A Study of LY3540378 in Participants With Worsening Chronic Heart Failure With Preserved Ejection Fraction (HFpEF)
NCT ID: NCT05592275
Last Updated: 2025-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
335 participants
INTERVENTIONAL
2023-02-03
2025-01-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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LY3540378 Dose 1
Participants will receive LY3540378 subcutaneously (SC).
LY3540378
Administered SC
LY3540378 Dose 2
Participants will receive LY3540378 SC.
LY3540378
Administered SC
LY3540378 Dose 3
Participants will receive LY3540378 SC.
LY3540378
Administered SC
Placebo
Participants will be given placebo SC.
Placebo
Administered SC
Interventions
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LY3540378
Administered SC
Placebo
Administered SC
Eligibility Criteria
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Inclusion Criteria
* 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.
OR
* Treatment for an urgent visit outside of of being hospitalized with WHF and intravascular volume overload (the index visit) requiring treatment with IV diuretics (defined as ≥2 IV doses) such as in the outpatient setting/emergency room/observation unit/infusion clinic with a clinical response within the past 2 weeks prior to randomization. Urgent visit is defined as an unplanned visit for HF defined by ≥2 of the following:
* dyspnea
* jugular venous distention
* pitting edema in lower extremities (\>1+)
* ascites
* pulmonary rales on lung examination.
* NT-proBNP (\>300 \[sinus rhythm\] or 600 pg/mL \[atrial fibrillation or atrial flutter\] OR BNP (\>100 \[sinus rhythm\] or 200 pg/mL \[atrial fibrillation or atrial flutter\]) at screening.
* eGFR of \>20 mL/min/1.73 m² at V1 (screening; determined by local laboratory), derived from serum creatinine values, age, and sex based on the CKD-EPI equation.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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
Boston Medical Center
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota, United States
University of North Carolina Medical Center
Chapel Hill, North Carolina, United States
Abington Memorial Hospital
Abington, Pennsylvania, United States
PharmaTex Research
Amarillo, Texas, United States
Baylor Scott & White Health-Advanced Heart and Lung Disease
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
West Houston Area Clinical Trial Consultants
Houston, Texas, United States
Texas Institute of Cardiology, PA
McKinney, Texas, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Centro de Investigaciones Metabólicas (CINME)
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Zarate
Zárate, Buenos Aires, Argentina
Investigaciones Medicas Imoba Srl
Balvanera, Buenos Aires F.D., Argentina
Sanatorio Anchorena Recoleta
Buenos Aires, Buenos Aires F.D., Argentina
Mautalen Salud e Investigación
Buenos Aires, Buenos Aires F.D., Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires, Buenos Aires F.D., Argentina
Instituto Médico Río Cuarto
Río Cuarto, Córdoba Province, Argentina
Hospital Provincial del Centenario
Rosario, Santa Fe Province, Argentina
Instituto de Investigaciones Clinicas Rosario
Rosario, Santa Fe Province, Argentina
Sanatorio San Martin
Venado Tuerto, Santa Fe Province, Argentina
Investigaciones Clínicas Tucumán
San Miguel de Tucumán, Tucumán Province, Argentina
CEMEDIC
Buenos Aires, , Argentina
Fundación Respirar
Buenos Aires, , Argentina
Centro de Investigaciones Clinicas del Litoral
Santa Fe, , Argentina
Clínica de Nefrología, Urología y Enfermedades Cardiovasculares
Santa Fe, , Argentina
Centro de Pesquisa Silvestre Santé
