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 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
- ClinicalTrials.govNCT07761117Abrir este registro en ClinicalTrials.govSincronizado hace 2 semanas
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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.
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
| Sexo | Todos |
|---|---|
| Edades | 18 Years – Sin máximo |
| Voluntarios sanos | No |
Elegibilidad tal como figura en el registro
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
| Tipo de estudio | De intervención |
|---|---|
| Fase | Fase 3 |
| Asignación | Aleatorizado |
| Modelo de intervención | PARALLEL |
| Propósito principal | TREATMENT |
| Enmascaramiento | QUADRUPLE (4) |
| Inscripción | 6950 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
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
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
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
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
| Fecha de inicio | 24 de agosto de 2026 (real) |
|---|---|
| Finalización principal | 3 de septiembre de 2029 (estimada) |
| Finalización | 3 de septiembre de 2029 (estimada) |
| Primera publicación | 12 de agosto de 2026 (real) |
| Última actualización | 9 de septiembre de 2026 |
| Resultados publicados | No indicado en el registro |
| Estado verificado por última vez | septiembre 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
| Centro | Ciudad | Estado o región | Estado |
|---|---|---|---|
| Research Site | Buenos Aires | Aún no recluta | |
| Research Site | CABA | Aún no recluta | |
| Research Site | Ciudad de Buenos Aires | Aún no recluta | |
| Research Site | Ciudad de Buenos Aires | Aún no recluta | |
| Research Site | Corrientes | Aún no recluta | |
| Research Site | Córdoba | Aún no recluta | |
| Research Site | Córdoba | Aún no recluta | |
| Research Site | Córdoba | Aún no recluta | |
| Research Site | Esperanza | Aún no recluta | |
| Research Site | Granadero Baigorria | Aún no recluta | |
| Research Site | Lanus | Aún no recluta | |
| Research Site | Mar del Plata | Aún no recluta | |
| Research Site | Mendoza | Aún no recluta | |
| Research Site | Rosario | Aún no recluta | |
| Research Site | Rosario | Aún no recluta | |
| Research Site | San Nicolás | Aún no recluta | |
| Research Site | Santa Fe | Aún no recluta |
Australia
| Centro | Ciudad | Estado o región | Estado |
|---|---|---|---|
| Research Site | Blacktown | Aún no recluta | |
| Research Site | Campbelltown | Aún no recluta | |
| Research Site | Frankston | Aún no recluta | |
| Research Site | Hoppers Crossing | Aún no recluta | |
| Research Site | North Tamworth | Aún no recluta | |
| Research Site | Rockhampton | Aún no recluta |
Austria
| Centro | Ciudad | Estado o región | Estado |
|---|---|---|---|
| Research Site | Bad Ischl | Aún no recluta | |
| Research Site | Feldkirch | Aún no recluta | |
| Research Site | Graz | Aún no recluta | |
| Research Site | Graz | Aún no recluta | |
| Research Site | Innsbruck | Aún no recluta | |
| Research Site | Klagenfurt | Aún no recluta | |
| Research Site | Linz | Aún no recluta | |
| Research Site | Saint Stefan/Stainz | Aún no recluta | |
| Research Site | Sankt Pölten | Aún no recluta | |
| Research Site | Vienna | Aún no recluta | |
| Research Site | Vienna | Aún no recluta | |
| Research Site | Vienna | Aún no recluta | |
| Research Site | Vienna | Aún no recluta | |
| Research Site | Wels | Aún no recluta |
Brazil
| Centro | Ciudad | Estado o región | Estado |
|---|---|---|---|
| Research Site | Aracaju | Aún no recluta | |
| Research Site | Belém | Aún no recluta | |
| Research Site | Bragança Paulista | Aún no recluta | |
| Research Site | Brasília | Aún no recluta | |
| Research Site | Campinas | Aún no recluta | |
| Research Site | Curitiba | Aún no recluta | |
| Research Site | Joinville | Aún no recluta | |
| Research Site | Natal | Aún no recluta | |
| Research Site | Porto Alegre | Aún no recluta | |
| Research Site | Porto Alegre | Aún no recluta | |
| Research Site | Ribeirão Preto | Aún no recluta | |
| Research Site | Rio Branco | Aún no recluta | |
| Research Site | Rio de Janeiro | Aún 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
- 9 de septiembre de 2026
Estado modificado
Status changed from Not yet recruiting to Recruiting
NOT_YET_RECRUITINGRECRUITING
- 9 de septiembre de 2026
Reclutamiento abierto
Recruitment opened
NOT_YET_RECRUITINGRECRUITING
- 9 de septiembre de 2026
Centro añadido
306 sites added (672 total)
366672