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NCT07761117ClinicalTrials.gov

A Study to Investigate CV Outcomes With Elecoglipron Compared With Placebo in Adult Participants With HFpEF or HFmrEF

A Phase III, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Study to Evaluate the Effect of Elecoglipron in Reducing Cardiovascular Outcomes in Participants With HFpEF and HFmrEF (Elevate-HF)

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En resumen

This is a Phase III, randomized, double-blind, parallel-group, placebo-controlled, multicenter study to investigate CV outcomes with elecoglipron compared with placebo, in adults with heart failure with preserved ejection fraction (HFpEF)/heart failure with mildly reduced ejection fraction (HFmrEF), irrespective of T2DM…

Fase 36950 participantes buscados672 centros32 países

Categorías

Registrado en 1 registro

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La información del ensayo se muestra tal como la publicó el registro, en su idioma original.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Present: Registered before enrolment beganFirst posted 2026-08-12; recorded start 2026-08-24
  • Present: Has a defined primary outcomeA primary outcome measure is listed in the record
  • Present: The primary outcome states a time frameThe primary outcome measure records a time frame
  • Present: Participants are randomly assignedAllocation is recorded as randomised
  • Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Present: Uses blinding (masking)A masking level is recorded in the record
  • Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Present: Sponsor has 1019 other studies in this databaseCounted from the lead sponsor named in the record (AstraZeneca)
  • Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
  • The record lists 2 conditions.
  • Lead sponsor type recorded as: industry.
  • Intervention regulatory context: investigational, within a phased regulatory pathway.

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourDEFINITIVE

A definitive-grade design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation20/20

    Participants are randomly allocated between arms

  • Blinding20/20

    Quadruple-blind

  • Control arm15/15

    Active-comparator control arm

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type10/10

    Mortality / MACE endpoint (hard clinical outcome)

  • Multi-centre8/8

    Multi-centre: 366 sites

  • Data monitoring committee7/7

    A data monitoring committee is in place

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleLARGE

A large study, international in scope: 6,950 participants (target), run at 672 sites, across 32 countries.

How this score is built
  • Enrolment37/40

    6,950 participants (target)

  • Site count25/25

    366 sites

  • Country count15/15

    25 countries

  • Planned duration8/10

    Planned over about 37 months

  • Sponsor scale10/10

    AstraZeneca has led 1,005 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Resumen

This is a Phase III, randomized, double-blind, parallel-group, placebo-controlled, multicenter study to investigate CV outcomes with elecoglipron compared with placebo, in adults with heart failure with preserved ejection fraction (HFpEF)/heart failure with mildly reduced ejection fraction (HFmrEF), irrespective of T2DM status, and who are on background dapagliflozin in addition to other background standard of care.

Afecciones

  • Heart Failure With Preserved Ejection Fraction (HFpEF)
  • Heart Failure With Mildly Reduced Ejection Fraction (HFmrEF)

Elegibilidad

Elegibilidad
SexoTodos
Edades18 YearsSin máximo
Voluntarios sanosNo

Elegibilidad tal como figura en el registro

Inclusion Criteria: * Left ventricular ejection fraction (LVEF) of \> 40% within 12 months prior to screening. * Structural heart disease evidence. * HF diagnosed with New York Heart Association (NYHA) Class II-IV at the time of screening. Exclusion Criteria: * BMI \<25 kg/m² at screening. * Diabetes exclusions: * History of type 1 diabetes. * HbA1c ≥10% at screening. * Currently receiving or anticipated to receive therapeutic intervention for diabetic retinopathy and/or macular edema. * more than 1 episode of severe hypoglycemic event within 180 days prior to screening, or hypoglycemia unawareness/poor recognition. * Renal exclusions: * On a prespecified renal replacement therapy, or eGFR below a prespecified threshold at screening * Cardiovascular exclusions: * Major cardiac surgery, coronary revascularization, valvular repair/replacement, AF/AFL ablation, CRT implantation, or ICD without CRT within 90 days prior to screening, or planned after randomization. * Heart failure due to infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, genetic hypertrophic cardiomyopathy (including obstructive), or arrhythmogenic right ventricular cardiomyopathy/dysplasia. * GI exclusions: * Clinically significant upper GI condition affecting gastric emptying, drug absorption, or safety/tolerability interpretation; chronic use of drugs directly affecting GI motility; severe disease or prior surgery. * History of acute or chronic pancreatitis. * Endocrine exclusions: * History/ family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2, or basal calcitonin ≥35 ng/L at screening.

