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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)

En recrutementAccepte des participants actuellement, selon la fiche du registre.
Contacter cette étude

En bref

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…

Phase 3800 participants recherchés149 sites13 pays

Catégories

Enregistré dans 1 registre

Une même étude peut être enregistrée dans plusieurs registres. Nous l'affichons une seule fois et renvoyons vers chaque fiche que nous détenons.

Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

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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.

Résumé

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.

Affections

  • Type 2 Diabetes Mellitus

Éligibilité

Éligibilité
SexeTous
Âges18 YearsAucun maximum
Volontaires sainsNon

Éligibilité telle qu'elle figure dans le registre

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

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

Conception de l'étude
Type d'étudeInterventionnelle
PhasePhase 3
RépartitionRandomisée
Modèle d'interventionPARALLEL
Objectif principalTREATMENT
InsuQUADRUPLE (4)
Recrutement800 participants recherchés

Promoteur et collaborateurs

  • AstraZeneca Promoteur

Groupes et interventions

  • 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.

Interventions

  • Médicament Dapagliflozin

    Dapagliflozin administered orally once daily.

  • Médicament Dapagliflozin-matched placebo

    A placebo matching dapagliflozin, administered orally once daily.

  • Médicament Elecoglipron

    Elecoglipron is administered orally once daily.

  • Médicament Elecoglipron-matched placebo

    A placebo matching elecoglipron, administered orally once daily.

Critères de jugement

  1. Critère de jugement principal

    Change from baseline in Hemoglobin A1c (HbA1c)

    Délai Baseline to Week 40

  2. Critère de jugement secondaire

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

    Délai Week 40

  3. Critère de jugement secondaire

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

    Délai Week 40

  4. Critère de jugement secondaire

    Percent change in body weight

    Délai Baseline to Week 40

  5. Critère de jugement secondaire

    Change from baseline in body weight

    Délai Baseline to Week 40

  6. Critère de jugement secondaire

    Change from baseline in Systolic Blood Pressure (SBP)

    Délai Baseline to Week 40

  7. Critère de jugement secondaire

    Achievement of ≥5% weight loss from baseline

    Délai Baseline to Week 40

  8. Critère de jugement secondaire

    Change from baseline in Diastolic Blood Pressure (DBP)

    Délai Baseline to Week 40

  9. Critère de jugement secondaire

    Time to initiation of rescue medication over 40 weeks

    Délai Baseline to Week 40

Dates

Dates
Date de début6 juillet 2026 (réelle)
Achèvement principal14 juillet 2028 (estimée)
Achèvement14 juillet 2028 (estimée)
Première publication23 juin 2026 (réelle)
Dernière mise à jour31 août 2026
Résultats publiésNon précisé dans la fiche du registre
Statut vérifié pour la dernière foisaoût 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

2 sites sont en recrutement

Argentina

Argentina
ÉtablissementVilleÉtat ou régionStatut
Research SiteBuenos AiresPas encore en recrutement
Research SiteCABAPas encore en recrutement
Research SiteCabaPas encore en recrutement
Research SiteCiudad de Buenos AiresPas encore en recrutement
Research SiteMar del PlataPas encore en recrutement
Research SiteSan NicolásPas encore en recrutement
Research SiteSan VicentePas encore en recrutement
Research SiteSanta FePas encore en recrutement

China

China
ÉtablissementVilleÉtat ou régionStatut
Research SiteBaotouPas encore en recrutement
Research SiteBinzhouPas encore en recrutement
Research SiteCangzhouPas encore en recrutement
Research SiteChangshaPas encore en recrutement
Research SiteChengduPas encore en recrutement
Research SiteGanzhouPas encore en recrutement
Research SiteHaikouPas encore en recrutement
Research SiteHangzhouPas encore en recrutement
Research SiteHuangshiPas encore en recrutement
Research SiteHuzhouPas encore en recrutement
Research SiteJinanPas encore en recrutement
Research SiteJinzhouPas encore en recrutement
Research SiteLanzhouPas encore en recrutement
Research SiteLianyungangPas encore en recrutement
Research SiteLiaochengPas encore en recrutement
Research SiteLiuzhouPas encore en recrutement
Research SiteLoudiPas encore en recrutement
Research SiteLuoyangPas encore en recrutement
Research SiteLuoyangPas encore en recrutement
Research SiteNanchangPas encore en recrutement
Research SiteNanjingPas encore en recrutement
Research SiteNanjingPas encore en recrutement
Research SiteNanyangPas encore en recrutement
Research SiteNingboPas encore en recrutement
Research SitePanjinPas encore en recrutement
Research SiteQingdaoPas encore en recrutement
Research SiteSanmenxiaPas encore en recrutement
Research SiteShanghaiPas encore en recrutement
Research SiteSuining ShiPas encore en recrutement
Research SiteTonghuaPas encore en recrutement
Research SiteXi'anPas encore en recrutement
Research SiteXiangtanPas encore en recrutement
Research SiteXuanchengPas encore en recrutement
Research SiteYibinPas encore en recrutement
Research SiteYichangPas encore en recrutement
Research SiteYunchengPas encore en recrutement
Research SiteZhengzhouPas encore en recrutement
Research SiteZhengzhouPas encore en recrutement
Research SiteZhenjiangPas encore en recrutement

Denmark

Denmark
ÉtablissementVilleÉtat ou régionStatut
Research SiteGandrupPas encore en recrutement
Research SiteHerlevPas encore en recrutement
Research SiteHillerødPas encore en recrutement

99 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

  1. 31 août 2026

    Site retiré

    1 site removed (149 total)

    150149

  2. 4 août 2026

    Site ajouté

    1 site added (150 total)

    149150