volenrelaxin (LY3540378) / Eli Lilly - LARVOL DELTA

Efficacy and Safety of Volenrelaxin in Adults With Chronic Kidney Disease (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Eli Lilly and Company | Terminated ➔ Withdrawn

Trial withdrawal • Chronic Kidney Disease • Nephrology • Renal Disease

Effects of volenrelaxin in worsening heart failure with preserved ejection fraction: a phase 2 randomized trial. (PubMed, Nat Med) - P2 | "In conclusion, despite some evidence for improvement in LA function at a low dose, treatment with this long-acting form of human relaxin was associated with worsening congestion in patients with recently decompensated HFpEF. ClinicalTrials.gov identifier: NCT05592275 ."

Journal • P2 data • Cardiovascular • Congestive Heart Failure • Heart Failure

RELAXIN-LA in worsening HFpEF (ESC-WCC 2025) - No abstract available

Late-breaking abstract • Cardiovascular • Congestive Heart Failure • Heart Failure

Long-acting relaxin analogues: a novel tool in cardiology. (PubMed, Front Pharmacol) - P1 | "In this article, we provide an overview of the mechanisms underlying the effects of long-acting relaxin analogues and their positive impact on the cardiovascular system. Additionally, we present a comprehensive comparison between serelaxin and its novel analogues, exploring their potential implications for the future treatment of cardiovascular diseases."

Journal • Review • Cardiovascular • Congestive Heart Failure • Heart Failure

AZD3427, a novel relaxin receptor agonist and impact on renal perfusion in patients with heart failure with reduced ejection rraction: the phase 1b Re-Perfuse study design (HEART FAILURE 2025) - "AZD3427, a long-acting relaxin analog and selective agonist of RXFP1, showed trends of increased stroke volume and estimated glomerular filtration rate (eGFR) in HF patients treated with AZD3427. Conclusion This study, alongside other ongoing AZD3427 studies, aims to evaluate the dual effects of AZD3427 in improving both cardiac and renal function. These insights could guide the development of future therapeutic strategies for managing HF and renal impairment."

Clinical • P1 data • Cardiovascular • Congestive Heart Failure • Heart Failure

A Study of LY3540378 in Participants With Worsening Chronic Heart Failure With Preserved Ejection Fraction (HFpEF) (clinicaltrials.gov) - P2 | N=335 | Terminated | Sponsor: Eli Lilly and Company | Active, not recruiting ➔ Terminated; 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.

Trial termination • Cardiovascular • Congestive Heart Failure • Heart Failure

UPDATED: Eli Lilly lops...assets from pipeline in Q4 update (FierceBiotech) - "The drugmaker also removed ucenprubart and volenrelaxin from its pipeline. Ucenprubart is a CD200R1 agonist that Lilly was studying as a treatment for eczema. Lilly stopped enrollment in a phase 2 trial of the candidate, which is also known as LY3454738, last month before reaching its recruitment target....Volenrelaxin was in development in heart failure and chronic kidney disease (CKD)."

Discontinued • Enrollment closed • Atopic Dermatitis • Chronic Kidney Disease • Dermatology • Heart Failure

Efficacy and Safety of Volenrelaxin in Adults With Chronic Kidney Disease (clinicaltrials.gov) - P2 | N=8 | Terminated | Sponsor: Eli Lilly and Company | N=280 ➔ 8 | Trial completion date: Apr 2026 ➔ Dec 2024 | Recruiting ➔ Terminated | Trial primary completion date: Feb 2026 ➔ Dec 2024; Study was terminated due to a lack of foreseeable clinical benefit in the proposed chronic kidney disease population, following the termination of a related heart failure study that demonstrated no benefit in an overlapping patient group.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Chronic Kidney Disease • Nephrology • Renal Disease

A Study of LY3540378 in Participants With Worsening Chronic Heart Failure With Preserved Ejection Fraction (HFpEF) (clinicaltrials.gov) - P2 | N=456 | Active, not recruiting | Sponsor: Eli Lilly and Company | Recruiting ➔ Active, not recruiting | Trial completion date: Jan 2026 ➔ Jan 2025 | Trial primary completion date: Nov 2025 ➔ Jan 2025

