LY3540378 for Chronic Heart Failure

Recruiting at 167 trial locations

Overseen By Seth J. Baum

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Eli Lilly and Company

Disqualifiers: Low LVEF, Recent cardiac surgery, Cardiomyopathy, Chronic lung disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 26 weeks

335 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called LY3540378 to see if it can help adults whose heart failure is getting worse even though their heart pumps normally. The goal is to find out if this medication can improve their heart function and safety.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How is the drug LY3540378 different from other treatments for chronic heart failure?

LY3540378 may offer a new approach by potentially improving heart function directly, unlike current treatments that mainly manage symptoms or reduce stress on the heart. This could be significant as no positive inotropes (drugs that increase heart muscle contraction) are currently approved for long-term use in heart failure. ^{1 2 3 4 5}

Research Team

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

This trial is for adults with chronic heart failure who've had a recent worsening event requiring intravenous diuretics. They must have had a preserved ejection fraction (≥50%) documented within the last year and been on loop diuretics for at least 30 days prior to their worsening event. Exclusions include recent acute coronary events, uncorrected thyroid disease, certain cardiomyopathies, severe lung diseases like COPD, or planned heart surgeries.

Inclusion Criteria

I was hospitalized or had an urgent visit for heart failure and treated with IV diuretics recently.

I have been on a water pill for heart or kidney issues for at least 30 days.

My heart's pumping ability is confirmed to be good.

Exclusion Criteria

I have or will have a heart assist device or heart transplant.

I have a diagnosed heart muscle condition.

I've had recent major heart surgery or plan to have one during the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LY3540378 or placebo subcutaneously

26 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• LY3540378
• Placebo

Trial Overview The study tests LY3540378's effectiveness and safety against a placebo in improving conditions for those with worsening chronic heart failure but preserved ejection fraction. Participants will be randomly assigned to receive either the investigational drug or an inactive substance without knowing which one they're getting.

Participant Groups

Group I: LY3540378 Dose 3 Experimental Treatment 1 Intervention

Participants will receive LY3540378 SC.

Group II: LY3540378 Dose 2 Experimental Treatment 1 Intervention

Participants will receive LY3540378 SC.

Group III: LY3540378 Dose 1 Experimental Treatment 1 Intervention

Participants will receive LY3540378 subcutaneously (SC).

Group IV: Placebo Placebo Group 1 Intervention

Participants will be given placebo SC.

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Findings from Research

Over the past 30 years, heart failure management has significantly improved, particularly for patients with heart failure and reduced ejection fraction (HFrEF), leading to better quality of life and outcomes.

Ongoing trials are exploring both established and new pharmacological treatments that could enhance therapy for HFrEF and potentially benefit patients with heart failure with preserved ejection fraction (HFpEF) and other heart failure types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New perspectives and future directions in the treatment of heart failure. Pellicori, P., Khan, MJI., Graham, FJ., et al.[2021]

In a study of 5050 patients with heart failure, vericiguat did not significantly improve health status outcomes measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) compared to placebo, indicating it may not enhance quality of life despite its use.

However, vericiguat effectively reduced the risk of cardiovascular death or heart failure hospitalization across different baseline health statuses, suggesting it is beneficial for clinical outcomes in heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vericiguat and Health-Related Quality of Life in Patients With Heart Failure With Reduced Ejection Fraction: Insights From the VICTORIA Trial. Butler, J., Stebbins, A., Melenovský, V., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Why has positive inotropy failed in chronic heart failure? Lessons from prior inotrope trials. [2020]

2. England pubmed.ncbi.nlm.nih.gov

A putative placebo analysis of the effects of LCZ696 on clinical outcomes in heart failure. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Adverse effects of enalapril in the Studies of Left Ventricular Dysfunction (SOLVD). SOLVD Investigators. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

New perspectives and future directions in the treatment of heart failure. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Vericiguat and Health-Related Quality of Life in Patients With Heart Failure With Reduced Ejection Fraction: Insights From the VICTORIA Trial. [2022]