LY3540378 for Chronic Heart Failure

Recruiting in Palo Alto (17 mi)

+167 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Eli Lilly and Company

Prior Safety Data

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.

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.

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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.

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Treatment Details

Interventions

LY3540378 (Not Applicable)
Placebo (Not Applicable)

Trial OverviewThe 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

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.