Efficacy and Safety of Relaxin-LA (LY3540378) in Adults with Worsening Chronic HFpEF
Research type
Research Study
Full title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of LY3540378 in Adults with Worsening Chronic Heart Failure with Preserved Ejection Fraction (HFpEF)
IRAS ID
1006231
Contact name
Sidra Ali
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2022-000780-48
Clinicaltrials.gov Identifier
Research summary
There are currently millions of adults who suffer from heart failure. Among those patients, at least 50% present clinically with HFpEF but this number is increasing.
Heart Failure with Preserved Ejection Fraction (HFpEF) is a type of heart failure that occurs when the muscle in the heart chambers stiffens, so the pressure inside the heart rises. To date there have been very little clinical trials that show benefit of an experimental therapy in HFpEF. Study J3E-MC-EZDB (EZDB) will investigate the effects of the study medication Relaxin-LA (LY3540378), on worsening chronic HFpEF.
Relaxin-LA is an injectable molecule. This study will test different doses of Relaxin-LA, when compared to placebo (placebo looks like the study medication but has no medicine (no therapeutic effect)).
This study is taking place internationally and there will be about 432 other patients all around the world who will be taking part including approximately 20 patients from the UK. Participation in this study will last 32 weeks.REC name
West of Scotland REC 1
REC reference
22/WS/0157
Date of REC Opinion
14 Feb 2023
REC opinion
Further Information Favourable Opinion