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

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.

Timeline

Start

2021-06-30

Primary completion

2024-03-27

Completion

2024-03-27

Outcome

Missed primary endpoint

registry analysis (superiority test); AZD4831 2.5 mg; p = 0.537; Mean Difference (Final Values) -0.92 (95% CI -3.86 to 2.02); ANCOVA; note: Two-sided test. NCT04986202 ↗

registry analysis (superiority test); AZD4831 5 mg vs Placebo; p = 0.195; Mean Difference (Final Values) 5.3 (95% CI -2.7 to 13.3); ANCOVA; note: Two-sided test. NCT04986202 ↗

Publications

• Lund LH, Lam CSP, Pizzato PE, Gabrielsen A, Michaelsson E, Nelander K, Ericsson H, Holden J, Folkvaljon F, Mattsson A, Collen A, Aurell M, Whatling C, Baldus S, Drelich G, Goudev A, Merkely B, Bergh N, Shah SJ. Rationale and design of ENDEAVOR: A sequential phase 2b-3 randomized clinical trial to evaluate the effect of myeloperoxidase inhibition on symptoms and exercise capacity in heart failure with preserved or mildly reduced ejection fraction. Eur J Heart Fail. 2023 Sep;25(9):1696-1707. doi: 10.1002/ejhf.2977. Epub 2023 Aug 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mitiperstat	Small molecule	2.5 mg	—
Subject	Mitiperstat	Small molecule	5 mg	—

Indications