NCT06299826

A Phase IIb Study of AZD5462 in Patients With Chronic Heart Failure

A Phase IIb Two-Cohort, Randomised, Placebo-controlled, Double-blind, Multi-centre, Dose-ranging Study of AZD5462 in Stable Patients With Chronic Heart Failure

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 375 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to evaluate the effect of AZD5462 on cardiac function in participants with chronic heart failure (HF).

Detailed description

This is a Phase IIb randomized, double-blind, placebo-controlled, multi-center, dose-ranging study to evaluate the efficacy, safety, and pharmacokinetic (PK) of AZD5462 on top of standard of care in 2 cohorts of participants with HF: Cohort A, and Cohort B. The study will include 3 periods and approximately 12 study visits: * Screening period of up to 4 weeks (at least 1 study visit) * Treatment period of 24 weeks (8 study visits) * Follow-up period of 4 weeks (3 study visits) Eligible participants in each cohort will be randomized equally 1:1:1:1 to receive a once daily dose (OD) of 3 dose levels (low, medium, or high) oral dose of AZD5462 tablets or placebo.

Conditions

• Chronic Heart Failure

Interventions

Type	Name	Description
DRUG	AZD5462	Participants will receive low, medium \& high doses of film-coated tablets of AZD5462 OD orally.
DRUG	Placebo	Participants will receive matching doses of film-coated tablets of Placebo OD orally.

Timeline

• Start date: 2024-06-04
• Primary completion: 2026-02-10
• Completion: 2026-02-10
• First posted: 2024-03-08
• Last updated: 2026-02-18

Locations

56 sites across 10 countries: United States, Bulgaria, Czechia, Denmark, Hungary, India, Japan, Netherlands, Poland, Slovakia

Regulatory

• FDA-regulated drug study