A Study of Bimagrumab in Participants With HFpEF (ACTIVATE-HFpEF)
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study Comparing the Efficacy and Safety of Bimagrumab Versus Placebo in Patients With Heart Failure With Preserved Ejection Fraction (ACTIVATE-HFpEF)
This study will look at how bimagrumab affects adults who have a type of heart failure called HFpEF (heart failure with preserved ejection fraction), where the heart pumps normally but does not fill with blood as well as it should. Participation in the study will last about 76 weeks.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 2
Kontakter og plasseringer
Studiekontakt
- Navn: Physicians interested in becoming principal investigators please contact
- E-post: clinical_inquiry_hub@lilly.com
Studer Kontakt Backup
- Navn: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Telefonnummer: 317-615-4559
- E-post: LillyTrials@Lilly.com
Studiesteder
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California
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Van Nuys, California, Forente stater, 91405
- InvivoCure LLC
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Hovedetterforsker:
- Rodney Samaan
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Florida
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North Miami Beach, Florida, Forente stater, 33169
- Amavita Research Services, LLC
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Hovedetterforsker:
- Pedro Martinez-Clark
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Texas
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Dallas, Texas, Forente stater, 75235
- Dharma PA d/b/a Southwest Family Medicine Associates
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Hovedetterforsker:
- Chrisette Dharma
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-
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-
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Caserta, Italia, 81100
- Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Sant' Anna e San Sebastiano di Caserta
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Ta kontakt med:
- Telefonnummer: 0823 23207475
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Hovedetterforsker:
- Paolo Calabro
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Torino, Italia, 10128
- A.O. Ordine Mauriziano di Torino
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Hovedetterforsker:
- Giuseppe Musumeci
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Krakow, Polen, 31-202
- Krakowski Szpital Specjalistyczny im. sw. Jana Pawla II
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Hovedetterforsker:
- Pawel Rubis
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Wroclaw, Polen, 50-981
- 4 Wojskowy Szpital Kliniczny z Poliklinika Samodzielny Publiczny ZOZ we Wroclawiu
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Hovedetterforsker:
- Bartosz Krakowiak
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Wroclaw, Polen, 50-556
- Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
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Hovedetterforsker:
- Joanna Szachniewicz
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Budapest, Ungarn, H-1122
- Semmelweis Egyetem - Varosmajori Sziv es Ergyogyaszati Klinika
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Hovedetterforsker:
- Bela Merkely
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
-
Have New York Heart Association Class II to III heart failure
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Have left ventricular ejection fraction (LVEF) ≥ 50%
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KCCQ-CSS ≤ 80
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6MWD must be all of the following:
- ≥100 and ≤ 450 meters (m) based on average of 2 tests conducted at screening visit, AND
- ≥ 100 and ≤ 450 m on 1 test at randomization visit, AND
- < 20% change from average qualifying 6MWD obtained at screening
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Have documented evidence of at least one of the following:
- Heart failure event
- Elevated NT-proBNP (N-terminal pro B-type natriuretic peptide)
- Left atrium enlargement
- Elevated filling pressure
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Stable dose of heart failure medications
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Body mass index (BMI) ≥ 23 kilograms per meter squared (kg/m²)
Exclusion Criteria:
- Heart failure hospitalization < 4 weeks before screening
- Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery/intervention, stroke or transient ischemic attack in past 12 weeks prior to screening, or unstable angina pectoris in past 4 weeks prior to screening or during screening
- Type 1 diabetes
- Hemoglobin A1c (HbA1c) ≥ 9.5%
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Bimagrumab Dose 1
Participants will receive bimagrumab subcutaneously (SC) |
Administered SC
Andre navn:
|
|
Eksperimentell: Bimagrumab Dose 2
Participants will receive bimagrumab SC |
Administered SC
Andre navn:
|
|
Placebo komparator: Placebo 1
Participants will receive placebo SC |
Administered SC |
|
Placebo komparator: Placebo 2
Participants will receive placebo SC |
Administered SC |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change from Baseline in the Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS)
Tidsramme: Baseline, Week 52
|
Baseline, Week 52
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change from Baseline in the 6-Minute Walk Test Distance (6MWD)
Tidsramme: Baseline, Week 52
|
Baseline, Week 52
|
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Change from baseline in High-Sensitivity C-Reactive Protein (hs-CRP)
Tidsramme: Baseline, Week 52
|
Baseline, Week 52
|
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Percentage of Participants who Achieve Responder Status for KCCQ-CSS
Tidsramme: Week 52
|
Week 52
|
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Percentage of Participants who Achieve Responder Status for 6-Minute Walk Test Distance
Tidsramme: Week 52
|
Week 52
|
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Change from Baseline in Early Transmitral Inflow Velocity / Early Diastolic Mitral Annular Velocity (E/e')
Tidsramme: Baseline, Week 52
|
Baseline, Week 52
|
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Change from Baseline in Total Body Lean Mass
Tidsramme: Baseline, Week 52
|
Baseline, Week 52
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 27879
- J4Z-MC-GIDK (Annen identifikator: Eli Lilly and Company)
- 2026-527983-34-00 (Ctis)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD-delingstidsramme
Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Tilgangskriterier for IPD-deling
A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
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