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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)

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.
التواصل مع هذه الدراسة

باختصار

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…

المرحلة 3مطلوب 800 مشارك149 موقعاً13 دولة

الفئات

مسجَّلة في سجل واحد

يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.

تُعرض معلومات التجربة كما نشرها السجل، بلغتها الأصلية.

هل أنت مهتم بهذه الدراسة؟

تسجيل الدخول أو أنشئ حسابًا لتسجيل اهتمامك ومتابعة هذه الدراسة.

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.

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.

ملخص

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.

الحالات

  • Type 2 Diabetes Mellitus

الأهلية

الأهلية
الجنسالجميع
الأعمار18 Yearsلا حد أقصى
المتطوعون الأصحّاءلا

الأهلية كما كُتبت في السجل

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

الأهلية في عبارات بسيطة

لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.

تصميم الدراسة

تصميم الدراسة
نوع الدراسةتدخّلية
المرحلةالمرحلة 3
التخصيصمعشّاة
نموذج التدخّلPARALLEL
الغرض الأساسيTREATMENT
التعميةQUADRUPLE (4)
التجنيدمطلوب 800 مشارك

الجهة الراعية والمتعاونون

  • AstraZeneca الجهة الراعية

الأذرع والتدخلات

  • 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.

التدخلات

  • دواء Dapagliflozin

    Dapagliflozin administered orally once daily.

  • دواء Dapagliflozin-matched placebo

    A placebo matching dapagliflozin, administered orally once daily.

  • دواء Elecoglipron

    Elecoglipron is administered orally once daily.

  • دواء Elecoglipron-matched placebo

    A placebo matching elecoglipron, administered orally once daily.

مقاييس النتائج

  1. مقياس النتيجة الأولي

    Change from baseline in Hemoglobin A1c (HbA1c)

    الإطار الزمني Baseline to Week 40

  2. مقياس النتيجة الثانوي

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

    الإطار الزمني Week 40

  3. مقياس النتيجة الثانوي

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

    الإطار الزمني Week 40

  4. مقياس النتيجة الثانوي

    Percent change in body weight

    الإطار الزمني Baseline to Week 40

  5. مقياس النتيجة الثانوي

    Change from baseline in body weight

    الإطار الزمني Baseline to Week 40

  6. مقياس النتيجة الثانوي

    Change from baseline in Systolic Blood Pressure (SBP)

    الإطار الزمني Baseline to Week 40

  7. مقياس النتيجة الثانوي

    Achievement of ≥5% weight loss from baseline

    الإطار الزمني Baseline to Week 40

  8. مقياس النتيجة الثانوي

    Change from baseline in Diastolic Blood Pressure (DBP)

    الإطار الزمني Baseline to Week 40

  9. مقياس النتيجة الثانوي

    Time to initiation of rescue medication over 40 weeks

    الإطار الزمني Baseline to Week 40

التواريخ

التواريخ
تاريخ البدء6 يوليو 2026 (فعلي)
الإتمام الأولي14 يوليو 2028 (تقديري)
الإتمام14 يوليو 2028 (تقديري)
أول نشر23 يونيو 2026 (فعلي)
آخر تحديث31 أغسطس 2026
النتائج منشورةغير مذكور في سجل السجل
آخر تأكيد للحالةأغسطس 2026

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

موقعان قيد التجنيد

Argentina

Argentina
المنشأةالمدينةالولاية أو المنطقةالحالة
Research SiteBuenos Airesلم يبدأ التجنيد بعد
Research SiteCABAلم يبدأ التجنيد بعد
Research SiteCabaلم يبدأ التجنيد بعد
Research SiteCiudad de Buenos Airesلم يبدأ التجنيد بعد
Research SiteMar del Plataلم يبدأ التجنيد بعد
Research SiteSan Nicolásلم يبدأ التجنيد بعد
Research SiteSan Vicenteلم يبدأ التجنيد بعد
Research SiteSanta Feلم يبدأ التجنيد بعد

China

China
المنشأةالمدينةالولاية أو المنطقةالحالة
Research SiteBaotouلم يبدأ التجنيد بعد
Research SiteBinzhouلم يبدأ التجنيد بعد
Research SiteCangzhouلم يبدأ التجنيد بعد
Research SiteChangshaلم يبدأ التجنيد بعد
Research SiteChengduلم يبدأ التجنيد بعد
Research SiteGanzhouلم يبدأ التجنيد بعد
Research SiteHaikouلم يبدأ التجنيد بعد
Research SiteHangzhouلم يبدأ التجنيد بعد
Research SiteHuangshiلم يبدأ التجنيد بعد
Research SiteHuzhouلم يبدأ التجنيد بعد
Research SiteJinanلم يبدأ التجنيد بعد
Research SiteJinzhouلم يبدأ التجنيد بعد
Research SiteLanzhouلم يبدأ التجنيد بعد
Research SiteLianyungangلم يبدأ التجنيد بعد
Research SiteLiaochengلم يبدأ التجنيد بعد
Research SiteLiuzhouلم يبدأ التجنيد بعد
Research SiteLoudiلم يبدأ التجنيد بعد
Research SiteLuoyangلم يبدأ التجنيد بعد
Research SiteLuoyangلم يبدأ التجنيد بعد
Research SiteNanchangلم يبدأ التجنيد بعد
Research SiteNanjingلم يبدأ التجنيد بعد
Research SiteNanjingلم يبدأ التجنيد بعد
Research SiteNanyangلم يبدأ التجنيد بعد
Research SiteNingboلم يبدأ التجنيد بعد
Research SitePanjinلم يبدأ التجنيد بعد
Research SiteQingdaoلم يبدأ التجنيد بعد
Research SiteSanmenxiaلم يبدأ التجنيد بعد
Research SiteShanghaiلم يبدأ التجنيد بعد
Research SiteSuining Shiلم يبدأ التجنيد بعد
Research SiteTonghuaلم يبدأ التجنيد بعد
Research SiteXi'anلم يبدأ التجنيد بعد
Research SiteXiangtanلم يبدأ التجنيد بعد
Research SiteXuanchengلم يبدأ التجنيد بعد
Research SiteYibinلم يبدأ التجنيد بعد
Research SiteYichangلم يبدأ التجنيد بعد
Research SiteYunchengلم يبدأ التجنيد بعد
Research SiteZhengzhouلم يبدأ التجنيد بعد
Research SiteZhengzhouلم يبدأ التجنيد بعد
Research SiteZhenjiangلم يبدأ التجنيد بعد

Denmark

Denmark
المنشأةالمدينةالولاية أو المنطقةالحالة
Research SiteGandrupلم يبدأ التجنيد بعد
Research SiteHerlevلم يبدأ التجنيد بعد
Research SiteHillerødلم يبدأ التجنيد بعد

يُدرَج 99 موقعاً إضافياً في سجل السجل.

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

  1. 31 أغسطس 2026

    أُزيل موقع

    1 site removed (149 total)

    150149

  2. 4 أغسطس 2026

    أُضيف موقع

    1 site added (150 total)

    149150