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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)

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 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…

المرحلة 3مطلوب 1,200 مشارك209 مواقع15 دولة

الفئات

الغدد الصمّاء والأيض68%القلب والأوعية الدموية32%

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.

  • 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
  • Open label (no blinding)Masking is recorded as none (open label)
  • 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

  • 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.

ملخص

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 medication(s).

الحالات

  • Type 2 Diabetes Mellitus

الأهلية

الجنسالجميع
الأعمار18 Years – لا 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(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

الأهلية في عبارات بسيطة

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

تصميم الدراسة

نوع الدراسةتدخّلية
المرحلةالمرحلة 3
التخصيصمعشّاة
نموذج التدخّلPARALLEL
الغرض الأساسيTREATMENT
التعميةNONE (0)
التجنيدمطلوب 1,200 مشارك

الجهة الراعية والمتعاونون

  • AstraZeneca الجهة الراعية

الأذرع والتدخلات

  • 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.

التدخلات

  • دواء Elecoglipron

    Elecoglipron is administered orally once daily.

  • دواء Semaglutide

    Semaglutide is administered orally once daily.

مقاييس النتائج

  1. مقياس النتيجة الأولي

    Change from baseline in Hemoglobin A1c (HbA1c)

    الإطار الزمني Baseline to Week 52

  2. مقياس النتيجة الثانوي

    Percent change from baseline to Week 52 in body weight

    الإطار الزمني Baseline to Week 52

  3. مقياس النتيجة الثانوي

    Change from baseline to Week 52 in body weight (kg)

    الإطار الزمني Baseline to Week 52

  4. مقياس النتيجة الثانوي

    Achieved ≥ 5% weight loss from baseline at Week 52 and achieved HbA1c < 7% (53 mmol/mol) at Week 52

    الإطار الزمني Baseline to Week 52

  5. مقياس النتيجة الثانوي

    Achieved HbA1c ≤ 6.5% (48 mmol/mol) at Week 52

    الإطار الزمني Week 52

  6. مقياس النتيجة الثانوي

    Achieved HbA1c < 7% (53 mmol/mol) at Week 52

    الإطار الزمني Week 52

  7. مقياس النتيجة الثانوي

    Achieved ≥ 5% weight loss from baseline at Week 52

    الإطار الزمني Baseline to Week 52

  8. مقياس النتيجة الثانوي

    Change from baseline to Week 52 in Systolic Blood Pressure (BP) and Diastolic BP

    الإطار الزمني Baseline to Week 52

التواريخ

تاريخ البدء6 يوليو 2026 (فعلي)
الإتمام الأولي23 مايو 2028 (تقديري)
الإتمام23 مايو 2028 (تقديري)
أول نشر23 يونيو 2026 (فعلي)
آخر تحديث9 سبتمبر 2026
النتائج منشورةغير مذكور في سجل السجل
آخر تأكيد للحالةمايو 2026

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

المواقع

51 موقعاً قيد التجنيد

Argentina

المنشأةالمدينةالولاية أو المنطقةالحالة
Research SiteBuenos Airesلم يبدأ التجنيد بعد
Research SiteBuenos Airesقيد التجنيد
Research SiteCabaلم يبدأ التجنيد بعد
Research SiteCiudad de Buenos Airesقيد التجنيد
Research SiteRosarioلم يبدأ التجنيد بعد
Research SiteSan Nicolásلم يبدأ التجنيد بعد
Research SiteSan Vicenteقيد التجنيد

Australia

المنشأةالمدينةالولاية أو المنطقةالحالة
Research SiteBotanyقيد التجنيد
Research SiteEast Toowoombaقيد التجنيد
Research SiteFitzroyلم يبدأ التجنيد بعد
Research SiteHeidelberg Heightsلم يبدأ التجنيد بعد
Research SiteKingswoodلم يبدأ التجنيد بعد
Research SiteMelbourneقيد التجنيد
Research SiteParkvilleقيد التجنيد
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Brazil

المنشأةالمدينةالولاية أو المنطقةالحالة
Research SiteBrasíliaلم يبدأ التجنيد بعد
Research SiteCampinasلم يبدأ التجنيد بعد
Research SiteCuritibaلم يبدأ التجنيد بعد
Research SiteNatalلم يبدأ التجنيد بعد
Research SitePorto Alegreلم يبدأ التجنيد بعد
Research SiteSão José dos Camposلم يبدأ التجنيد بعد
Research SiteSão Pauloلم يبدأ التجنيد بعد

Bulgaria

المنشأةالمدينةالولاية أو المنطقةالحالة
Research SitePlovdivقيد التجنيد
Research SiteSofiaقيد التجنيد
Research SiteSofiaلم يبدأ التجنيد بعد
Research SiteSofiaلم يبدأ التجنيد بعد
Research SiteYambolلم يبدأ التجنيد بعد

Canada

المنشأةالمدينةالولاية أو المنطقةالحالة
Research SiteGuelphOntarioلم يبدأ التجنيد بعد
Research SiteMontrealQuebecقيد التجنيد
Research SiteSaint-Charles-BorroméeQuebecقيد التجنيد
Research SiteSarniaOntarioقيد التجنيد
Research SiteScarborough VillageOntarioقيد التجنيد
Research SiteStouffvilleOntarioقيد التجنيد
Research SiteTorontoOntarioقيد التجنيد
Research SiteTorontoOntarioلم يبدأ التجنيد بعد
Research SiteTorontoOntarioقيد التجنيد
Research SiteVancouverBritish Columbiaقيد التجنيد

China

المنشأةالمدينةالولاية أو المنطقةالحالة
Research SiteChangshaلم يبدأ التجنيد بعد
Research SiteChangshaلم يبدأ التجنيد بعد
Research SiteHefeiلم يبدأ التجنيد بعد
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Research SiteHuai'anلم يبدأ التجنيد بعد
Research SiteLangfangلم يبدأ التجنيد بعد
Research SiteLiangyugangلم يبدأ التجنيد بعد
Research SiteLuoyangلم يبدأ التجنيد بعد
Research SiteNanjingلم يبدأ التجنيد بعد
Research SiteNanyangلم يبدأ التجنيد بعد
Research SitePingguلم يبدأ التجنيد بعد
Research SitePingxiangلم يبدأ التجنيد بعد

يُدرَج 159 موقعاً إضافياً في سجل السجل.

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

  1. 9 سبتمبر 2026

    أُضيف موقع

    8 sites added (209 total)

    201209

السجل: ClinicalTrials.gov · NCT########

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