozin once daily.
Participants will receive dapagliflozin once daily with AZD5462 or placebo.
Participants will receive placebo on top of dapagliflozin once daily.
Research Site
Sofia, Bulgaria
Change in sodium excretion
To evaluate the effect of AZD5462 on top of dapagliflozin in participants with heart failure (HF) and renal impairment.
Time frame: From Baseline to Day 1
Change in urine albumin-creatinine ratio (uACR)
To evaluate the effect of AZD5462 on top of dapagliflozin in participants with HF and renal impairment.
Time frame: From Baseline to Day 1 and 29
Change in haematocrit
To evaluate the effect of AZD5462 on top of dapagliflozin in participants with HF and renal impairment.
Time frame: From Baseline to Day 29
Number of adverse events (AEs) and Serious Adverse Events (SAEs)
To evaluate the effect of AZD5462 on top of dapagliflozin in participants with HF and renal impairment.
Time frame: From Baseline to Day 57
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