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)

RekrutiertNimmt laut Registereintrag derzeit Teilnehmende auf.

Diese Studie kontaktieren

Kurz gefasst

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 Teilnehmende gesucht209 Studienzentren15 Länder

Kategorien

Endokrin und metabolisch68%Herz-Kreislauf32%

In 1 Register registriert

ClinicalTrials.govNCT07662213Diesen Eintrag bei ClinicalTrials.gov öffnenSynchronisiert vor 2 Wochen

Eine Studie kann in mehreren Registern registriert sein. Wir zeigen sie einmal und verlinken jeden Eintrag, den wir haben.

Die Studieninformationen werden so angezeigt, wie sie vom Register veröffentlicht wurden, in ihrer Originalsprache.

Interesse an dieser Studie?

Anmelden oder ein Konto erstellen um Ihr Interesse zu bekunden und diese Studie zu verfolgen.

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.

Zusammenfassung

Erkrankungen

Type 2 Diabetes Mellitus

Eignung

Eignung
Geschlecht	Alle
Alter	18 Years – Kein Höchstalter
Gesunde Freiwillige	Nein

Eignung im Wortlaut des Registers

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

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

Studiendesign
Studientyp	Interventionell
Phase	Phase 3
Zuteilung	Randomisiert
Interventionsmodell	PARALLEL
Primäres Ziel	TREATMENT
Verblindung	NONE (0)
Teilnahme	1.200 Teilnehmende gesucht

Sponsor und Mitwirkende

AstraZeneca Sponsor

Studienarme und Interventionen

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.

Interventionen

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

Endpunkte

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

Daten

Daten
Startdatum	6. Juli 2026 (tatsächlich)
Primärer Abschluss	23. Mai 2028 (geschätzt)
Abschluss	23. Mai 2028 (geschätzt)
Erstveröffentlichung	23. Juni 2026 (tatsächlich)
Zuletzt aktualisiert	9. September 2026
Ergebnisse veröffentlicht	Im Registereintrag nicht angegeben
Status zuletzt bestätigt	Mai 2026

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

51 Studienzentren rekrutieren

Argentina

Argentina
Einrichtung	Stadt	Status
Research Site	Buenos Aires	Rekrutierung noch nicht begonnen
Research Site	Buenos Aires	Rekrutiert
Research Site	Caba	Rekrutierung noch nicht begonnen
Research Site	Ciudad de Buenos Aires	Rekrutiert
Research Site	Rosario	Rekrutierung noch nicht begonnen
Research Site	San Nicolás	Rekrutierung noch nicht begonnen
Research Site	San Vicente	Rekrutiert

Australia

Australia
Einrichtung	Stadt	Status
Research Site	Botany	Rekrutiert
Research Site	East Toowoomba	Rekrutiert
Research Site	Fitzroy	Rekrutierung noch nicht begonnen
Research Site	Heidelberg Heights	Rekrutierung noch nicht begonnen
Research Site	Kingswood	Rekrutierung noch nicht begonnen
Research Site	Melbourne	Rekrutiert
Research Site	Parkville	Rekrutiert
Research Site	Penrith	Rekrutierung noch nicht begonnen
Research Site	St Leonards	Rekrutiert

Brazil

Brazil
Einrichtung	Stadt	Status
Research Site	Brasília	Rekrutierung noch nicht begonnen
Research Site	Campinas	Rekrutierung noch nicht begonnen
Research Site	Curitiba	Rekrutierung noch nicht begonnen
Research Site	Natal	Rekrutierung noch nicht begonnen
Research Site	Porto Alegre	Rekrutierung noch nicht begonnen
Research Site	São José dos Campos	Rekrutierung noch nicht begonnen
Research Site	São Paulo	Rekrutierung noch nicht begonnen

Bulgaria

Bulgaria
Einrichtung	Stadt	Status
Research Site	Plovdiv	Rekrutiert
Research Site	Sofia	Rekrutiert
Research Site	Sofia	Rekrutierung noch nicht begonnen
Research Site	Sofia	Rekrutierung noch nicht begonnen
Research Site	Yambol	Rekrutierung noch nicht begonnen

Canada

Canada
Einrichtung	Stadt	Bundesland oder Region	Status
Research Site	Guelph	Ontario	Rekrutierung noch nicht begonnen
Research Site	Montreal	Quebec	Rekrutiert
Research Site	Saint-Charles-Borromée	Quebec	Rekrutiert
Research Site	Sarnia	Ontario	Rekrutiert
Research Site	Scarborough Village	Ontario	Rekrutiert
Research Site	Stouffville	Ontario	Rekrutiert
Research Site	Toronto	Ontario	Rekrutiert
Research Site	Toronto	Ontario	Rekrutierung noch nicht begonnen
Research Site	Toronto	Ontario	Rekrutiert
Research Site	Vancouver	British Columbia	Rekrutiert

China

China
Einrichtung	Stadt	Status
Research Site	Changsha	Rekrutierung noch nicht begonnen
Research Site	Changsha	Rekrutierung noch nicht begonnen
Research Site	Hefei	Rekrutierung noch nicht begonnen
Research Site	Hefei	Rekrutierung noch nicht begonnen
Research Site	Huai'an	Rekrutierung noch nicht begonnen
Research Site	Langfang	Rekrutierung noch nicht begonnen
Research Site	Liangyugang	Rekrutierung noch nicht begonnen
Research Site	Luoyang	Rekrutierung noch nicht begonnen
Research Site	Nanjing	Rekrutierung noch nicht begonnen
Research Site	Nanyang	Rekrutierung noch nicht begonnen
Research Site	Pinggu	Rekrutierung noch nicht begonnen
Research Site	Pingxiang	Rekrutierung noch nicht begonnen

159 weitere Studienzentren sind im Registereintrag aufgeführt.

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

9. September 2026
Studienzentrum hinzugefügt
8 sites added (209 total)
201209

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