Safety and Tolerability Study of AZD4831 in Patients With Heart Failure.

Phase 2 Terminated 41 enrolled AstraZeneca

RandomizedParallel-groupTriple-blindTreatment

Summary

A randomized, double-blind, placebo-controlled, parallel group, multicentre study in patients with Heart Failure with preserved Ejection Fraction (HFpEF). The study will be conducted at approximately 15 sites in 5 countries. Approximately 96 patients will be randomized to AZD4831 or placebo (treatment duration 90 days).

Timeline

Start: 2018-12-11
Primary completion: 2020-05-07
Completion: 2020-05-07

Outcome

Met primary endpoint

Stopped: “A decision was made to stop the study early when AstraZeneca evaluated the available data and it was considered that completing the study would provide limited additional information and unlikely to change the study conclusions.”

registry analysis (superiority test); AZD4831 vs Placebo; p <0.001; Least Square Means Ratio 0.25 (95% CI 0.12 to 0.52); Mixed Models Analysis NCT03756285 ↗

paper with a placebo-adjusted decreased of 75% (95% confidence interval, 48, 88, nominal P < .001). PMID 37072105 ↗

Publications

Lam CSP, Lund LH, Shah SJ, Voors AA, Erlinge D, Saraste A, Pirazzi C, Grove EL, Barasa A, Schou M, Aziz A, Svedlund S, Wijngaarden JV, Lindstedt EL, Gustavsson A, Nelander K, Garkaviy P, Gan LM, Gabrielsen A. Myeloperoxidase Inhibition in Heart Failure With Preserved or Mildly Reduced Ejection Fraction: SATELLITE Trial Results. J Card Fail. 2024 Jan;30(1):104-110. doi: 10.1016/j.cardfail.2023.04.003. Epub 2023 Apr 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mitiperstat	Small molecule	5 mg	Oral