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Diseño del estudio
Tipo de estudioDe intervención
FaseFase 3
AsignaciónAleatorizado
Modelo de intervenciónPARALLEL
Propósito principalTREATMENT
EnmascaramientoQUADRUPLE (4)
Inscripción6950 participantes buscados

Patrocinador y colaboradores

  • AstraZeneca Patrocinador

Grupos e intervenciones

  • ElecoglipronEXPERIMENTAL

    Elecoglipron tablet once daily

  • PlaceboACTIVE_COMPARATOR

    Placebo matching Elecoglipron tablet once daily

Intervenciones

  • Fármaco Elecoglipron

    Elecoglipron tablet

  • Fármaco Placebo

    Placebo tablet

Variables de resultado

  1. Variable de resultado principal

    To evaluate the effect of elecoglipron compared with placebo in reducing the risk of CV death or HHF/urgent HF visit

    Time to first event of the composite of: * CV death * HHF * Urgent HF visit

    Plazo Up to 42 months

  2. Variable de resultado secundaria

    To evaluate the effect of elecoglipron compared with placebo in reducing the rate of HF events (HHF or urgent HF visit)

    Total occurrences (first and recurrent) of: * HF events * HHF * Urgent HF visit

    Plazo Up to 42 months

  3. Variable de resultado secundaria

    To evaluate the effect of elecoglipron compared to placebo on improving patient-reported outcomes using a questionnaire.

    Change from baseline to Week 52

    Plazo Baseline and 52 weeks

  4. Variable de resultado secundaria

    To evaluate the effect of elecoglipron compared with placebo in reducing the risk of the 4-point composite of all-cause death, HHF, MI, or stroke

    Time to first event of the composite of: * All-cause death * HHF * MI * Stroke

    Plazo Up to 42 months

Fechas

Fechas
Fecha de inicio24 de agosto de 2026 (real)
Finalización principal3 de septiembre de 2029 (estimada)
Finalización3 de septiembre de 2029 (estimada)
Primera publicación12 de agosto de 2026 (real)
Última actualización9 de septiembre de 2026
Resultados publicadosNo indicado en el registro
Estado verificado por última vezseptiembre de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

11 centros están en reclutamiento

Argentina

Argentina
CentroCiudadEstado o regiónEstado
Research SiteBuenos AiresAún no recluta
Research SiteCABAAún no recluta
Research SiteCiudad de Buenos AiresAún no recluta
Research SiteCiudad de Buenos AiresAún no recluta
Research SiteCorrientesAún no recluta
Research SiteCórdobaAún no recluta
Research SiteCórdobaAún no recluta
Research SiteCórdobaAún no recluta
Research SiteEsperanzaAún no recluta
Research SiteGranadero BaigorriaAún no recluta
Research SiteLanusAún no recluta
Research SiteMar del PlataAún no recluta
Research SiteMendozaAún no recluta
Research SiteRosarioAún no recluta
Research SiteRosarioAún no recluta
Research SiteSan NicolásAún no recluta
Research SiteSanta FeAún no recluta

Australia

Australia
CentroCiudadEstado o regiónEstado
Research SiteBlacktownAún no recluta
Research SiteCampbelltownAún no recluta
Research SiteFrankstonAún no recluta
Research SiteHoppers CrossingAún no recluta
Research SiteNorth TamworthAún no recluta
Research SiteRockhamptonAún no recluta

Austria

Austria
CentroCiudadEstado o regiónEstado
Research SiteBad IschlAún no recluta
Research SiteFeldkirchAún no recluta
Research SiteGrazAún no recluta
Research SiteGrazAún no recluta
Research SiteInnsbruckAún no recluta
Research SiteKlagenfurtAún no recluta
Research SiteLinzAún no recluta
Research SiteSaint Stefan/StainzAún no recluta
Research SiteSankt PöltenAún no recluta
Research SiteViennaAún no recluta
Research SiteViennaAún no recluta
Research SiteViennaAún no recluta
Research SiteViennaAún no recluta
Research SiteWelsAún no recluta

Brazil

Brazil
CentroCiudadEstado o regiónEstado
Research SiteAracajuAún no recluta
Research SiteBelémAún no recluta
Research SiteBragança PaulistaAún no recluta
Research SiteBrasíliaAún no recluta
Research SiteCampinasAún no recluta
Research SiteCuritibaAún no recluta
Research SiteJoinvilleAún no recluta
Research SiteNatalAún no recluta
Research SitePorto AlegreAún no recluta
Research SitePorto AlegreAún no recluta
Research SiteRibeirão PretoAún no recluta
Research SiteRio BrancoAún no recluta
Research SiteRio de JaneiroAún no recluta

En el registro figuran 622 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

  1. 9 de septiembre de 2026

    Estado modificado

    Status changed from Not yet recruiting to Recruiting

    NOT_YET_RECRUITINGRECRUITING

  2. 9 de septiembre de 2026

    Reclutamiento abierto

    Recruitment opened

    NOT_YET_RECRUITINGRECRUITING

  3. 9 de septiembre de 2026

    Centro añadido

    306 sites added (672 total)

    366672