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)

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En resumen

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…

Fase 31200 participantes buscados209 centros15 países

Categorías

Endocrino y metabólico68%Cardiovascular32%

Registrado en 1 registro

ClinicalTrials.govNCT07662213Abrir este registro en ClinicalTrials.govSincronizado hace 2 semanas

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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
Not stated: Open label (no blinding)Masking is recorded as none (open label)
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
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.

Resumen

Afecciones

Type 2 Diabetes Mellitus

Elegibilidad

Elegibilidad
Sexo	Todos
Edades	18 Years – Sin máximo
Voluntarios sanos	No

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(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

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 estudio	De intervención
Fase	Fase 3
Asignación	Aleatorizado
Modelo de intervención	PARALLEL
Propósito principal	TREATMENT
Enmascaramiento	NONE (0)
Inscripción	1200 participantes buscados

Patrocinador y colaboradores

AstraZeneca Patrocinador

Grupos e intervenciones

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.

Intervenciones

Fármaco Elecoglipron
Elecoglipron is administered orally once daily.
Fármaco Semaglutide
Semaglutide is administered orally once daily.

Variables de resultado

Variable de resultado principal
Change from baseline in Hemoglobin A1c (HbA1c)
Plazo Baseline to Week 52
Variable de resultado secundaria
Percent change from baseline to Week 52 in body weight
Plazo Baseline to Week 52
Variable de resultado secundaria
Change from baseline to Week 52 in body weight (kg)
Plazo Baseline to Week 52
Variable de resultado secundaria
Achieved ≥ 5% weight loss from baseline at Week 52 and achieved HbA1c < 7% (53 mmol/mol) at Week 52
Plazo Baseline to Week 52
Variable de resultado secundaria
Achieved HbA1c ≤ 6.5% (48 mmol/mol) at Week 52
Plazo Week 52
Variable de resultado secundaria
Achieved HbA1c < 7% (53 mmol/mol) at Week 52
Plazo Week 52
Variable de resultado secundaria
Achieved ≥ 5% weight loss from baseline at Week 52
Plazo Baseline to Week 52
Variable de resultado secundaria
Change from baseline to Week 52 in Systolic Blood Pressure (BP) and Diastolic BP
Plazo Baseline to Week 52

Fechas

Fechas
Fecha de inicio	6 de julio de 2026 (real)
Finalización principal	23 de mayo de 2028 (estimada)
Finalización	23 de mayo de 2028 (estimada)
Primera publicación	23 de junio de 2026 (real)
Última actualización	9 de septiembre de 2026
Resultados publicados	No indicado en el registro
Estado verificado por última vez	mayo de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

51 centros están en reclutamiento

Argentina

Argentina
Centro	Ciudad	Estado
Research Site	Buenos Aires	Aún no recluta
Research Site	Buenos Aires	En reclutamiento
Research Site	Caba	Aún no recluta
Research Site	Ciudad de Buenos Aires	En reclutamiento
Research Site	Rosario	Aún no recluta
Research Site	San Nicolás	Aún no recluta
Research Site	San Vicente	En reclutamiento

Australia

Australia
Centro	Ciudad	Estado
Research Site	Botany	En reclutamiento
Research Site	East Toowoomba	En reclutamiento
Research Site	Fitzroy	Aún no recluta
Research Site	Heidelberg Heights	Aún no recluta
Research Site	Kingswood	Aún no recluta
Research Site	Melbourne	En reclutamiento
Research Site	Parkville	En reclutamiento
Research Site	Penrith	Aún no recluta
Research Site	St Leonards	En reclutamiento

Brazil

Brazil
Centro	Ciudad	Estado
Research Site	Brasília	Aún no recluta
Research Site	Campinas	Aún no recluta
Research Site	Curitiba	Aún no recluta
Research Site	Natal	Aún no recluta
Research Site	Porto Alegre	Aún no recluta
Research Site	São José dos Campos	Aún no recluta
Research Site	São Paulo	Aún no recluta

Bulgaria

Bulgaria
Centro	Ciudad	Estado
Research Site	Plovdiv	En reclutamiento
Research Site	Sofia	En reclutamiento
Research Site	Sofia	Aún no recluta
Research Site	Sofia	Aún no recluta
Research Site	Yambol	Aún no recluta

Canada

Canada
Centro	Ciudad	Estado o región	Estado
Research Site	Guelph	Ontario	Aún no recluta
Research Site	Montreal	Quebec	En reclutamiento
Research Site	Saint-Charles-Borromée	Quebec	En reclutamiento
Research Site	Sarnia	Ontario	En reclutamiento
Research Site	Scarborough Village	Ontario	En reclutamiento
Research Site	Stouffville	Ontario	En reclutamiento
Research Site	Toronto	Ontario	En reclutamiento
Research Site	Toronto	Ontario	Aún no recluta
Research Site	Toronto	Ontario	En reclutamiento
Research Site	Vancouver	British Columbia	En reclutamiento

China

China
Centro	Ciudad	Estado
Research Site	Changsha	Aún no recluta
Research Site	Changsha	Aún no recluta
Research Site	Hefei	Aún no recluta
Research Site	Hefei	Aún no recluta
Research Site	Huai'an	Aún no recluta
Research Site	Langfang	Aún no recluta
Research Site	Liangyugang	Aún no recluta
Research Site	Luoyang	Aún no recluta
Research Site	Nanjing	Aún no recluta
Research Site	Nanyang	Aún no recluta
Research Site	Pinggu	Aún no recluta
Research Site	Pingxiang	Aún no recluta

En el registro figuran 159 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

9 de septiembre de 2026
Centro añadido
8 sites added (209 total)
201209

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

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