NCT04986202

Study to Evaluate the Efficacy and Safety of AZD4831 in Participants With Heart Failure With Left Ventricular Ejection Fraction > 40%

A Randomised, Double-blind, Placebo-controlled, Multi-center Sequential Phase 2b and Phase 3 Study to Evaluate the Efficacy and Safety of AZD4831 Administered for Up to 48 Weeks in Participants With Heart Failure With Left Ventricular Ejection Fraction > 40%

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 711 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a randomised, double-blind, placebo-controlled, multi-center sequential phase 2b and Phase 3 study to evaluate the efficacy and safety of AZD4831 administered for up to 48 Weeks in participants with heart failure with left ventricular ejection fraction \> 40%. The study will consist of 2 separate parts, Part A and Part B, approximately 660 participants will be randomised in Part A, 820 in Part B.

Conditions

• Heart Failure With Preserved Ejection Fraction

Interventions

Type	Name	Description
DRUG	AZD4831	AZD4831
OTHER	Placebo	Placebo

Timeline

• Start date: 2021-06-30
• Primary completion: 2024-03-27
• Completion: 2024-03-27
• First posted: 2021-08-02
• Last updated: 2025-08-27
• Results posted: 2025-08-27

Locations

171 sites across 18 countries: United States, Australia, Belgium, Brazil, Bulgaria, Canada, Czechia, Denmark, France, Hungary, Japan, Netherlands, Poland, Russia, Slovakia, Sweden, Taiwan, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study