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NCT07662213ClinicalTrials.gov

A Study to Find Out if the Study Drug Elecoglipron Helps Adults With Type 2 Diabetes Mellitus by Comparing it With Semaglutide, a Medicine Already Used to Treat Type 2 Diabetes Mellitus

A Randomized, Open-label, Parallel-group Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Elecoglipron Compared With Oral Semaglutide in Adults With Type 2 Diabetes Mellitus (Eluminate-2)

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 compared with oral semaglutide in adults with T2DM and increased cardiovascular risk that is inadequately managed alone or on stable treatment with other background glucose-lowering…

Phase 31 200 participants recherchés209 sites15 pays

Catégories

Endocrinien et métabolique68%Cardiovasculaire32%

Enregistré dans 1 registre

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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.

  • Registered before enrolment beganFirst posted 2026-06-23; recorded start 2026-07-06
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are randomly assignedAllocation is recorded as randomised
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Open label (no blinding)Masking is recorded as none (open label)
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • 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.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 1019 other studies in this databaseCounted from the lead sponsor named in the record (AstraZeneca)
  • 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.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

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

  • Blinding0/20

    Open-label

  • Control arm15/15

    Active-comparator 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: 201 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: 1,200 participants (target), run at 209 sites, across 15 countries.

How this score is built
  • Enrolment31/40

    1,200 participants (target)

  • Site count25/25

    201 sites

  • Country count12/15

    15 countries

  • Planned duration7/10

    Planned over about 23 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 compared with oral semaglutide in adults with T2DM and increased cardiovascular risk that is inadequately managed alone or on stable treatment with other background glucose-lowering medication(s).

Affections

  • Type 2 Diabetes Mellitus

Éligibilité

SexeTous
Âges18 Years – Aucun 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(s) * HbA1c value of ≥ 7% to ≤ 10.5% (53 to 91.3 mmol/mol) * Increased risk of cardiovascular (CV) events defined by ≥1 of: documented coronary heart disease, peripheral arterial disease, ischemic cerebrovascular disease, or heart failure (NYHA II-III); or ≥2 CV risk factors * 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 Mellitus (T1DM), 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 Gastrointestinal (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 (NYHA 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

Type d'étudeInterventionnelle
PhasePhase 3
RépartitionRandomisée
Modèle d'interventionPARALLEL
Objectif principalTREATMENT
InsuNONE (0)
Recrutement1 200 participants recherchés

Promoteur et collaborateurs

  • AstraZeneca Promoteur

Groupes et interventions

  • ElecoglipronEXPERIMENTAL

    Participants will receive elecoglipron dose XX mg administered orally once daily.

  • SemaglutideACTIVE_COMPARATOR

    Participants will receive semaglutide dose XX mg administered orally once daily.

Interventions

  • Médicament Elecoglipron

    Elecoglipron is administered orally once daily.

  • Médicament Semaglutide

    Semaglutide is administered orally once daily.

Critères de jugement

  1. Critère de jugement principal

    Change from baseline in Hemoglobin A1c (HbA1c)

    Délai Baseline to Week 52

  2. Critère de jugement secondaire

    Percent change from baseline to Week 52 in body weight

    Délai Baseline to Week 52

  3. Critère de jugement secondaire

    Change from baseline to Week 52 in body weight (kg)

    Délai Baseline to Week 52

  4. Critère de jugement secondaire

    Achieved ≥ 5% weight loss from baseline at Week 52 and achieved HbA1c < 7% (53 mmol/mol) at Week 52

    Délai Baseline to Week 52

  5. Critère de jugement secondaire

    Achieved HbA1c ≤ 6.5% (48 mmol/mol) at Week 52

    Délai Week 52

  6. Critère de jugement secondaire

    Achieved HbA1c < 7% (53 mmol/mol) at Week 52

    Délai Week 52

  7. Critère de jugement secondaire

    Achieved ≥ 5% weight loss from baseline at Week 52

    Délai Baseline to Week 52

  8. Critère de jugement secondaire

    Change from baseline to Week 52 in Systolic Blood Pressure (BP) and Diastolic BP

    Délai Baseline to Week 52

Dates

Date de début6 juillet 2026 (réelle)
Achèvement principal23 mai 2028 (estimée)
Achèvement23 mai 2028 (estimée)
Première publication23 juin 2026 (réelle)
Dernière mise à jour9 septembre 2026
Résultats publiésNon précisé dans la fiche du registre
Statut vérifié pour la dernière foismai 2026

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

Lieux

51 sites sont en recrutement

Argentina

ÉtablissementVilleÉtat ou régionStatut
Research SiteBuenos AiresPas encore en recrutement
Research SiteBuenos AiresEn recrutement
Research SiteCabaPas encore en recrutement
Research SiteCiudad de Buenos AiresEn recrutement
Research SiteRosarioPas encore en recrutement
Research SiteSan NicolásPas encore en recrutement
Research SiteSan VicenteEn recrutement

Australia

ÉtablissementVilleÉtat ou régionStatut
Research SiteBotanyEn recrutement
Research SiteEast ToowoombaEn recrutement
Research SiteFitzroyPas encore en recrutement
Research SiteHeidelberg HeightsPas encore en recrutement
Research SiteKingswoodPas encore en recrutement
Research SiteMelbourneEn recrutement
Research SiteParkvilleEn recrutement
Research SitePenrithPas encore en recrutement
Research SiteSt LeonardsEn recrutement

Brazil

ÉtablissementVilleÉtat ou régionStatut
Research SiteBrasíliaPas encore en recrutement
Research SiteCampinasPas encore en recrutement
Research SiteCuritibaPas encore en recrutement
Research SiteNatalPas encore en recrutement
Research SitePorto AlegrePas encore en recrutement
Research SiteSão José dos CamposPas encore en recrutement
Research SiteSão PauloPas encore en recrutement

Bulgaria

ÉtablissementVilleÉtat ou régionStatut
Research SitePlovdivEn recrutement
Research SiteSofiaEn recrutement
Research SiteSofiaPas encore en recrutement
Research SiteSofiaPas encore en recrutement
Research SiteYambolPas encore en recrutement

Canada

ÉtablissementVilleÉtat ou régionStatut
Research SiteGuelphOntarioPas encore en recrutement
Research SiteMontrealQuebecEn recrutement
Research SiteSaint-Charles-BorroméeQuebecEn recrutement
Research SiteSarniaOntarioEn recrutement
Research SiteScarborough VillageOntarioEn recrutement
Research SiteStouffvilleOntarioEn recrutement
Research SiteTorontoOntarioEn recrutement
Research SiteTorontoOntarioPas encore en recrutement
Research SiteTorontoOntarioEn recrutement
Research SiteVancouverBritish ColumbiaEn recrutement

China

ÉtablissementVilleÉtat ou régionStatut
Research SiteChangshaPas encore en recrutement
Research SiteChangshaPas encore en recrutement
Research SiteHefeiPas encore en recrutement
Research SiteHefeiPas encore en recrutement
Research SiteHuai'anPas encore en recrutement
Research SiteLangfangPas encore en recrutement
Research SiteLiangyugangPas encore en recrutement
Research SiteLuoyangPas encore en recrutement
Research SiteNanjingPas encore en recrutement
Research SiteNanyangPas encore en recrutement
Research SitePingguPas encore en recrutement
Research SitePingxiangPas encore en recrutement

159 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. 9 septembre 2026

    Site ajouté

    8 sites added (209 total)

    201209

Registre: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT07662213