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 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
- ClinicalTrials.govNCT07761117Ouvrir cette fiche sur ClinicalTrials.govSynchronisé il y a 2 semaines
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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.
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
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
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
| Sexe | Tous |
|---|---|
| Âges | 18 Years – Aucun maximum |
| Volontaires sains | Non |
Éligibilité telle qu'elle figure dans le registre
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
| Type d'étude | Interventionnelle |
|---|---|
| Phase | Phase 3 |
| Répartition | Randomisée |
| Modèle d'intervention | PARALLEL |
| Objectif principal | TREATMENT |
| Insu | QUADRUPLE (4) |
| Recrutement | 6 950 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
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
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
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
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
| Date de début | 24 août 2026 (réelle) |
|---|---|
| Achèvement principal | 3 septembre 2029 (estimée) |
| Achèvement | 3 septembre 2029 (estimée) |
| Première publication | 12 août 2026 (réelle) |
| Dernière mise à jour | 9 septembre 2026 |
| Résultats publiés | Non précisé dans la fiche du registre |
| Statut vérifié pour la dernière fois | septembre 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
| Établissement | Ville | État ou région | Statut |
|---|---|---|---|
| Research Site | Buenos Aires | Pas encore en recrutement | |
| Research Site | CABA | Pas encore en recrutement | |
| Research Site | Ciudad de Buenos Aires | Pas encore en recrutement | |
| Research Site | Ciudad de Buenos Aires | Pas encore en recrutement | |
| Research Site | Corrientes | Pas encore en recrutement | |
| Research Site | Córdoba | Pas encore en recrutement | |
| Research Site | Córdoba | Pas encore en recrutement | |
| Research Site | Córdoba | Pas encore en recrutement | |
| Research Site | Esperanza | Pas encore en recrutement | |
| Research Site | Granadero Baigorria | Pas encore en recrutement | |
| Research Site | Lanus | Pas encore en recrutement | |
| Research Site | Mar del Plata | Pas encore en recrutement | |
| Research Site | Mendoza | Pas encore en recrutement | |
| Research Site | Rosario | Pas encore en recrutement | |
| Research Site | Rosario | Pas encore en recrutement | |
| Research Site | San Nicolás | Pas encore en recrutement | |
| Research Site | Santa Fe | Pas encore en recrutement |
Australia
| Établissement | Ville | État ou région | Statut |
|---|---|---|---|
| Research Site | Blacktown | Pas encore en recrutement | |
| Research Site | Campbelltown | Pas encore en recrutement | |
| Research Site | Frankston | Pas encore en recrutement | |
| Research Site | Hoppers Crossing | Pas encore en recrutement | |
| Research Site | North Tamworth | Pas encore en recrutement | |
| Research Site | Rockhampton | Pas encore en recrutement |
Austria
| Établissement | Ville | État ou région | Statut |
|---|---|---|---|
| Research Site | Bad Ischl | Pas encore en recrutement | |
| Research Site | Feldkirch | Pas encore en recrutement | |
| Research Site | Graz | Pas encore en recrutement | |
| Research Site | Graz | Pas encore en recrutement | |
| Research Site | Innsbruck | Pas encore en recrutement | |
| Research Site | Klagenfurt | Pas encore en recrutement | |
| Research Site | Linz | Pas encore en recrutement | |
| Research Site | Saint Stefan/Stainz | Pas encore en recrutement | |
| Research Site | Sankt Pölten | Pas encore en recrutement | |
| Research Site | Vienna | Pas encore en recrutement | |
| Research Site | Vienna | Pas encore en recrutement | |
| Research Site | Vienna | Pas encore en recrutement | |
| Research Site | Vienna | Pas encore en recrutement | |
| Research Site | Wels | Pas encore en recrutement |
Brazil
| Établissement | Ville | État ou région | Statut |
|---|---|---|---|
| Research Site | Aracaju | Pas encore en recrutement | |
| Research Site | Belém | Pas encore en recrutement | |
| Research Site | Bragança Paulista | Pas encore en recrutement | |
| Research Site | Brasília | Pas encore en recrutement | |
| Research Site | Campinas | Pas encore en recrutement | |
| Research Site | Curitiba | Pas encore en recrutement | |
| Research Site | Joinville | Pas encore en recrutement | |
| Research Site | Natal | Pas encore en recrutement | |
| Research Site | Porto Alegre | Pas encore en recrutement | |
| Research Site | Porto Alegre | Pas encore en recrutement | |
| Research Site | Ribeirão Preto | Pas encore en recrutement | |
| Research Site | Rio Branco | Pas encore en recrutement | |
| Research Site | Rio de Janeiro | Pas 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
- 9 septembre 2026
Statut modifié
Status changed from Not yet recruiting to Recruiting
NOT_YET_RECRUITINGRECRUITING
- 9 septembre 2026
Recrutement ouvert
Recruitment opened
NOT_YET_RECRUITINGRECRUITING
- 9 septembre 2026
Site ajouté
306 sites added (672 total)
366672