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)

RecruitingTaking participants now, according to the registry record.

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In brief

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 sought209 sites15 countries

Registered in 1 registry

ClinicalTrials.govNCT07662213Open this record at ClinicalTrials.govSynced 2 weeks ago

One study can be registered in several registries. We show it once and link every record we hold.

Trial information is shown as published by the registry, in its original language.

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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.

Summary

Conditions

Type 2 Diabetes Mellitus

Eligibility

Eligibility
Sex	All
Ages	18 Years – No maximum
Healthy volunteers	No

Eligibility as written in the registry

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

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study design
Study type	Interventional
Phase	Phase 3
Allocation	Randomised
Intervention model	PARALLEL
Primary purpose	TREATMENT
Masking	NONE (0)
Enrolment	1,200 participants sought

Sponsor and collaborators

AstraZeneca Sponsor

Arms and 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

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

Outcome measures

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

Dates

Dates
Start date	July 6, 2026 (actual)
Primary completion	May 23, 2028 (estimated)
Completion	May 23, 2028 (estimated)
First posted	June 23, 2026 (actual)
Last updated	September 9, 2026
Results posted	Not stated in the registry record
Status last verified	May 2026

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

51 sites are recruiting

Argentina

Argentina
Facility	City	Status
Research Site	Buenos Aires	Not yet recruiting
Research Site	Buenos Aires	Recruiting
Research Site	Caba	Not yet recruiting
Research Site	Ciudad de Buenos Aires	Recruiting
Research Site	Rosario	Not yet recruiting
Research Site	San Nicolás	Not yet recruiting
Research Site	San Vicente	Recruiting

Australia

Australia
Facility	City	Status
Research Site	Botany	Recruiting
Research Site	East Toowoomba	Recruiting
Research Site	Fitzroy	Not yet recruiting
Research Site	Heidelberg Heights	Not yet recruiting
Research Site	Kingswood	Not yet recruiting
Research Site	Melbourne	Recruiting
Research Site	Parkville	Recruiting
Research Site	Penrith	Not yet recruiting
Research Site	St Leonards	Recruiting

Brazil

Brazil
Facility	City	Status
Research Site	Brasília	Not yet recruiting
Research Site	Campinas	Not yet recruiting
Research Site	Curitiba	Not yet recruiting
Research Site	Natal	Not yet recruiting
Research Site	Porto Alegre	Not yet recruiting
Research Site	São José dos Campos	Not yet recruiting
Research Site	São Paulo	Not yet recruiting

Bulgaria

Bulgaria
Facility	City	Status
Research Site	Plovdiv	Recruiting
Research Site	Sofia	Recruiting
Research Site	Sofia	Not yet recruiting
Research Site	Sofia	Not yet recruiting
Research Site	Yambol	Not yet recruiting

Canada

Canada
Facility	City	State or region	Status
Research Site	Guelph	Ontario	Not yet recruiting
Research Site	Montreal	Quebec	Recruiting
Research Site	Saint-Charles-Borromée	Quebec	Recruiting
Research Site	Sarnia	Ontario	Recruiting
Research Site	Scarborough Village	Ontario	Recruiting
Research Site	Stouffville	Ontario	Recruiting
Research Site	Toronto	Ontario	Recruiting
Research Site	Toronto	Ontario	Not yet recruiting
Research Site	Toronto	Ontario	Recruiting
Research Site	Vancouver	British Columbia	Recruiting

China

China
Facility	City	Status
Research Site	Changsha	Not yet recruiting
Research Site	Changsha	Not yet recruiting
Research Site	Hefei	Not yet recruiting
Research Site	Hefei	Not yet recruiting
Research Site	Huai'an	Not yet recruiting
Research Site	Langfang	Not yet recruiting
Research Site	Liangyugang	Not yet recruiting
Research Site	Luoyang	Not yet recruiting
Research Site	Nanjing	Not yet recruiting
Research Site	Nanyang	Not yet recruiting
Research Site	Pinggu	Not yet recruiting
Research Site	Pingxiang	Not yet recruiting

159 further sites are listed in the registry record.

Study documents

No documents are linked in this registry record.

Changes over time

September 9, 2026
Site added
8 sites added (209 total)
201209

Registry: ClinicalTrials.gov · NCT########

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

Categories

Registered in 1 registry

Interested in this study?

How this study is set up

Summary

Conditions

Eligibility

Eligibility as written in the registry

Eligibility in plain statements

Study design

Sponsor and collaborators

Arms and interventions

Interventions

Outcome measures

Dates

Locations

Argentina

Australia

Brazil

Bulgaria

Canada

China

Study documents

Changes over time