Enrollment closed • Trial completion date • Trial primary completion date • Cardiovascular • Congestive Heart Failure • Heart Failure

Efficacy and Safety of Volenrelaxin in Adults With Chronic Kidney Disease (clinicaltrials.gov) - P2 | N=280 | Recruiting | Sponsor: Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Kidney Disease • Nephrology • Renal Disease

Efficacy and Safety of Volenrelaxin in Adults With Chronic Kidney Disease (clinicaltrials.gov) - P2 | N=280 | Not yet recruiting | Sponsor: Eli Lilly and Company

New P2 trial • Chronic Kidney Disease • Nephrology • Renal Disease

Volenrelaxin (LY3540378) increases Renal Plasma Flow: A Randomized Phase 1 Trial. (PubMed, Nephrol Dial Transplant) - P1 | "Volenrelaxin was well-tolerated, safe and suitable for weekly SC dosing. Volenrelaxin showed a sustained improvement in kidney perfusion upon repeated dosing, supporting further clinical development in chronic kidney disease and chronic heart failure. Clinical trial registration: NCT04768855."

Clinical • Journal • P1 data • Cardiovascular • Chronic Kidney Disease • Congestive Heart Failure • Heart Failure • Hypotension • Nephrology • Renal Disease

A Study of LY3540378 in Participants With Worsening Chronic Heart Failure With Preserved Ejection Fraction (HFpEF) (clinicaltrials.gov) - P2 | N=432 | Recruiting | Sponsor: Eli Lilly and Company | Trial completion date: Jan 2025 ➔ Jan 2026 | Trial primary completion date: Nov 2024 ➔ Nov 2025

Trial completion date • Trial primary completion date • Cardiovascular • Congestive Heart Failure • Heart Failure

Long-acting relaxin (LY3540378) demonstrates improved renal hemodynamics response in preclinical and clinical studies (HEART FAILURE 2023) - "This clinical trial involving healthy participants demonstrated an increase in RBF, confirming the pharmacology of LY3540378 as long-acting relaxin. This beneficial physiological profile supports the need for future clinical investigation of LY3540378 in patients with chronic HF and/or CKD."

Preclinical • Cardiovascular • Congestive Heart Failure • Heart Failure

A Study of LY3540378 in Participants With Worsening Chronic Heart Failure With Preserved Ejection Fraction (HFpEF) (clinicaltrials.gov) - P2 | N=432 | Recruiting | Sponsor: Eli Lilly and Company | Trial completion date: Aug 2024 ➔ Jan 2025 | Trial primary completion date: Jul 2024 ➔ Nov 2024

Trial completion date • Trial primary completion date • Cardiovascular • Congestive Heart Failure • Heart Failure

Development of a Long-Acting Relaxin Analog, LY3540378, for Treatment of Chronic Heart Failure. (PubMed, Br J Pharmacol) - "LY3540378 demonstrated to be a suitable clinical development candidate and is progressing in clinical trials."

Journal • Cardiovascular • Congestive Heart Failure • Heart Failure

A Study of LY3540378 in Participants With Worsening Chronic Heart Failure With Preserved Ejection Fraction (HFpEF) (clinicaltrials.gov) - P2 | N=432 | Recruiting | Sponsor: Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Congestive Heart Failure • Heart Failure

A Study of LY3540378 in Participants With Worsening Chronic Heart Failure With Preserved Ejection Fraction (HFpEF) (clinicaltrials.gov) - P2 | N=432 | Not yet recruiting | Sponsor: Eli Lilly and Company

New P2 trial • Cardiovascular • Congestive Heart Failure • Heart Failure

A Study of LY3540378 in Healthy Participants (clinicaltrials.gov) - P1 | N=134 | Completed | Sponsor: Eli Lilly and Company | Active, not recruiting ➔ Completed

Trial completion