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A Study of LY3540378 in Participants With Worsening Chronic Heart Failure With Preserved Ejection Fraction (HFpEF) | Clinical Trials | Clareo Health

TERMINATEDPHASE2

A Study of LY3540378 in Participants With Worsening Chronic Heart Failure With Preserved Ejection Fraction (HFpEF)

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)

NCT05592275•Eli Lilly and Company

View on ClinicalTrials.gov

Summary

The main purpose of this study is to assess the efficacy and safety of LY3540378 in adults with worsening heart failure with preserved ejection fraction

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Experienced an index event, defined as a recent hospitalization for HF requiring ≥1 bolus doses of intravenous diuretics or an out- of- hospital encounter (for example, Emergency Room, clinic visit, infusion clinic, etc.) for HF requiring ≥1 bolus doses of intravenous diuretics.
•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.
•Had evidence of clinical HF syndrome consisting of hospitalization for worsening heart failure (WHF) with intravascular volume overload (the index event), as determined by the investigator, based on appropriate supportive documentation at randomization, and defined by ≥2 of the following:
•* dyspnea
•* jugular venous distention
•* pitting edema in lower extremities (\>1+)
•* ascites
•* pulmonary congestion on chest X-ray
•* pulmonary rales AND participant received treatment with IV diuretics.
+9 more criteria

Exclusion Criteria

•Prior documentation of low ventricle ejection fraction (LVEF) ≤45% in the past 12 months.
•Have had acute coronary syndrome or percutaneous coronary intervention, coronary artery bypass graft, cardiac mechanical support implantation, within 3 months prior to V2. (randomization), - or any other cardiac surgery planned during the study.
•Have had left ventricular assist device (LVAD) or cardiac transplantation or have cardiac transplantation planned during the study.
•Have hypertrophic cardiomyopathy (obstructive or nonobstructive), restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac sarcoidosis, known amyloid cardiomyopathy, or inherited cardiomyopathy.
•Have a chronic pulmonary/lung disease (COPD), (pulmonary arterial hypertension, etc) as defined by chronic oxygen dependence. Night-time oxygen is not exclusionary.
•Uncorrected thyroid disease.

Locations (137)

Pima Heart

Tucson, Arizona, United States

Valley Clinical Trials, Inc.

Covina, California, United States

Valley Clinical Trials, Inc.

Northridge, California, United States

University of California Irvine Medical Center

Orange, California, United States

Pasadena Clinical Research

Pasadena, California, United States

Velocity Clinical Research, Coastal Heart Medical Group

Santa Ana, California, United States

Excel Medical Clinical Trials

Boca Raton, Florida, United States

Infinite Clinical Research

Miami, Florida, United States

South Florida Research Solutions - North Flamingo Road

Pembroke Pines, Florida, United States

University Medical Center New Orleans

New Orleans, Louisiana, United States

Key Dates

Start Date

February 3, 2023

Primary Completion Date

January 22, 2025

Completion Date

January 22, 2025

Last Updated

February 5, 2026

Enrollment

332

ACTUAL participants

Conditions

Heart FailureHeart Failure With Preserved Ejection Fraction

Interventions

LY3540378

DRUG

Placebo

DRUG

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 5, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of LY3540378 in Participants With Worsening Chronic Heart Failure With Preserved Ejection Fraction (HFpEF)

Inclusion Criteria

Exclusion Criteria

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