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)

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.

Contatta questo studio

In breve

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 partecipanti ricercati149 centri13 paesi

Categorie

Endocrino e metabolico100%

Registrato in 1 registro

ClinicalTrials.govNCT07662044Apri questa scheda su ClinicalTrials.govSincronizzato 3 settimane fa

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Le informazioni sulla sperimentazione sono mostrate così come pubblicate dal registro, nella lingua originale.

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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.

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
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.

Sintesi

Patologie

Type 2 Diabetes Mellitus

Idoneità

Idoneità
Sesso	Tutti
Età	18 Years – Nessun massimo
Volontari sani	No

Idoneità come riportata nel 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

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Disegno dello studio
Tipo di studio	Interventistico
Fase	Fase 3
Assegnazione	Randomizzata
Modello di intervento	PARALLEL
Finalità principale	TREATMENT
Mascheramento	QUADRUPLE (4)
Arruolamento	800 partecipanti ricercati

Sponsor e collaboratori

AstraZeneca Sponsor

Bracci e interventi

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.

Interventi

Farmaco Dapagliflozin
Dapagliflozin administered orally once daily.
Farmaco Dapagliflozin-matched placebo
A placebo matching dapagliflozin, administered orally once daily.
Farmaco Elecoglipron
Elecoglipron is administered orally once daily.
Farmaco Elecoglipron-matched placebo
A placebo matching elecoglipron, administered orally once daily.

Esiti misurati

Esito primario
Change from baseline in Hemoglobin A1c (HbA1c)
Orizzonte temporale Baseline to Week 40
Esito secondario
Achievement of HbA1c < 7% (53 mmol/mol)
Orizzonte temporale Week 40
Esito secondario
Achievement of HbA1c ≤ 6.5% (48 mmol/mol)
Orizzonte temporale Week 40
Esito secondario
Percent change in body weight
Orizzonte temporale Baseline to Week 40
Esito secondario
Change from baseline in body weight
Orizzonte temporale Baseline to Week 40
Esito secondario
Change from baseline in Systolic Blood Pressure (SBP)
Orizzonte temporale Baseline to Week 40
Esito secondario
Achievement of ≥5% weight loss from baseline
Orizzonte temporale Baseline to Week 40
Esito secondario
Change from baseline in Diastolic Blood Pressure (DBP)
Orizzonte temporale Baseline to Week 40
Esito secondario
Time to initiation of rescue medication over 40 weeks
Orizzonte temporale Baseline to Week 40

Date

Date
Data di inizio	6 luglio 2026 (effettiva)
Conclusione primaria	14 luglio 2028 (stimata)
Conclusione	14 luglio 2028 (stimata)
Prima pubblicazione	23 giugno 2026 (effettiva)
Ultimo aggiornamento	31 agosto 2026
Risultati pubblicati	Non indicato nella scheda del registro
Stato verificato l'ultima volta	agosto 2026

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

2 centri stanno reclutando

Argentina

Argentina
Struttura	Città	Stato
Research Site	Buenos Aires	Non ancora in reclutamento
Research Site	CABA	Non ancora in reclutamento
Research Site	Caba	Non ancora in reclutamento
Research Site	Ciudad de Buenos Aires	Non ancora in reclutamento
Research Site	Mar del Plata	Non ancora in reclutamento
Research Site	San Nicolás	Non ancora in reclutamento
Research Site	San Vicente	Non ancora in reclutamento
Research Site	Santa Fe	Non ancora in reclutamento

China

China
Struttura	Città	Stato
Research Site	Baotou	Non ancora in reclutamento
Research Site	Binzhou	Non ancora in reclutamento
Research Site	Cangzhou	Non ancora in reclutamento
Research Site	Changsha	Non ancora in reclutamento
Research Site	Chengdu	Non ancora in reclutamento
Research Site	Ganzhou	Non ancora in reclutamento
Research Site	Haikou	Non ancora in reclutamento
Research Site	Hangzhou	Non ancora in reclutamento
Research Site	Huangshi	Non ancora in reclutamento
Research Site	Huzhou	Non ancora in reclutamento
Research Site	Jinan	Non ancora in reclutamento
Research Site	Jinzhou	Non ancora in reclutamento
Research Site	Lanzhou	Non ancora in reclutamento
Research Site	Lianyungang	Non ancora in reclutamento
Research Site	Liaocheng	Non ancora in reclutamento
Research Site	Liuzhou	Non ancora in reclutamento
Research Site	Loudi	Non ancora in reclutamento
Research Site	Luoyang	Non ancora in reclutamento
Research Site	Luoyang	Non ancora in reclutamento
Research Site	Nanchang	Non ancora in reclutamento
Research Site	Nanjing	Non ancora in reclutamento
Research Site	Nanjing	Non ancora in reclutamento
Research Site	Nanyang	Non ancora in reclutamento
Research Site	Ningbo	Non ancora in reclutamento
Research Site	Panjin	Non ancora in reclutamento
Research Site	Qingdao	Non ancora in reclutamento
Research Site	Sanmenxia	Non ancora in reclutamento
Research Site	Shanghai	Non ancora in reclutamento
Research Site	Suining Shi	Non ancora in reclutamento
Research Site	Tonghua	Non ancora in reclutamento
Research Site	Xi'an	Non ancora in reclutamento
Research Site	Xiangtan	Non ancora in reclutamento
Research Site	Xuancheng	Non ancora in reclutamento
Research Site	Yibin	Non ancora in reclutamento
Research Site	Yichang	Non ancora in reclutamento
Research Site	Yuncheng	Non ancora in reclutamento
Research Site	Zhengzhou	Non ancora in reclutamento
Research Site	Zhengzhou	Non ancora in reclutamento
Research Site	Zhenjiang	Non ancora in reclutamento

Denmark

Denmark
Struttura	Città	Stato
Research Site	Gandrup	Non ancora in reclutamento
Research Site	Herlev	Non ancora in reclutamento
Research Site	Hillerød	Non ancora in reclutamento

Nella scheda del registro sono indicati altri 99 centri.

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

31 agosto 2026
Centro rimosso
1 site removed (149 total)
150149
4 agosto 2026
Centro aggiunto
1 site added (150 total)
149150

Registro: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT07662044