NCT07662044ClinicalTrials.gov
A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Alone or in Combination With Dapagliflozin Compared With Placebo in Adults With Type 2 Diabetes Mellitus
A Randomized, Double-blind, Parallel-group Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Elecoglipron Alone or in Combination With Dapagliflozin Compared With Placebo in Adults With Type 2 Diabetes Mellitus (Eluminate-1)
En resumen
The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron alone or in combination with dapagliflozin compared with placebo in adults with type 2 diabetes mellitus (T2DM) inadequately managed with lifestyle management alone or treated…
Fase 3800 participantes buscados149 centros13 países
Categorías
Registrado en 1 registro
- ClinicalTrials.govNCT07662044Abrir este registro en ClinicalTrials.govSincronizado hace 3 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 2026-06-23; recorded start 2026-07-06
- 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 1 condition.
- 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 strong methodological 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 arm13/15
Placebo / sham control arm
- Primary-outcome specificity10/10
Named primary outcome with a defined time frame
- Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
- Multi-centre8/8
Multi-centre: 149 sites
- Data monitoring committee0/7
No data monitoring committee stated
- 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: 800 participants (target), run at 149 sites, across 13 countries.
How this score is built
- Enrolment29/40
800 participants (target)
- Site count24/25
149 sites
- Country count12/15
13 countries
- Planned duration7/10
Planned over about 25 months
- Sponsor scale10/10
AstraZeneca has led 991 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
The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron alone or in combination with dapagliflozin compared with placebo in adults with type 2 diabetes mellitus (T2DM) inadequately managed with lifestyle management alone or treated with other background glucose-lowering medication.
Afecciones
- Type 2 Diabetes Mellitus
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 | 800 participantes buscados |
Patrocinador y colaboradores
- AstraZeneca Patrocinador
Grupos e intervenciones
- Elecoglipron dose level 1 + dapagliflozin-matched placeboEXPERIMENTAL
Participants will receive elecoglipron at dose level 1 and dapagliflozin-matched placebo, administered orally once daily.
- Elecoglipron dose level 2 + dapagliflozin-matched placeboEXPERIMENTAL
Participants will receive elecoglipron at dose level 2 and dapagliflozin-matched placebo, administered orally once daily.
- Elecoglipron (one of the studied dose levels) + dapagliflozinEXPERIMENTAL
Participants will receive elecoglipron at one of the study dose levels in combination with dapagliflozin, administered orally once daily.
- Elecoglipron-matched placebo + dapagliflozin-matched placeboPLACEBO_COMPARATOR
Participants will receive elecoglipron-matched placebo and dapagliflozin-matched placebo, administered orally once daily.
Intervenciones
- Fármaco Dapagliflozin
Dapagliflozin administered orally once daily.
- Fármaco Dapagliflozin-matched placebo
A placebo matching dapagliflozin, administered orally once daily.
- Fármaco Elecoglipron
Elecoglipron is administered orally once daily.
- Fármaco Elecoglipron-matched placebo
A placebo matching elecoglipron, administered orally once daily.
Variables de resultado
Variable de resultado principal
Change from baseline in Hemoglobin A1c (HbA1c)
Plazo Baseline to Week 40
Variable de resultado secundaria
Achievement of HbA1c < 7% (53 mmol/mol)
Plazo Week 40
Variable de resultado secundaria
Achievement of HbA1c ≤ 6.5% (48 mmol/mol)
Plazo Week 40
Variable de resultado secundaria
Percent change in body weight
Plazo Baseline to Week 40
Variable de resultado secundaria
Change from baseline in body weight
Plazo Baseline to Week 40
Variable de resultado secundaria
Change from baseline in Systolic Blood Pressure (SBP)
Plazo Baseline to Week 40
Variable de resultado secundaria
Achievement of ≥5% weight loss from baseline
Plazo Baseline to Week 40
Variable de resultado secundaria
Change from baseline in Diastolic Blood Pressure (DBP)
Plazo Baseline to Week 40
Variable de resultado secundaria
Time to initiation of rescue medication over 40 weeks
Plazo Baseline to Week 40
Fechas
| Fecha de inicio | 6 de julio de 2026 (real) |
|---|---|
| Finalización principal | 14 de julio de 2028 (estimada) |
| Finalización | 14 de julio de 2028 (estimada) |
| Primera publicación | 23 de junio de 2026 (real) |
| Última actualización | 31 de agosto de 2026 |
| Resultados publicados | No indicado en el registro |
| Estado verificado por última vez | agosto de 2026 |
Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.
Ubicaciones
2 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 | Caba | Aún no recluta | |
| Research Site | Ciudad de Buenos Aires | Aún no recluta | |
| Research Site | Mar del Plata | Aún no recluta | |
| Research Site | San Nicolás | Aún no recluta | |
| Research Site | San Vicente | Aún no recluta | |
| Research Site | Santa Fe | Aún no recluta |
China
| Centro | Ciudad | Estado o región | Estado |
|---|---|---|---|
| Research Site | Baotou | Aún no recluta | |
| Research Site | Binzhou | Aún no recluta | |
| Research Site | Cangzhou | Aún no recluta | |
| Research Site | Changsha | Aún no recluta | |
| Research Site | Chengdu | Aún no recluta | |
| Research Site | Ganzhou | Aún no recluta | |
| Research Site | Haikou | Aún no recluta | |
| Research Site | Hangzhou | Aún no recluta | |
| Research Site | Huangshi | Aún no recluta | |
| Research Site | Huzhou | Aún no recluta | |
| Research Site | Jinan | Aún no recluta | |
| Research Site | Jinzhou | Aún no recluta | |
| Research Site | Lanzhou | Aún no recluta | |
| Research Site | Lianyungang | Aún no recluta | |
| Research Site | Liaocheng | Aún no recluta | |
| Research Site | Liuzhou | Aún no recluta | |
| Research Site | Loudi | Aún no recluta | |
| Research Site | Luoyang | Aún no recluta | |
| Research Site | Luoyang | Aún no recluta | |
| Research Site | Nanchang | Aún no recluta | |
| Research Site | Nanjing | Aún no recluta | |
| Research Site | Nanjing | Aún no recluta | |
| Research Site | Nanyang | Aún no recluta | |
| Research Site | Ningbo | Aún no recluta | |
| Research Site | Panjin | Aún no recluta | |
| Research Site | Qingdao | Aún no recluta | |
| Research Site | Sanmenxia | Aún no recluta | |
| Research Site | Shanghai | Aún no recluta | |
| Research Site | Suining Shi | Aún no recluta | |
| Research Site | Tonghua | Aún no recluta | |
| Research Site | Xi'an | Aún no recluta | |
| Research Site | Xiangtan | Aún no recluta | |
| Research Site | Xuancheng | Aún no recluta | |
| Research Site | Yibin | Aún no recluta | |
| Research Site | Yichang | Aún no recluta | |
| Research Site | Yuncheng | Aún no recluta | |
| Research Site | Zhengzhou | Aún no recluta | |
| Research Site | Zhengzhou | Aún no recluta | |
| Research Site | Zhenjiang | Aún no recluta |
Denmark
| Centro | Ciudad | Estado o región | Estado |
|---|---|---|---|
| Research Site | Gandrup | Aún no recluta | |
| Research Site | Herlev | Aún no recluta | |
| Research Site | Hillerød | Aún no recluta |
En el registro figuran 99 centros más.
Documentos del estudio
No hay documentos enlazados en este registro.
Cambios a lo largo del tiempo
- 31 de agosto de 2026
Centro eliminado
1 site removed (149 total)
150149
- 4 de agosto de 2026
Centro añadido
1 site added (150 total)
149150