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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05592275
Collaborator
(none)
432
Enrollment
90
Locations
4
Arms
21.5
Anticipated Duration (Months)
4.8
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
432 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
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)
Anticipated Study Start Date :
Nov 22, 2022
Anticipated Primary Completion Date :
Jul 10, 2024
Anticipated Study Completion Date :
Sep 6, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY3540378 Dose 1

Participants will receive LY3540378 subcutaneously (SC).

Drug: LY3540378
Administered SC
Experimental: LY3540378 Dose 2

Participants will receive LY3540378 SC.

Drug: LY3540378
Administered SC
Experimental: LY3540378 Dose 3

Participants will receive LY3540378 SC.

Drug: LY3540378
Administered SC
Placebo Comparator: Placebo

Participants will be given placebo SC.

Drug: Placebo
Administered SC

Outcome Measures

Primary Outcome Measures

  1. Change from Baseline in Left Atrial Reservoir Strain (LARS) [Baseline, Week 26]

Secondary Outcome Measures

  1. Change from Baseline in N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) [Baseline, Week 26]

  2. Change from Baseline in Left Atrial End-Diastolic Volume Index (LAEDVI) [Baseline, Week 26]

  3. Change from Baseline Left Atrial End-Systolic Volume Index (LAESVI) [Baseline, Week 26]

  4. Change from Baseline in Estimated Glomerular Filtration Rate (eGFR) [Baseline, Week 26]

    eGFR calculated by creatinine and cystatin C

  5. Change from Baseline in Serum Creatinine [Baseline, Week 26]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Prior chronic treatment, or prescription, with a loop diuretic (for example, furosemide, torsemide, bumetanide) for ≥30 days prior to the index event. Index event is defined as a recent hospitalization for HF requiring at least 2 doses of intravenous diuretics or an out- of- hospital encounter (for example, Emergency Room, clinic visit, infusion clinic, etc.) for HF requiring at least 2 doses of intravenous diuretics.

  • Chronic HF diagnosed for at least 3 months before V1 (screening).

  • Documented LVEF of ≥50% within 6 months prior to screening; as measured by echocardiography, radionuclide ventriculography, invasive angiography, magnetic resonance imaging (MRI), or computerized tomograph (CT).

  • Had evidence of clinical HF syndrome consisting of

  • Hospitalization for HF within the past 2 weeks from randomization, 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 900 picograms/milliliter (pg/mL) [atrial fibrillation or atrial flutter] OR brain natriuretic (BNP) (>100 [sinus rhythm] or 300 pg/mL [atrial fibrillation or atrial flutter]) at screening.

Note: The presence or absence of atrial fibrillation or atrial flutter to determine the appropriate cut-off for a given BNP or NT-proBNP sample should be evaluated using electrocardiogram (ECG) performed at screening prior to the collection of the BNP or NT-proBNP sample.

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 day 2. (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 severe chronic obstructive pulmonary disease (COPD) as defined by chronic oxygen dependence. Night-time oxygen is not exclusionary.

