A Study of LY3540378 in Participants With Worsening Chronic Heart Failure With Preserved Ejection Fraction (HFpEF)

Phase 2 Terminated 332 enrolled Eli Lilly and Company

RandomizedParallel-groupDouble-blindTreatment

Summary

The main purpose of this study is to assess the efficacy and safety of LY3540378 in adults with worsening heart failure with preserved ejection fraction

Timeline

Start: 2023-02-03
Primary completion: 2025-01-22
Completion: 2025-01-22

Outcome

Met primary endpoint

Stopped: “An interim was conducted and after review of available data, including efficacy evaluation of heart failure events, Lilly is terminating the study due to low likelihood of study success for this HFpEF patient population.”

paper Compared to placebo, 25-mg volenrelaxin improved LA reservoir strain (+3.9%, 95% confidence interval (CI): 1.1-6.6, P = 0.006) PMID 40887551 ↗

Publications

Borlaug BA, Testani JM, Petrie MC, Wang Z, Cunningham J, Adams KF Jr, Amir O, Belohlavek J, Bocchi E, Freitas A Jr, Hominal M, Kadokami T, Merkely B, Miller CA, Nunez J, Verma S, Yilmaz MB, Oru E, Sam F. Effects of volenrelaxin in worsening heart failure with preserved ejection fraction: a phase 2 randomized trial. Nat Med. 2025 Nov;31(11):3853-3861. doi: 10.1038/s41591-025-03939-6. Epub 2025 Aug 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Volenrelaxin	Protein / enzyme biologic	25 mg	Subcutaneous
Subject	Volenrelaxin	Protein / enzyme biologic	50 mg	Subcutaneous
Subject	Volenrelaxin	Protein / enzyme biologic	100 mg	Subcutaneous