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Not Applicable

LY3540378 for Chronic Heart Failure

Phase 2
Recruiting
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Prior chronic treatment, or prescription, with a loop diuretic (for example, furosemide, torsemide, bumetanide) for ≥30 days prior to the index event. Medical records, discharge notes and physician referral letters may serve as documentation for prior chronic treatment with a loop diuretic.
Documented LVEF of ≥50% within 12 months prior to screening; as measured by echocardiography, radionuclide ventriculography, invasive angiography, magnetic resonance imaging (MRI), or computerized tomograph (CT). Evidence of documentation of LVEF of ≥50% may also include participant medical records, discharge notes or a referral letter from the participant's physician or referring physician that details the participant's medical history.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 26
Awards & highlights

Study Summary

This trial aims to test a drug to treat worsening heart failure in adults with normal heart function.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects of LY3540378 are not listed here, common side effects in trials involving heart failure medications may include kidney problems, low blood pressure, changes in electrolyte levels, dizziness or fatigue. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been on a water pill for heart or kidney issues for at least 30 days.
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My heart's pumping ability is confirmed to be good.
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I was recently hospitalized for heart failure and needed strong water pills.
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I have symptoms of heart failure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 26
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 26 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in Left Atrial Reservoir Strain (LARS)
Secondary outcome measures
Change from Baseline Left Atrial End-Systolic Volume Index (LAESVI)
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
Change from Baseline in Left Atrial End-Diastolic Volume Index (LAEDVI)
+3 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: LY3540378 Dose 3Experimental Treatment1 Intervention
Participants will receive LY3540378 SC.
Group II: LY3540378 Dose 2Experimental Treatment1 Intervention
Participants will receive LY3540378 SC.
Group III: LY3540378 Dose 1Experimental Treatment1 Intervention
Participants will receive LY3540378 subcutaneously (SC).
Group IV: PlaceboPlacebo Group1 Intervention
Participants will be given placebo SC.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LY3540378
2021
Completed Phase 1
~140

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,618 Previous Clinical Trials
3,201,128 Total Patients Enrolled
13 Trials studying Heart Failure
19,974 Patients Enrolled for Heart Failure
Study DirectorEli Lilly and Company
1,347 Previous Clinical Trials
405,322 Total Patients Enrolled
2 Trials studying Heart Failure
750 Patients Enrolled for Heart Failure

Media Library

LY3540378 (Not Applicable) Clinical Trial Eligibility Overview. Trial Name: NCT05592275 — Phase 2
Heart Failure Research Study Groups: LY3540378 Dose 2, LY3540378 Dose 1, LY3540378 Dose 3, Placebo
Heart Failure Clinical Trial 2023: LY3540378 Highlights & Side Effects. Trial Name: NCT05592275 — Phase 2
LY3540378 (Not Applicable) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05592275 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many healthcare facilities are participating in this trial?

"Both North York Diagnostic and Cardiac Centre in North York, Ontario and Fadia El Boreky Medicine in Waterloo, California are participating sites for this research trial. The University of Texas Medical Branch located in Galveston, Pennsylvania is also enrolling patients along with 24 other medical facilities."

Answered by AI

Is this investigation actively seeking participants?

"As indicated on clinicaltrials.gov, the slated participants for this medical trial are not currently being recruited. Initially posted in November of 2022 and last updated two weeks prior, 701 other trials remain open to new patients at present."

Answered by AI

Has the Federal Drug Administration sanctioned LY3540378 Dose 1?

"Our experts at Power gave LY3540378 Dose 1 a rating of 2 on the safety scale, as Phase 2 trials have yet to yield data demonstrating efficacy."

Answered by AI

Who else is applying?

What site did they apply to?
Abington Memorial Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

Wanted to know more about the disease and getting help.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study of LY3540378 in Participants With Worsening Chronic Heart Failure With Preserved Ejection Fraction (HFpEF)
2023. "A Study of LY3540378 in Participants With Worsening Chronic Heart Failure With Preserved Ejection Fraction (HFpEF)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05592275.
~243 spots leftby Nov 2025
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