  • Uncorrected thyroid disease.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pima Heart Tucson Arizona United States 85719
2 Valley Clinical Trials, Inc. Covina California United States 91723
3 Valley Clinical Trials, Inc. Northridge California United States 91325
4 University of California Irvine Medical Center Orange California United States 92868
5 Pasadena Clinical Research Pasadena California United States 91105
6 Clinnova Research - Redondo Beach Redondo Beach California United States 90277
7 Velocity Clinical Research, Coastal Heart Medical Group Santa Ana California United States 92704
8 Excel Medical Clinical Trials Boca Raton Florida United States 33434
9 Infinite Clinical Research Miami Florida United States 33133
10 South Florida Research Solutions - North Flamingo Road Pembroke Pines Florida United States 33028
11 Boston Medical Center Boston Massachusetts United States 02118
12 Henry Ford Hospital Detroit Michigan United States 48202
13 Abington Medical Specialists Abington Pennsylvania United States 19001
14 PharmaTex Research Amarillo Texas United States 79109
15 Baylor Scott & White Health-Advanced Heart and Lung Disease Dallas Texas United States 75246
16 UT Southwestern Medical Center Dallas Texas United States 75390
17 The University of Texas Medical Branch Galveston Texas United States 77555-0553
18 West Houston Area Clinical Trial Consultants Houston Texas United States 77094
19 Texas Institute of Cardiology, PA McKinney Texas United States 75071
20 Centro de Investigaciones Metabólicas (CINME) Ciudad Autónoma de Buenos Aire Buenos Air Argentina C1027AAP
21 Instituto de Investigaciones Clinicas Zarate Zárate Buenos Air Argentina B2800DGH
22 Investigaciones Medicas Imoba Srl Buenos Aires Ciudad Aut Argentina C1179AAB
23 Instituto Médico Río Cuarto Río Cuarto Córdoba Argentina 5800
24 Hospital Provincial del Centenario Rosario Santa Fe Argentina 2002
25 Investigaciones Clínicas Tucumán San Miguel de Tucuman Tucumán Argentina 4000
26 CEMEDIC Buenos Aires Argentina 1407
27 Fundación Respirar Buenos Aires Argentina C1426ABP
28 Hospital de Alta Complejidad "Pte. Juan Domingo Perón" Formosa Argentina 3600
29 Clínica de Nefrología, Urología y Enfermedades Cardiovasculares Santa Fe Argentina 3000
30 Centro de Investigaciones Clinicas del Litoral Santa Fe Argentina S3000FWO
31 Universidade Federal de Goias Goiania Goiás Brazil 74605-020
32 PUC Trials- Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR Curitiba Paraná Brazil 80230-130
33 Centro de Pesquisa Clinica do Coracao Acaraju Sergipe Brazil 49055-530
34 Centro de Pesquisa Sao Lucas Campinas São Paulo Brazil 13034-685
35 Instituto de Pesquisa clinica de Campinas Campinas São Paulo Brazil 13060-080
36 CAPED Centro Avancado Pesquisa e Diagnostica Ribeirao Preto São Paulo Brazil 14026-020
37 Pesquisare Saude Santo André São Paulo Brazil 09080-110
38 Hospital Santa Paula Sao Paulo São Paulo Brazil 04556-100
39 Incor - Instituto do Coracao Sao Paulo São Paulo Brazil 05403-900
40 Instituto de Molestias Cardiovasculares de Tatui Tatui São Paulo Brazil 18270-170
41 Hospital São Lucas de Copacabana Rio de Janeiro Brazil 22061-080
42 Misericordia Community Hospital Edmonton Alberta Canada T5R 4H5
43 North York Diagnostic and Cardiac Centre North York Ontario Canada M6B 3H7
44 Heart Health Institute - Scarborough Office Scarborough Ontario Canada M1B 4Z8
45 Fadia El Boreky Medicine Waterloo Ontario Canada N2J 1C4
46 Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ Szeged Csongrád Hungary 6720
47 Medifarma 98 Kft Nyiregyhaza Nyíregyháza Hungary 4400
48 Flor Ferenc Hospital of Pest County Kistarcsa Pest Hungary 2143
49 Belvárosi Egészségház Zalaegerszeg Zala Hungary 8900
50 Dél-Pesti Centrumkórház Budapest Hungary 1097
51 Semmelweis Egyetem Budapest Hungary 1122
52 Kasugai Municipal Hospital Kasugai Aichi Japan 486-8510
53 Saiseikai Futsukaichi Hospital Chikushino Fukuoka Japan 818-8516
54 Nakamura Cardiovascular Clinic Itoshima Fukuoka Japan 819-1104
55 National Hospital Organization Takasaki General Medical Centar Takasaki Gunma Japan 370-0829
56 Yokohama City University Medical Center Yokohama Kanagawa Japan 232-0024
57 Yokohama Minami Kyosai Hospital Yokohama Kanagawa Japan 236-0037
58 Minamino Cardiovascular Hospital Hachioji Tokyo Japan 192-0918
59 Ome Municipal General Hospital Ome Tokyo Japan 198-0042
60 Yamanashi Prefectural Central Hospital Kofu Yamanashi Japan 400-8506
61 Harasanshin Hospital Fukuoka Japan 812-0033
62 Rakuwakai Otowa Hospital Kyoto Japan 607-8062
63 National Hospotai Organization Okayama Medical Center Okayama Japan 701-1154
64 Sakurabashi Watanabe Hospital Osaka Japan 530-0001
65 Yodogawa Christian Hospital Osaka Japan 533-0024
66 National Hospital Organization - Osaka National Hospital - Institute For Clinical Research Osaka Japan 540-0006
67 Toyama Prefectural Central Hospital Toyama Japan 930-0975
68 NZOZ Centrum Medyczne KERmed Bydgoszcz Kujawsko-pomorskie Poland 85-231
69 INTERCOR Bydgoszcz Kujawsko-pomorskie Poland 85-605
70 CenterMed Lublin NZOZ Lublin Lubelskie Poland 20-044
71 Private Practice - Dr. Ewa Mirek Bryniarska Krakow Małopolskie Poland 30-082
72 MEDICOME Centrum Badań Klinicznych Oświęcimskie Oświęcim Małopolskie Poland 32-660
73 KLIMED Marek Klimkiewicz Białystok Podlaskie Poland 15-704
74 Szpital Św. Wincentego a Paulo Spółka Gdynia Pomorskie Poland 81-348
75 IRMED Osrodek Badan Klinicznych Piotrkow Trybunalski Łódzkie Poland 97-300
76 Provita Profamilia Piotrkow Trybunalski Łódzkie Poland 97-300
77 CHUS - Hospital Clinico Universitario Santiago de Compostela A Coruña [La Coruña] Spain 15706
78 Hu Reina Sofia Cordoba Andalucía Spain 14004
79 Hospital Universitario Virgen de Valme Sevilla Andalucía Spain 41014
80 Hospital Germans Trias i Pujol Badalona Barcelona [Barcelona] Spain 08916
81 Hospital Universitari de Bellvitge L'Hospitalet de Llobregat Catalunya [Cataluña] Spain 08907
82 Hospital San Juan de la Cruz Ubeda Jaén Spain 23400
83 Hospital Universitario Ramón y Cajal Madrid Madrid, Comunidad De Spain 28034
84 Hospital Clínico Universitario Virgen de la Arrixaca El Palmar, Murcia Murcia, Región De Spain 30120
85 Hospital Universitario Virgen de la Victoria Malaga Málaga Spain 29010
86 Hospital Clinico de Valencia Valencia Valenciana, Comunitat Spain 46010
87 Hospital Universitario 12 de Octubre Madrid Spain 28041
88 Wycombe General Hospital High Wycombe Buckinghamshire United Kingdom HP11 2TT
89 Northwick Park Hospital Harrow London, City Of United Kingdom HA1 3UJ
90 Glasgow Royal Infirmary Glasgow Scotland United Kingdom G31 2ER

Sponsors and Collaborators

  • Eli Lilly and Company

Investigators

  • Study Director: 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), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT05592275
Other Study ID Numbers:
  • 18473
  • J3E-MC-EZDB
  • 2022-000780-48
First Posted:
Oct 24, 2022
Last Update Posted:
Nov 17, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Heart Failure

Study Results

No Results Posted as of Nov 17, 2022