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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)

מגייסמקבל משתתפים כעת, לפי רשומת המרשם.
יצירת קשר עם המחקר

בקצרה

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…

שלב 3דרושים 1,200 משתתפים209 אתרים15 מדינות

קטגוריות

אנדוקריני ומטבולי68%לב וכלי דם32%

רשום במרשם אחד

מחקר יחיד יכול להיות רשום בכמה מרשמים. אנו מציגים אותו פעם אחת ומקשרים לכל רשומה שברשותנו.

מידע הניסוי מוצג כפי שפורסם על ידי המרשם, בשפת המקור שלו.

מתעניינים במחקר הזה?

התחברות או צרו חשבון כדי לרשום את התעניינותכם ולעקוב אחר המחקר הזה.

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.

תקציר

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).

מצבים רפואיים

  • Type 2 Diabetes Mellitus

זכאות

מיןהכול
גילאים18 Years – ללא מקסימום
מתנדבים בריאיםלא

זכאות כפי שנכתבה במרשם

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

זכאות במשפטים פשוטים

הקריטריונים של רשומה זו טרם פורקו למשפטים נפרדים. טקסט המרשם שלמעלה שלם והוא הגרסה המחייבת.

תכנון המחקר

סוג המחקרהתערבותי
שלבשלב 3
הקצאהאקראי
מודל ההתערבותPARALLEL
מטרה ראשיתTREATMENT
הסתרהNONE (0)
גיוסדרושים 1,200 משתתפים

נותן חסות ושותפים

  • AstraZeneca נותן חסות

זרועות והתערבויות

  • 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.

התערבויות

  • תרופה Elecoglipron

    Elecoglipron is administered orally once daily.

  • תרופה Semaglutide

    Semaglutide is administered orally once daily.

מדדי תוצאה

  1. מדד תוצאה ראשוני

    Change from baseline in Hemoglobin A1c (HbA1c)

    מסגרת זמן Baseline to Week 52

  2. מדד תוצאה משני

    Percent change from baseline to Week 52 in body weight

    מסגרת זמן Baseline to Week 52

  3. מדד תוצאה משני

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

    מסגרת זמן Baseline to Week 52

  4. מדד תוצאה משני

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

    מסגרת זמן Baseline to Week 52

  5. מדד תוצאה משני

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

    מסגרת זמן Week 52

  6. מדד תוצאה משני

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

    מסגרת זמן Week 52

  7. מדד תוצאה משני

    Achieved ≥ 5% weight loss from baseline at Week 52

    מסגרת זמן Baseline to Week 52

  8. מדד תוצאה משני

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

    מסגרת זמן Baseline to Week 52

תאריכים

תאריך התחלה6 ביולי 2026 (בפועל)
סיום ראשוני23 במאי 2028 (משוער)
סיום23 במאי 2028 (משוער)
פורסם לראשונה23 ביוני 2026 (בפועל)
עודכן לאחרונה9 בספטמבר 2026
התוצאות פורסמולא צוין ברשומת המרשם
המצב אומת לאחרונהמאי 2026

בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.

מיקומים

51 אתרים מגייסים

Argentina

מתקןעירמדינה או אזורמצב
Research SiteBuenos Airesטרם מגייס
Research SiteBuenos Airesמגייס
Research SiteCabaטרם מגייס
Research SiteCiudad de Buenos Airesמגייס
Research SiteRosarioטרם מגייס
Research SiteSan Nicolásטרם מגייס
Research SiteSan Vicenteמגייס

Australia

מתקןעירמדינה או אזורמצב
Research SiteBotanyמגייס
Research SiteEast Toowoombaמגייס
Research SiteFitzroyטרם מגייס
Research SiteHeidelberg Heightsטרם מגייס
Research SiteKingswoodטרם מגייס
Research SiteMelbourneמגייס
Research SiteParkvilleמגייס
Research SitePenrithטרם מגייס
Research SiteSt Leonardsמגייס

Brazil

מתקןעירמדינה או אזורמצב
Research SiteBrasíliaטרם מגייס
Research SiteCampinasטרם מגייס
Research SiteCuritibaטרם מגייס
Research SiteNatalטרם מגייס
Research SitePorto Alegreטרם מגייס
Research SiteSão José dos Camposטרם מגייס
Research SiteSão Pauloטרם מגייס

Bulgaria

מתקןעירמדינה או אזורמצב
Research SitePlovdivמגייס
Research SiteSofiaמגייס
Research SiteSofiaטרם מגייס
Research SiteSofiaטרם מגייס
Research SiteYambolטרם מגייס

Canada

מתקןעירמדינה או אזורמצב
Research SiteGuelphOntarioטרם מגייס
Research SiteMontrealQuebecמגייס
Research SiteSaint-Charles-BorroméeQuebecמגייס
Research SiteSarniaOntarioמגייס
Research SiteScarborough VillageOntarioמגייס
Research SiteStouffvilleOntarioמגייס
Research SiteTorontoOntarioמגייס
Research SiteTorontoOntarioטרם מגייס
Research SiteTorontoOntarioמגייס
Research SiteVancouverBritish Columbiaמגייס

China

מתקןעירמדינה או אזורמצב
Research SiteChangshaטרם מגייס
Research SiteChangshaטרם מגייס
Research SiteHefeiטרם מגייס
Research SiteHefeiטרם מגייס
Research SiteHuai'anטרם מגייס
Research SiteLangfangטרם מגייס
Research SiteLiangyugangטרם מגייס
Research SiteLuoyangטרם מגייס
Research SiteNanjingטרם מגייס
Research SiteNanyangטרם מגייס
Research SitePingguטרם מגייס
Research SitePingxiangטרם מגייס

159 אתרים נוספים מצוינים ברשומת המרשם.

מסמכי המחקר

לא צורפו מסמכים ברשומת מרשם זו.

שינויים לאורך זמן

  1. 9 בספטמבר 2026

    אתר נוסף

    8 sites added (209 total)

    201209

מרשם: ClinicalTrials.gov · NCT########

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