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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
Kontakter og lokationer
Studiekontakt
- Navn: Physicians interested in becoming principal investigators please contact
- E-mail: clinical_inquiry_hub@lilly.com
Undersøgelse Kontakt Backup
- Navn: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Telefonnummer: 317-615-4559
- E-mail: LillyTrials@Lilly.com
Studiesteder
-
-
California
-
Van Nuys, California, Forenede Stater, 91405
- InvivoCure LLC
-
Ledende efterforsker:
- Rodney Samaan
-
-
Florida
-
North Miami Beach, Florida, Forenede Stater, 33169
- Amavita Research Services, LLC
-
Ledende efterforsker:
- Pedro Martinez-Clark
-
-
Texas
-
Dallas, Texas, Forenede Stater, 75235
- Dharma PA d/b/a Southwest Family Medicine Associates
-
Ledende efterforsker:
- Chrisette Dharma
-
-
-
-
-
Caserta, Italien, 81100
- Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Sant' Anna e San Sebastiano di Caserta
-
Kontakt:
- Telefonnummer: 0823 23207475
-
Ledende efterforsker:
- Paolo Calabro
-
Torino, Italien, 10128
- A.O. Ordine Mauriziano di Torino
-
Ledende efterforsker:
- Giuseppe Musumeci
-
-
-
-
-
Krakow, Polen, 31-202
- Krakowski Szpital Specjalistyczny im. sw. Jana Pawla II
-
Ledende efterforsker:
- Pawel Rubis
-
Wroclaw, Polen, 50-981
- 4 Wojskowy Szpital Kliniczny z Poliklinika Samodzielny Publiczny ZOZ we Wroclawiu
-
Ledende efterforsker:
- Bartosz Krakowiak
-
Wroclaw, Polen, 50-556
- Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
-
Ledende efterforsker:
- Joanna Szachniewicz
-
-
-
-
-
Budapest, Ungarn, H-1122
- Semmelweis Egyetem - Varosmajori Sziv es Ergyogyaszati Klinika
-
Ledende efterforsker:
- Bela Merkely
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
-
Have New York Heart Association Class II to III heart failure
-
Have left ventricular ejection fraction (LVEF) ≥ 50%
-
KCCQ-CSS ≤ 80
-
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
-
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
-
Stable dose of heart failure medications
-
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 undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Bimagrumab Dose 1
Participants will receive bimagrumab subcutaneously (SC) |
Administered SC
Andre navne:
|
|
Eksperimentel: Bimagrumab Dose 2
Participants will receive bimagrumab SC |
Administered SC
Andre navne:
|
|
Placebo komparator: Placebo 1
Participants will receive placebo SC |
Administered SC |
|
Placebo komparator: Placebo 2
Participants will receive placebo SC |
Administered SC |
Hvad måler undersøgelsen?
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
|
|
Change from baseline in High-Sensitivity C-Reactive Protein (hs-CRP)
Tidsramme: Baseline, Week 52
|
Baseline, Week 52
|
|
Percentage of Participants who Achieve Responder Status for KCCQ-CSS
Tidsramme: Week 52
|
Week 52
|
|
Percentage of Participants who Achieve Responder Status for 6-Minute Walk Test Distance
Tidsramme: Week 52
|
Week 52
|
|
Change from Baseline in Early Transmitral Inflow Velocity / Early Diastolic Mitral Annular Velocity (E/e')
Tidsramme: Baseline, Week 52
|
Baseline, Week 52
|
|
Change from Baseline in Total Body Lean Mass
Tidsramme: Baseline, Week 52
|
Baseline, Week 52
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- 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
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 27879
- J4Z-MC-GIDK (Anden identifikator: Eli Lilly and Company)
- 2026-527983-34-00 (Ctis)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (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.
IPD-delingsadgangskriterier
A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .