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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)

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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

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La información del ensayo se muestra tal como la publicó el registro, en su idioma original.

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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.

Methodological rigourSTRONG

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

ScaleLARGE

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

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.

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

Elegibilidad
SexoTodos
Edades18 YearsSin máximo
Voluntarios sanosNo

Elegibilidad tal como figura en el registro

Inclusion Criteria: * Diagnosed with Type 2 Diabetes Mellitus (T2DM) for at least 90 days prior to screening * T2DM inadequately managed with lifestyle management alone or on stable treatment with other background glucose-lowering medication * HbA1c value of ≥ 7% to ≤ 10.5% (53 to 91.3 mmol/mol) * Body mass index (BMI) of ≥ 23 kg/m2 at screening * Stable body weight (self-reported or documented) for 90 days prior to screening Exclusion Criteria: * Type 1 diabetes, secondary forms of diabetes (including congenital forms), or history of ketoacidosis or hyperosmolar coma * Currently receiving or anticipated to receive, therapeutic intervention for diabetic retinopathy and/or macular edema * Have had more than one episode of severe hypoglycemia within 180 days prior to screening or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms * Clinically significant condition affecting the upper GI tract or chronic use of any medication that affects gastric motility or gastric emptying * History of acute or chronic pancreatitis * Severe congestive heart failure (New York Heart Association IV) * History/family history of medullary thyroid cancer or multiple endocrine neoplasia type 2

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

Diseño del estudio
Tipo de estudioDe intervención
FaseFase 3
AsignaciónAleatorizado
Modelo de intervenciónPARALLEL
Propósito principalTREATMENT
EnmascaramientoQUADRUPLE (4)
Inscripción800 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

  1. Variable de resultado principal

    Change from baseline in Hemoglobin A1c (HbA1c)

    Plazo Baseline to Week 40

  2. Variable de resultado secundaria

    Achievement of HbA1c < 7% (53 mmol/mol)

    Plazo Week 40

  3. Variable de resultado secundaria

    Achievement of HbA1c ≤ 6.5% (48 mmol/mol)

    Plazo Week 40

  4. Variable de resultado secundaria

    Percent change in body weight

    Plazo Baseline to Week 40

  5. Variable de resultado secundaria

    Change from baseline in body weight

    Plazo Baseline to Week 40

  6. Variable de resultado secundaria

    Change from baseline in Systolic Blood Pressure (SBP)

    Plazo Baseline to Week 40

  7. Variable de resultado secundaria

    Achievement of ≥5% weight loss from baseline

    Plazo Baseline to Week 40

  8. Variable de resultado secundaria

    Change from baseline in Diastolic Blood Pressure (DBP)

    Plazo Baseline to Week 40

  9. Variable de resultado secundaria

    Time to initiation of rescue medication over 40 weeks

    Plazo Baseline to Week 40

Fechas

Fechas
Fecha de inicio6 de julio de 2026 (real)
Finalización principal14 de julio de 2028 (estimada)
Finalización14 de julio de 2028 (estimada)
Primera publicación23 de junio de 2026 (real)
Última actualización31 de agosto de 2026
Resultados publicadosNo indicado en el registro
Estado verificado por última vezagosto 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

Argentina
CentroCiudadEstado o regiónEstado
Research SiteBuenos AiresAún no recluta
Research SiteCABAAún no recluta
Research SiteCabaAún no recluta
Research SiteCiudad de Buenos AiresAún no recluta
Research SiteMar del PlataAún no recluta
Research SiteSan NicolásAún no recluta
Research SiteSan VicenteAún no recluta
Research SiteSanta FeAún no recluta

China

China
CentroCiudadEstado o regiónEstado
Research SiteBaotouAún no recluta
Research SiteBinzhouAún no recluta
Research SiteCangzhouAún no recluta
Research SiteChangshaAún no recluta
Research SiteChengduAún no recluta
Research SiteGanzhouAún no recluta
Research SiteHaikouAún no recluta
Research SiteHangzhouAún no recluta
Research SiteHuangshiAún no recluta
Research SiteHuzhouAún no recluta
Research SiteJinanAún no recluta
Research SiteJinzhouAún no recluta
Research SiteLanzhouAún no recluta
Research SiteLianyungangAún no recluta
Research SiteLiaochengAún no recluta
Research SiteLiuzhouAún no recluta
Research SiteLoudiAún no recluta
Research SiteLuoyangAún no recluta
Research SiteLuoyangAún no recluta
Research SiteNanchangAún no recluta
Research SiteNanjingAún no recluta
Research SiteNanjingAún no recluta
Research SiteNanyangAún no recluta
Research SiteNingboAún no recluta
Research SitePanjinAún no recluta
Research SiteQingdaoAún no recluta
Research SiteSanmenxiaAún no recluta
Research SiteShanghaiAún no recluta
Research SiteSuining ShiAún no recluta
Research SiteTonghuaAún no recluta
Research SiteXi'anAún no recluta
Research SiteXiangtanAún no recluta
Research SiteXuanchengAún no recluta
Research SiteYibinAún no recluta
Research SiteYichangAún no recluta
Research SiteYunchengAún no recluta
Research SiteZhengzhouAún no recluta
Research SiteZhengzhouAún no recluta
Research SiteZhenjiangAún no recluta

Denmark

Denmark
CentroCiudadEstado o regiónEstado
Research SiteGandrupAún no recluta
Research SiteHerlevAún no recluta
Research SiteHillerødAún 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

  1. 31 de agosto de 2026

    Centro eliminado

    1 site removed (149 total)

    150149

  2. 4 de agosto de 2026

    Centro añadido

    1 site added (150 total)

    149150