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)

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 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 sought149 sites13 countries

Registered in 1 registry

ClinicalTrials.govNCT07662044Open this record at ClinicalTrials.govSynced 3 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.

Interested in this study?

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.

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 * 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

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	QUADRUPLE (4)
Enrolment	800 participants sought

Sponsor and collaborators

AstraZeneca Sponsor

Arms and 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

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

Outcome measures

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

Dates

Dates
Start date	July 6, 2026 (actual)
Primary completion	July 14, 2028 (estimated)
Completion	July 14, 2028 (estimated)
First posted	June 23, 2026 (actual)
Last updated	August 31, 2026
Results posted	Not stated in the registry record
Status last verified	August 2026

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

Locations

2 sites are recruiting

Argentina

Argentina
Facility	City	Status
Research Site	Buenos Aires	Not yet recruiting
Research Site	CABA	Not yet recruiting
Research Site	Caba	Not yet recruiting
Research Site	Ciudad de Buenos Aires	Not yet recruiting
Research Site	Mar del Plata	Not yet recruiting
Research Site	San Nicolás	Not yet recruiting
Research Site	San Vicente	Not yet recruiting
Research Site	Santa Fe	Not yet recruiting

China

China
Facility	City	Status
Research Site	Baotou	Not yet recruiting
Research Site	Binzhou	Not yet recruiting
Research Site	Cangzhou	Not yet recruiting
Research Site	Changsha	Not yet recruiting
Research Site	Chengdu	Not yet recruiting
Research Site	Ganzhou	Not yet recruiting
Research Site	Haikou	Not yet recruiting
Research Site	Hangzhou	Not yet recruiting
Research Site	Huangshi	Not yet recruiting
Research Site	Huzhou	Not yet recruiting
Research Site	Jinan	Not yet recruiting
Research Site	Jinzhou	Not yet recruiting
Research Site	Lanzhou	Not yet recruiting
Research Site	Lianyungang	Not yet recruiting
Research Site	Liaocheng	Not yet recruiting
Research Site	Liuzhou	Not yet recruiting
Research Site	Loudi	Not yet recruiting
Research Site	Luoyang	Not yet recruiting
Research Site	Luoyang	Not yet recruiting
Research Site	Nanchang	Not yet recruiting
Research Site	Nanjing	Not yet recruiting
Research Site	Nanjing	Not yet recruiting
Research Site	Nanyang	Not yet recruiting
Research Site	Ningbo	Not yet recruiting
Research Site	Panjin	Not yet recruiting
Research Site	Qingdao	Not yet recruiting
Research Site	Sanmenxia	Not yet recruiting
Research Site	Shanghai	Not yet recruiting
Research Site	Suining Shi	Not yet recruiting
Research Site	Tonghua	Not yet recruiting
Research Site	Xi'an	Not yet recruiting
Research Site	Xiangtan	Not yet recruiting
Research Site	Xuancheng	Not yet recruiting
Research Site	Yibin	Not yet recruiting
Research Site	Yichang	Not yet recruiting
Research Site	Yuncheng	Not yet recruiting
Research Site	Zhengzhou	Not yet recruiting
Research Site	Zhengzhou	Not yet recruiting
Research Site	Zhenjiang	Not yet recruiting

Denmark

Denmark
Facility	City	Status
Research Site	Gandrup	Not yet recruiting
Research Site	Herlev	Not yet recruiting
Research Site	Hillerød	Not yet recruiting

99 further sites are listed in the registry record.

Study documents

No documents are linked in this registry record.

Changes over time

August 31, 2026
Site removed
1 site removed (149 total)
150149
August 4, 2026
Site added
1 site added (150 total)
149150

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

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

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

China

Denmark

Study documents

Changes over time