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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)

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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 Teilnehmende gesucht149 Studienzentren13 Länder

Kategorien

Endokrin und metabolisch100%

In 1 Register registriert

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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.

  • Registered before enrolment beganFirst posted 2026-06-23; recorded start 2026-07-06
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are randomly assignedAllocation is recorded as randomised
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Uses blinding (masking)A masking level is recorded in the record
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • 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.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 1019 other studies in this databaseCounted from the lead sponsor named in the record (AstraZeneca)
  • 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.

Zusammenfassung

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 with other background glucose-lowering medication.

Erkrankungen

  • Type 2 Diabetes Mellitus

Eignung

GeschlechtAlle
Alter18 Years – Kein Höchstalter
Gesunde FreiwilligeNein

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 * 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

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

StudientypInterventionell
PhasePhase 3
ZuteilungRandomisiert
InterventionsmodellPARALLEL
Primäres ZielTREATMENT
VerblindungQUADRUPLE (4)
Teilnahme800 Teilnehmende gesucht

Sponsor und Mitwirkende

  • AstraZeneca Sponsor

Studienarme und Interventionen

  • 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.

Interventionen

  • Arzneimittel Dapagliflozin

    Dapagliflozin administered orally once daily.

  • Arzneimittel Dapagliflozin-matched placebo

    A placebo matching dapagliflozin, administered orally once daily.

  • Arzneimittel Elecoglipron

    Elecoglipron is administered orally once daily.

  • Arzneimittel Elecoglipron-matched placebo

    A placebo matching elecoglipron, administered orally once daily.

Endpunkte

  1. Primärer Endpunkt

    Change from baseline in Hemoglobin A1c (HbA1c)

    Zeitrahmen Baseline to Week 40

  2. Sekundärer Endpunkt

    Achievement of HbA1c < 7% (53 mmol/mol)

    Zeitrahmen Week 40

  3. Sekundärer Endpunkt

    Achievement of HbA1c ≤ 6.5% (48 mmol/mol)

    Zeitrahmen Week 40

  4. Sekundärer Endpunkt

    Percent change in body weight

    Zeitrahmen Baseline to Week 40

  5. Sekundärer Endpunkt

    Change from baseline in body weight

    Zeitrahmen Baseline to Week 40

  6. Sekundärer Endpunkt

    Change from baseline in Systolic Blood Pressure (SBP)

    Zeitrahmen Baseline to Week 40

  7. Sekundärer Endpunkt

    Achievement of ≥5% weight loss from baseline

    Zeitrahmen Baseline to Week 40

  8. Sekundärer Endpunkt

    Change from baseline in Diastolic Blood Pressure (DBP)

    Zeitrahmen Baseline to Week 40

  9. Sekundärer Endpunkt

    Time to initiation of rescue medication over 40 weeks

    Zeitrahmen Baseline to Week 40

Daten

Startdatum6. Juli 2026 (tatsächlich)
Primärer Abschluss14. Juli 2028 (geschätzt)
Abschluss14. Juli 2028 (geschätzt)
Erstveröffentlichung23. Juni 2026 (tatsächlich)
Zuletzt aktualisiert31. August 2026
Ergebnisse veröffentlichtIm Registereintrag nicht angegeben
Status zuletzt bestätigtAugust 2026

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

Standorte

2 Studienzentren rekrutieren

Argentina

EinrichtungStadtBundesland oder RegionStatus
Research SiteBuenos AiresRekrutierung noch nicht begonnen
Research SiteCABARekrutierung noch nicht begonnen
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China

EinrichtungStadtBundesland oder RegionStatus
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Denmark

EinrichtungStadtBundesland oder RegionStatus
Research SiteGandrupRekrutierung noch nicht begonnen
Research SiteHerlevRekrutierung noch nicht begonnen
Research SiteHillerødRekrutierung noch nicht begonnen

99 weitere Studienzentren sind im Registereintrag aufgeführt.

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

  1. 31. August 2026

    Studienzentrum entfernt

    1 site removed (149 total)

    150149

  2. 4. August 2026

    Studienzentrum hinzugefügt

    1 site added (150 total)

    149150

Register: ClinicalTrials.gov · NCT########

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