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 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
- ClinicalTrials.govNCT07662044Ouvrir cette fiche sur ClinicalTrials.govSynchronisé il y a 3 semaines
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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.
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
| Sexe | Tous |
|---|---|
| Âges | 18 Years – Aucun maximum |
| Volontaires sains | Non |
Éligibilité telle qu'elle figure dans le registre
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'étude | Interventionnelle |
|---|---|
| Phase | Phase 3 |
| Répartition | Randomisée |
| Modèle d'intervention | PARALLEL |
| Objectif principal | TREATMENT |
| Insu | QUADRUPLE (4) |
| Recrutement | 800 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
Critère de jugement principal
Change from baseline in Hemoglobin A1c (HbA1c)
Délai Baseline to Week 40
Critère de jugement secondaire
Achievement of HbA1c < 7% (53 mmol/mol)
Délai Week 40
Critère de jugement secondaire
Achievement of HbA1c ≤ 6.5% (48 mmol/mol)
Délai Week 40
Critère de jugement secondaire
Percent change in body weight
Délai Baseline to Week 40
Critère de jugement secondaire
Change from baseline in body weight
Délai Baseline to Week 40
Critère de jugement secondaire
Change from baseline in Systolic Blood Pressure (SBP)
Délai Baseline to Week 40
Critère de jugement secondaire
Achievement of ≥5% weight loss from baseline
Délai Baseline to Week 40
Critère de jugement secondaire
Change from baseline in Diastolic Blood Pressure (DBP)
Délai Baseline to Week 40
Critère de jugement secondaire
Time to initiation of rescue medication over 40 weeks
Délai Baseline to Week 40
Dates
| Date de début | 6 juillet 2026 (réelle) |
|---|---|
| Achèvement principal | 14 juillet 2028 (estimée) |
| Achèvement | 14 juillet 2028 (estimée) |
| Première publication | 23 juin 2026 (réelle) |
| Dernière mise à jour | 31 août 2026 |
| Résultats publiés | Non précisé dans la fiche du registre |
| Statut vérifié pour la dernière fois | août 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
| Établissement | Ville | État ou région | Statut |
|---|---|---|---|
| Research Site | Buenos Aires | Pas encore en recrutement | |
| Research Site | CABA | Pas encore en recrutement | |
| Research Site | Caba | Pas encore en recrutement | |
| Research Site | Ciudad de Buenos Aires | Pas encore en recrutement | |
| Research Site | Mar del Plata | Pas encore en recrutement | |
| Research Site | San Nicolás | Pas encore en recrutement | |
| Research Site | San Vicente | Pas encore en recrutement | |
| Research Site | Santa Fe | Pas encore en recrutement |
China
| Établissement | Ville | État ou région | Statut |
|---|---|---|---|
| Research Site | Baotou | Pas encore en recrutement | |
| Research Site | Binzhou | Pas encore en recrutement | |
| Research Site | Cangzhou | Pas encore en recrutement | |
| Research Site | Changsha | Pas encore en recrutement | |
| Research Site | Chengdu | Pas encore en recrutement | |
| Research Site | Ganzhou | Pas encore en recrutement | |
| Research Site | Haikou | Pas encore en recrutement | |
| Research Site | Hangzhou | Pas encore en recrutement | |
| Research Site | Huangshi | Pas encore en recrutement | |
| Research Site | Huzhou | Pas encore en recrutement | |
| Research Site | Jinan | Pas encore en recrutement | |
| Research Site | Jinzhou | Pas encore en recrutement | |
| Research Site | Lanzhou | Pas encore en recrutement | |
| Research Site | Lianyungang | Pas encore en recrutement | |
| Research Site | Liaocheng | Pas encore en recrutement | |
| Research Site | Liuzhou | Pas encore en recrutement | |
| Research Site | Loudi | Pas encore en recrutement | |
| Research Site | Luoyang | Pas encore en recrutement | |
| Research Site | Luoyang | Pas encore en recrutement | |
| Research Site | Nanchang | Pas encore en recrutement | |
| Research Site | Nanjing | Pas encore en recrutement | |
| Research Site | Nanjing | Pas encore en recrutement | |
| Research Site | Nanyang | Pas encore en recrutement | |
| Research Site | Ningbo | Pas encore en recrutement | |
| Research Site | Panjin | Pas encore en recrutement | |
| Research Site | Qingdao | Pas encore en recrutement | |
| Research Site | Sanmenxia | Pas encore en recrutement | |
| Research Site | Shanghai | Pas encore en recrutement | |
| Research Site | Suining Shi | Pas encore en recrutement | |
| Research Site | Tonghua | Pas encore en recrutement | |
| Research Site | Xi'an | Pas encore en recrutement | |
| Research Site | Xiangtan | Pas encore en recrutement | |
| Research Site | Xuancheng | Pas encore en recrutement | |
| Research Site | Yibin | Pas encore en recrutement | |
| Research Site | Yichang | Pas encore en recrutement | |
| Research Site | Yuncheng | Pas encore en recrutement | |
| Research Site | Zhengzhou | Pas encore en recrutement | |
| Research Site | Zhengzhou | Pas encore en recrutement | |
| Research Site | Zhenjiang | Pas encore en recrutement |
Denmark
| Établissement | Ville | État ou région | Statut |
|---|---|---|---|
| Research Site | Gandrup | Pas encore en recrutement | |
| Research Site | Herlev | Pas encore en recrutement | |
| Research Site | Hillerød | Pas 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
- 31 août 2026
Site retiré
1 site removed (149 total)
150149
- 4 août 2026
Site ajouté
1 site added (150 total)
149150