NCT06639087

A Phase Ib Study of AZD5462 on Top of Dapagliflozin in Participants With Heart Failure and Moderate Renal Impairment

Phase Ib Randomised, Placebo-controlled, Double-blind, Multicentre Study to Assess the Effects and Safety of AZD5462 on Top of Dapagliflozin in Participants With Heart Failure and Moderate Renal Impairment

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

A study to investigate the effects and safety of AZD5462 on top of dapagliflozin in participants with heart failure and moderate renal impairment.

Detailed description

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)

Conditions

• Renal Impairment
• Heart Failure

Interventions

Type	Name	Description
DRUG	AZD5462	Participants will receive AZD5462 on top of dapagliflozin once daily.
DRUG	Dapagliflozin	Participants will receive dapagliflozin once daily with AZD5462 or placebo.
OTHER	Placebo	Participants will receive placebo on top of dapagliflozin once daily.

Timeline

• Start date: 2024-09-27
• Primary completion: 2025-05-29
• Completion: 2025-05-29
• First posted: 2024-10-15
• Last updated: 2025-09-24

Locations

1 site across 1 country: Bulgaria