Vai al contenuto principale
xMedica

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)

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.
Contatta questo studio

In breve

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 partecipanti ricercati672 centri32 paesi

Categorie

Registrato in 1 registro

Uno studio può essere registrato in più registri. Lo mostriamo una volta sola e colleghiamo ogni scheda in nostro possesso.

Le informazioni sulla sperimentazione sono mostrate così come pubblicate dal registro, nella lingua originale.

Ti interessa questo studio?

Accedi oppure crea un account per registrare il tuo interesse e seguire questo studio.

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.

Sintesi

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.

Patologie

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

Idoneità

Idoneità
SessoTutti
Età18 YearsNessun massimo
Volontari saniNo

Idoneità come riportata nel 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.

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Disegno dello studio
Tipo di studioInterventistico
FaseFase 3
AssegnazioneRandomizzata
Modello di interventoPARALLEL
Finalità principaleTREATMENT
MascheramentoQUADRUPLE (4)
Arruolamento6950 partecipanti ricercati

Sponsor e collaboratori

  • AstraZeneca Sponsor

Bracci e interventi

  • ElecoglipronEXPERIMENTAL

    Elecoglipron tablet once daily

  • PlaceboACTIVE_COMPARATOR

    Placebo matching Elecoglipron tablet once daily

Interventi

  • Farmaco Elecoglipron

    Elecoglipron tablet

  • Farmaco Placebo

    Placebo tablet

Esiti misurati

  1. Esito primario

    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

    Orizzonte temporale Up to 42 months

  2. Esito secondario

    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

    Orizzonte temporale Up to 42 months

  3. Esito secondario

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

    Change from baseline to Week 52

    Orizzonte temporale Baseline and 52 weeks

  4. Esito secondario

    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

    Orizzonte temporale Up to 42 months

Date

Date
Data di inizio24 agosto 2026 (effettiva)
Conclusione primaria3 settembre 2029 (stimata)
Conclusione3 settembre 2029 (stimata)
Prima pubblicazione12 agosto 2026 (effettiva)
Ultimo aggiornamento9 settembre 2026
Risultati pubblicatiNon indicato nella scheda del registro
Stato verificato l'ultima voltasettembre 2026

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

11 centri stanno reclutando

Argentina

Argentina
StrutturaCittàStato o regioneStato
Research SiteBuenos AiresNon ancora in reclutamento
Research SiteCABANon ancora in reclutamento
Research SiteCiudad de Buenos AiresNon ancora in reclutamento
Research SiteCiudad de Buenos AiresNon ancora in reclutamento
Research SiteCorrientesNon ancora in reclutamento
Research SiteCórdobaNon ancora in reclutamento
Research SiteCórdobaNon ancora in reclutamento
Research SiteCórdobaNon ancora in reclutamento
Research SiteEsperanzaNon ancora in reclutamento
Research SiteGranadero BaigorriaNon ancora in reclutamento
Research SiteLanusNon ancora in reclutamento
Research SiteMar del PlataNon ancora in reclutamento
Research SiteMendozaNon ancora in reclutamento
Research SiteRosarioNon ancora in reclutamento
Research SiteRosarioNon ancora in reclutamento
Research SiteSan NicolásNon ancora in reclutamento
Research SiteSanta FeNon ancora in reclutamento

Australia

Australia
StrutturaCittàStato o regioneStato
Research SiteBlacktownNon ancora in reclutamento
Research SiteCampbelltownNon ancora in reclutamento
Research SiteFrankstonNon ancora in reclutamento
Research SiteHoppers CrossingNon ancora in reclutamento
Research SiteNorth TamworthNon ancora in reclutamento
Research SiteRockhamptonNon ancora in reclutamento

Austria

Austria
StrutturaCittàStato o regioneStato
Research SiteBad IschlNon ancora in reclutamento
Research SiteFeldkirchNon ancora in reclutamento
Research SiteGrazNon ancora in reclutamento
Research SiteGrazNon ancora in reclutamento
Research SiteInnsbruckNon ancora in reclutamento
Research SiteKlagenfurtNon ancora in reclutamento
Research SiteLinzNon ancora in reclutamento
Research SiteSaint Stefan/StainzNon ancora in reclutamento
Research SiteSankt PöltenNon ancora in reclutamento
Research SiteViennaNon ancora in reclutamento
Research SiteViennaNon ancora in reclutamento
Research SiteViennaNon ancora in reclutamento
Research SiteViennaNon ancora in reclutamento
Research SiteWelsNon ancora in reclutamento

Brazil

Brazil
StrutturaCittàStato o regioneStato
Research SiteAracajuNon ancora in reclutamento
Research SiteBelémNon ancora in reclutamento
Research SiteBragança PaulistaNon ancora in reclutamento
Research SiteBrasíliaNon ancora in reclutamento
Research SiteCampinasNon ancora in reclutamento
Research SiteCuritibaNon ancora in reclutamento
Research SiteJoinvilleNon ancora in reclutamento
Research SiteNatalNon ancora in reclutamento
Research SitePorto AlegreNon ancora in reclutamento
Research SitePorto AlegreNon ancora in reclutamento
Research SiteRibeirão PretoNon ancora in reclutamento
Research SiteRio BrancoNon ancora in reclutamento
Research SiteRio de JaneiroNon ancora in reclutamento

Nella scheda del registro sono indicati altri 622 centri.

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

  1. 9 settembre 2026

    Stato modificato

    Status changed from Not yet recruiting to Recruiting

    NOT_YET_RECRUITINGRECRUITING

  2. 9 settembre 2026

    Reclutamento aperto

    Recruitment opened

    NOT_YET_RECRUITINGRECRUITING

  3. 9 settembre 2026

    Centro aggiunto

    306 sites added (672 total)

    366672