Rio Branco, Acre, Brazil
Universidade Federal de Goias
Goiânia, Goiás, Brazil
PUC Trials- Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR
Curitiba, Paraná, Brazil
Centro de Pesquisa Clinica do Coracao
Acaraju, Sergipe, Brazil
Centro de Pesquisa Sao Lucas
Campinas, São Paulo, Brazil
Instituto de Pesquisa clinica de Campinas
Campinas, São Paulo, Brazil
Instituto Do Coracao De Marilia
Marília, São Paulo, Brazil
CAPED Centro Avancado Pesquisa e Diagnostica
Ribeirão Preto, São Paulo, Brazil
Pesquisare Saude
Santo André, São Paulo, Brazil
Hospital Santa Paula
São Paulo, São Paulo, Brazil
Incor - Instituto do Coracao
São Paulo, São Paulo, Brazil
Instituto de Molestias Cardiovasculares de Tatui
Tatuí, São Paulo, Brazil
Integral Pesquisa e Ensino
Votuporanga, São Paulo, Brazil
Hospital São Lucas de Copacabana
Rio de Janeiro, , Brazil
Instituto D'Or Pesquisa e Ensino
Rio de Janeiro, , Brazil
SMH Cardiology Clinical Trials
Surrey, British Columbia, Canada
Private Practice - Dr. Saul Vizel
Cambridge, Ontario, Canada
PACE Cardiology
Newmarket, Ontario, Canada
North York Diagnostic and Cardiac Centre
North York, Ontario, Canada
Oakville Trafalgar Memorial Hospital
Oakville, Ontario, Canada
Heart Health Institute - Scarborough Office
Scarborough Village, Ontario, Canada
Medicus MFC Research Clinic
Toronto, Ontario, Canada
CPS Research
Waterloo, Ontario, Canada
Centre Hospitalier Universite de Sherbrooke - Hôtel-Dieu Hospital
Sherbrooke, Quebec, Canada
Fakultní nemocnice Brno Bohunice
Brno, Brno-město, Czechia
Fakultni Nemocnice u sv. Anny v Brne
Brno, South Moravian, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Szeged, Csongrád megye, Hungary
Medifarma 98 Kft
Nyíregyháza, Nyíregyháza, Hungary
Kistarcsai Flor Ferenc Korhaz
Kistarcsa, Pest County, Hungary
Belvárosi Egészségház
Zalaegerszeg, Zala County, Hungary
Dél-Pesti Centrumkórház
Budapest, , Hungary
Semmelweis University
Budapest, , Hungary
Yitzhak Shamir Medical Center
Ẕerifin, Central District, Israel
Hadassah Medical Center
Jerusalem, Jerusalem, Israel
Rambam Health Care Campus
Haifa, Northern District, Israel
Sourasky Medical Center
Tel Aviv, Tell Abīb, Israel
Kasugai Municipal Hospital
Kasugai, Aichi-ken, Japan
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Nagoya, Aichi-ken, Japan
Saiseikai Futsukaichi Hospital
Chikushino-shi, Fukuoka, Japan
Nakamura Cardiovascular Clinic
Itoshima, Fukuoka, Japan
Gunma University Hospital
Maebashi, Gunma, Japan
National Hospital Organization Takasaki General Medical Centar
Takasaki, Gunma, Japan
Yokohama City University Medical Center
Yokohama, Kanagawa, Japan
Yokohama Minami Kyosai Hospital
Yokohama, Kanagawa, Japan
Kanagawa Cardiovascular and Respiratory Center
Yokohama, Kanagawa, Japan
Minamino Cardiovascular Hospital
Hachiōji, Tokyo, Japan
Ome Medical Center
Ōme, Tokyo, Japan
Yamanashi Prefectural Central Hospital
Kofu, Yamanashi, Japan
Harasanshin Hospital
Fukuoka, , Japan
Rakuwakai Otowa Hospital
Kyoto, , Japan
National Hospital Organization Okayama Medical Center
Okayama, , Japan
Sakurabashi Watanabe Advanced Healthcare Hospital
Osaka, , Japan
Yodogawa Christian Hospital
Osaka, , Japan
National Hospital Organization - Osaka National Hospital - Institute For Clinical Research
Osaka, , Japan
Toyama Prefectural Central Hospital
Toyama, , Japan
NZOZ Centrum Medyczne KERmed
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
INTERCOR
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Private Practice - Dr. Ewa Mirek Bryniarska
Krakow, Lesser Poland Voivodeship, Poland
MEDICOME Centrum Badań Klinicznych Oświęcimskie
Oświęcim, Lesser Poland Voivodeship, Poland
1 Wojskowy Szpital Kliniczny w Lublinie
