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 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
- ClinicalTrials.govNCT07761117Apri questa scheda su ClinicalTrials.govSincronizzato 2 settimane fa
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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.
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
| Sesso | Tutti |
|---|---|
| Età | 18 Years – Nessun massimo |
| Volontari sani | No |
Idoneità come riportata nel registro
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
| Tipo di studio | Interventistico |
|---|---|
| Fase | Fase 3 |
| Assegnazione | Randomizzata |
| Modello di intervento | PARALLEL |
| Finalità principale | TREATMENT |
| Mascheramento | QUADRUPLE (4) |
| Arruolamento | 6950 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
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
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
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
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
| Data di inizio | 24 agosto 2026 (effettiva) |
|---|---|
| Conclusione primaria | 3 settembre 2029 (stimata) |
| Conclusione | 3 settembre 2029 (stimata) |
| Prima pubblicazione | 12 agosto 2026 (effettiva) |
| Ultimo aggiornamento | 9 settembre 2026 |
| Risultati pubblicati | Non indicato nella scheda del registro |
| Stato verificato l'ultima volta | settembre 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
| Struttura | Città | Stato o regione | Stato |
|---|---|---|---|
| Research Site | Buenos Aires | Non ancora in reclutamento | |
| Research Site | CABA | Non ancora in reclutamento | |
| Research Site | Ciudad de Buenos Aires | Non ancora in reclutamento | |
| Research Site | Ciudad de Buenos Aires | Non ancora in reclutamento | |
| Research Site | Corrientes | Non ancora in reclutamento | |
| Research Site | Córdoba | Non ancora in reclutamento | |
| Research Site | Córdoba | Non ancora in reclutamento | |
| Research Site | Córdoba | Non ancora in reclutamento | |
| Research Site | Esperanza | Non ancora in reclutamento | |
| Research Site | Granadero Baigorria | Non ancora in reclutamento | |
| Research Site | Lanus | Non ancora in reclutamento | |
| Research Site | Mar del Plata | Non ancora in reclutamento | |
| Research Site | Mendoza | Non ancora in reclutamento | |
| Research Site | Rosario | Non ancora in reclutamento | |
| Research Site | Rosario | Non ancora in reclutamento | |
| Research Site | San Nicolás | Non ancora in reclutamento | |
| Research Site | Santa Fe | Non ancora in reclutamento |
Australia
| Struttura | Città | Stato o regione | Stato |
|---|---|---|---|
| Research Site | Blacktown | Non ancora in reclutamento | |
| Research Site | Campbelltown | Non ancora in reclutamento | |
| Research Site | Frankston | Non ancora in reclutamento | |
| Research Site | Hoppers Crossing | Non ancora in reclutamento | |
| Research Site | North Tamworth | Non ancora in reclutamento | |
| Research Site | Rockhampton | Non ancora in reclutamento |
Austria
| Struttura | Città | Stato o regione | Stato |
|---|---|---|---|
| Research Site | Bad Ischl | Non ancora in reclutamento | |
| Research Site | Feldkirch | Non ancora in reclutamento | |
| Research Site | Graz | Non ancora in reclutamento | |
| Research Site | Graz | Non ancora in reclutamento | |
| Research Site | Innsbruck | Non ancora in reclutamento | |
| Research Site | Klagenfurt | Non ancora in reclutamento | |
| Research Site | Linz | Non ancora in reclutamento | |
| Research Site | Saint Stefan/Stainz | Non ancora in reclutamento | |
| Research Site | Sankt Pölten | Non ancora in reclutamento | |
| Research Site | Vienna | Non ancora in reclutamento | |
| Research Site | Vienna | Non ancora in reclutamento | |
| Research Site | Vienna | Non ancora in reclutamento | |
| Research Site | Vienna | Non ancora in reclutamento | |
| Research Site | Wels | Non ancora in reclutamento |
Brazil
| Struttura | Città | Stato o regione | Stato |
|---|---|---|---|
| Research Site | Aracaju | Non ancora in reclutamento | |
| Research Site | Belém | Non ancora in reclutamento | |
| Research Site | Bragança Paulista | Non ancora in reclutamento | |
| Research Site | Brasília | Non ancora in reclutamento | |
| Research Site | Campinas | Non ancora in reclutamento | |
| Research Site | Curitiba | Non ancora in reclutamento | |
| Research Site | Joinville | Non ancora in reclutamento | |
| Research Site | Natal | Non ancora in reclutamento | |
| Research Site | Porto Alegre | Non ancora in reclutamento | |
| Research Site | Porto Alegre | Non ancora in reclutamento | |
| Research Site | Ribeirão Preto | Non ancora in reclutamento | |
| Research Site | Rio Branco | Non ancora in reclutamento | |
| Research Site | Rio de Janeiro | Non 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
- 9 settembre 2026
Stato modificato
Status changed from Not yet recruiting to Recruiting
NOT_YET_RECRUITINGRECRUITING
- 9 settembre 2026
Reclutamento aperto
Recruitment opened
NOT_YET_RECRUITINGRECRUITING
- 9 settembre 2026
Centro aggiunto
306 sites added (672 total)
366672