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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)

En recrutementAccepte des participants actuellement, selon la fiche du registre.
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En bref

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…

Phase 36 950 participants recherchés672 sites32 pays

Catégories

Enregistré dans 1 registre

Une même étude peut être enregistrée dans plusieurs registres. Nous l'affichons une seule fois et renvoyons vers chaque fiche que nous détenons.

Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

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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.

Résumé

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.

Affections

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

Éligibilité

Éligibilité
SexeTous
Âges18 YearsAucun maximum
Volontaires sainsNon

Éligibilité telle qu'elle figure dans le registre

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.

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Conception de l'étude
Type d'étudeInterventionnelle
PhasePhase 3
RépartitionRandomisée
Modèle d'interventionPARALLEL
Objectif principalTREATMENT
InsuQUADRUPLE (4)
Recrutement6 950 participants recherchés

Promoteur et collaborateurs

  • AstraZeneca Promoteur

Groupes et interventions

  • ElecoglipronEXPERIMENTAL

    Elecoglipron tablet once daily

  • PlaceboACTIVE_COMPARATOR

    Placebo matching Elecoglipron tablet once daily

Interventions

  • Médicament Elecoglipron

    Elecoglipron tablet

  • Médicament Placebo

    Placebo tablet

Critères de jugement

  1. Critère de jugement 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

    Délai Up to 42 months

  2. Critère de jugement secondaire

    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

    Délai Up to 42 months

  3. Critère de jugement secondaire

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

    Change from baseline to Week 52

    Délai Baseline and 52 weeks

  4. Critère de jugement secondaire

    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

    Délai Up to 42 months

Dates

Dates
Date de début24 août 2026 (réelle)
Achèvement principal3 septembre 2029 (estimée)
Achèvement3 septembre 2029 (estimée)
Première publication12 août 2026 (réelle)
Dernière mise à jour9 septembre 2026
Résultats publiésNon précisé dans la fiche du registre
Statut vérifié pour la dernière foisseptembre 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

11 sites sont en recrutement

Argentina

Argentina
ÉtablissementVilleÉtat ou régionStatut
Research SiteBuenos AiresPas encore en recrutement
Research SiteCABAPas encore en recrutement
Research SiteCiudad de Buenos AiresPas encore en recrutement
Research SiteCiudad de Buenos AiresPas encore en recrutement
Research SiteCorrientesPas encore en recrutement
Research SiteCórdobaPas encore en recrutement
Research SiteCórdobaPas encore en recrutement
Research SiteCórdobaPas encore en recrutement
Research SiteEsperanzaPas encore en recrutement
Research SiteGranadero BaigorriaPas encore en recrutement
Research SiteLanusPas encore en recrutement
Research SiteMar del PlataPas encore en recrutement
Research SiteMendozaPas encore en recrutement
Research SiteRosarioPas encore en recrutement
Research SiteRosarioPas encore en recrutement
Research SiteSan NicolásPas encore en recrutement
Research SiteSanta FePas encore en recrutement

Australia

Australia
ÉtablissementVilleÉtat ou régionStatut
Research SiteBlacktownPas encore en recrutement
Research SiteCampbelltownPas encore en recrutement
Research SiteFrankstonPas encore en recrutement
Research SiteHoppers CrossingPas encore en recrutement
Research SiteNorth TamworthPas encore en recrutement
Research SiteRockhamptonPas encore en recrutement

Austria

Austria
ÉtablissementVilleÉtat ou régionStatut
Research SiteBad IschlPas encore en recrutement
Research SiteFeldkirchPas encore en recrutement
Research SiteGrazPas encore en recrutement
Research SiteGrazPas encore en recrutement
Research SiteInnsbruckPas encore en recrutement
Research SiteKlagenfurtPas encore en recrutement
Research SiteLinzPas encore en recrutement
Research SiteSaint Stefan/StainzPas encore en recrutement
Research SiteSankt PöltenPas encore en recrutement
Research SiteViennaPas encore en recrutement
Research SiteViennaPas encore en recrutement
Research SiteViennaPas encore en recrutement
Research SiteViennaPas encore en recrutement
Research SiteWelsPas encore en recrutement

Brazil

Brazil
ÉtablissementVilleÉtat ou régionStatut
Research SiteAracajuPas encore en recrutement
Research SiteBelémPas encore en recrutement
Research SiteBragança PaulistaPas encore en recrutement
Research SiteBrasíliaPas encore en recrutement
Research SiteCampinasPas encore en recrutement
Research SiteCuritibaPas encore en recrutement
Research SiteJoinvillePas encore en recrutement
Research SiteNatalPas encore en recrutement
Research SitePorto AlegrePas encore en recrutement
Research SitePorto AlegrePas encore en recrutement
Research SiteRibeirão PretoPas encore en recrutement
Research SiteRio BrancoPas encore en recrutement
Research SiteRio de JaneiroPas encore en recrutement

622 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

  1. 9 septembre 2026

    Statut modifié

    Status changed from Not yet recruiting to Recruiting

    NOT_YET_RECRUITINGRECRUITING

  2. 9 septembre 2026

    Recrutement ouvert

    Recruitment opened

    NOT_YET_RECRUITINGRECRUITING

  3. 9 septembre 2026

    Site ajouté

    306 sites added (672 total)

    366672