Lublin, Lublin Voivodeship, Poland
CenterMed Lublin NZOZ
Lublin, Lublin Voivodeship, Poland
Balsam Medica
Warsaw, Masovian Voivodeship, Poland
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu
Przemyśl, Podkarpackie Voivodeship, Poland
Uniwersytecki Szpital Kliniczny w Białymstoku
Bialystok, Podlaskie Voivodeship, Poland
KLIMED Marek Klimkiewicz
Bialystok, Podlaskie Voivodeship, Poland
SPZOZ Uniwersytecki Szpital Kliniczny Im. Wojskowej Akademii Medycznej UM W Łodzi Centralny Szpital Wetera -T
Lodz, Łódź Voivodeship, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
Lodz, Łódź Voivodeship, Poland
IRMED Osrodek Badan Klinicznych
Piotrkow Trybunalski, Łódź Voivodeship, Poland
Provita Profamilia
Piotrkow Trybunalski, Łódź Voivodeship, Poland
CHUS - Hospital Clinico Universitario
Santiago de Compostela, A Coruña [La Coruña], Spain
Hospital de Denia Marina Salud
Denia, Alicante, Spain
Hospital Universitario Reina Sofia
Córdoba, Andalusia, Spain
Hospital Universitario Virgen de Valme
Seville, Andalusia, Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona [Barcelona], Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Catalunya [Cataluña], Spain
Hospital San Juan de la Cruz
Úbeda, Jaén, Spain
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Comunidad de, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, Murcia, Región de, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Málaga, Spain
Hospital Clinico de Valencia
Valencia, Valenciana, Comunitat, Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi
Yıldırım, Bursa, Turkey (Türkiye)
Eskisehir Osmangazi University
Eskişehir, Eskişehir, Turkey (Türkiye)
Ege Universitesi Hastanesi
Bornova, İzmir, Turkey (Türkiye)
Kocaeli Üniversitesi
İzmit, Kocaeli, Turkey (Türkiye)
Afyon Kocatepe Üniversitesi Tıp Fakültesi
Afyonkarahisar, , Turkey (Türkiye)
Ankara Etlik City Hospital
Ankara, , Turkey (Türkiye)
Trakya University Medical Faculty Hospital
Edirne, , Turkey (Türkiye)
T.C. Sağlık Bakanlığı İzmir Tepecik Eğitim ve Araştırma Hast
Izmir, , Turkey (Türkiye)
Dokuz Eylul Universitesi Hastanesi
Izmir, , Turkey (Türkiye)
Mersin University
Mersin, , Turkey (Türkiye)
Wycombe General Hospital
High Wycombe, Buckinghamshire, United Kingdom
Raigmore Hospital
Inverness, Highland, United Kingdom
Northwick Park Hospital
Harrow, London, City of, United Kingdom
Glasgow Royal Infirmary
Glasgow, Scotland, United Kingdom
West Middlesex University Hospital
Isleworth, , United Kingdom
Aintree University Hospital NHS Foundation Trust
Liverpool, , United Kingdom
Wythenshawe Hospital
Manchester, , United Kingdom
Royal Berkshire Hospital
Reading, , United Kingdom
Countries
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References
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Borlaug BA, Testani JM, Petrie MC, Wang Z, Cunningham J, Adams KF Jr, Amir O, Belohlavek J, Bocchi E, Freitas A Jr, Hominal M, Kadokami T, Merkely B, Miller CA, Nunez J, Verma S, Yilmaz MB, Oru E, Sam F. Effects of volenrelaxin in worsening heart failure with preserved ejection fraction: a phase 2 randomized trial. Nat Med. 2025 Aug 31. doi: 10.1038/s41591-025-03939-6. Online ahead of print.
Related Links
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A Study of LY3540378 in Participants With Worsening Chronic Heart Failure With Preserved Ejection Fraction (HFpEF)
Other Identifiers
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J3E-MC-EZDB
Identifier Type: OTHER
Identifier Source: secondary_id
2023-505902-40-00
Identifier Type: OTHER
Identifier Source: secondary_id
18473
Identifier Type: -
Identifier Source: org_study_id
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