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NCT07667803ClinicalTrials.gov

A Master Protocol to Investigate Efficacy and Safety of Elecoglipron in Participants With Obesity or Overweight With or Without T2DM

A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Master Protocol to Evaluate the Efficacy and Safety of Elecoglipron in Participants With Obesity or Overweight With or Without Type 2 Diabetes Mellitus (Embold)

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

בקצרה

This master study protocol, Study D7260C00015, covers 2 independent, pivotal studies, Study 1 and Study 2. Each study is a global, randomized, double-blind, parallel-group, multicenter, Phase III study to assess the efficacy and safety of elecoglipron compared with placebo adjunct…

שלב 3דרושים 4,500 משתתפים325 אתרים19 מדינות

קטגוריות

אנדוקריני ומטבולי100%

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 2026-06-25; recorded start 2026-06-29
  • 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

  • Blinding16/20

    Triple-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: 321 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: 4,500 participants (target), run at 325 sites, across 19 countries.

How this score is built
  • Enrolment35/40

    4,500 participants (target)

  • Site count25/25

    321 sites

  • Country count15/15

    19 countries

  • Planned duration8/10

    Planned over about 38 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

This master study protocol, Study D7260C00015, covers 2 independent, pivotal studies, Study 1 and Study 2. Each study is a global, randomized, double-blind, parallel-group, multicenter, Phase III study to assess the efficacy and safety of elecoglipron compared with placebo adjunct to diet and exercise for weight management, in adults living with obesity or overweight with at least one weight-related comorbidity, and without T2DM (Study 1) or with T2DM (Study 2).

This is a Phase III, global, randomized, parallel-group, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of 2 doses of elecoglipron compared with placebo, given once daily as oral tablets. This protocol covers two independent pivotal studies in adults aged 18 years and above, who are living with obesity (BMI ≥ 30 kg/m2), or overweight (BMI ≥ 25 kg/m2) and have at least 1 weight-related comorbidity (Hypertension, Prediabetes, Dyslipidemia, CV disease and/or Obstructive sleep apnea) without T2DM (Study 1) and as well as those who are living with obesity or overweight with T2DM (Study 2). Approximately 3000 participants will be randomized in the study 1 and 1500 participants in the study 2. The primary endpoint is percent change in body weight from baseline at 72 weeks.

מצבים רפואיים

  • Weight Management

זכאות

מיןהכול
גילאים18 Years – ללא מקסימום
מתנדבים בריאיםלא

זכאות כפי שנכתבה במרשם

Inclusion Criteria * Legal age of consent and at least 18 years old * Study 1 - * BMI ≥ 30 kg/m2 or * 25 kg/m2 ≤ BMI \< 30 kg/m2 with at least one of the following weight-related comorbidities: * Hypertension * Prediabetes * Dyslipidemia * Cardiovascular disease * Obstructive sleep apnea. * Study 2 - BMI ≥ 25 kg/m2 and T2DM defined as below: * Established diagnosis of T2DM * Without established diagnosis of T2DM and HbA1c ≥ 6.5% (48 mmol/mol) at the screening visit * Stable body weight (self-reported or documented) for 90 days prior to the screening visit (± 5% body weight change) * History of at least one self-reported unsuccessful dietary effort to lose body weight. Exclusion Criteria * Study 1 - Established diagnosis of T1DM or T2DM. * Study 2 - Any of the following medical history, laboratory values, or complications related to diabetes: * T1DM * HbA1c ≥ 10% (86 mmol/mol) at the screening visit * 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 the screening visit, or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms * History of acute (unless due to previously resolved gallstone pancreatitis and post-cholecystectomy) or chronic pancreatitis * History/family history (first degree biologic relatives) 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
הסתרהTRIPLE (3)
גיוסדרושים 4,500 משתתפים

נותן חסות ושותפים

  • AstraZeneca נותן חסות

זרועות והתערבויות

  • Arm 1 - Dose 1EXPERIMENTAL

    Active IMP

  • Arm 2 - Dose 2EXPERIMENTAL

    Active IMP

  • Arm 3 - PlaceboPLACEBO_COMPARATOR

    Placebo matching elecoglipron

התערבויות

  • תרופה Elecoglipron

    Elecoglipron film-coated tablet once daily

  • תרופה Placebo

    Placebo matching elecoglipron film-coated tablet once daily

מדדי תוצאה

  1. מדד תוצאה ראשוני

    Percent body weight loss

    Percent change from baseline to Week 72 in body weight

    מסגרת זמן 72 weeks

  2. מדד תוצאה משני

    Absolute body weight loss

    Absolute change from baseline to Week 72 in body weight (kg)

    מסגרת זמן 72 weeks

  3. מדד תוצאה משני

    Total body weight loss of at least 5%, 10%, and 15%

    * Achieved ≥ 5% body weight loss from baseline at Week 72 * Achieved ≥ 10% body weight loss from baseline at Week 72 * Achieved ≥ 15% body weight loss from baseline at Week 72

    מסגרת זמן 72 weeks

  4. מדד תוצאה משני

    Percent body weight loss in participants with body mass index (BMI) ≥ 27 kg/m2 at baseline

    Percent change from baseline to Week 72 in body weight

    מסגרת זמן 72 weeks

  5. מדד תוצאה משני

    Waist circumference reduction

    Absolute change from baseline to Week 72 in waist circumference (cm)

    מסגרת זמן 72 weeks

  6. מדד תוצאה משני

    Glycemic control

    Change from baseline to Week 72 in hemoglobin A1c (HbA1c) (%)

    מסגרת זמן 72 weeks

  7. מדד תוצאה משני

    Achieving normoglycemia in participants with HbA1c ≥ 5.7% (39 mmol/mol) at baseline

    Achieved normoglycemia (HbA1c \< 5.7% \[39 mmol/mol\]) at Week 72

    מסגרת זמן 72 weeks

  8. מדד תוצאה משני

    Study 2 only: Achieving glycemic control in participants with HbA1c ≥ 7.0% (53 mmol/mol) at baseline

    * Achieved HbA1c \< 7.0% (53 mmol/mol) at Week 72 * Achieved HbA1c ≤ 6.5% (48 mmol/mol) at Week 72

    מסגרת זמן 72 weeks

  9. מדד תוצאה משני

    Systolic blood pressure reduction

    Change from baseline to Week 72 in systolic blood pressure (mmHg)

    מסגרת זמן 72 weeks

תאריכים

תאריך התחלה29 ביוני 2026 (בפועל)
סיום ראשוני31 ביולי 2028 (משוער)
סיום30 ביולי 2029 (משוער)
פורסם לראשונה25 ביוני 2026 (בפועל)
עודכן לאחרונה9 בספטמבר 2026
התוצאות פורסמולא צוין ברשומת המרשם
המצב אומת לאחרונהספטמבר 2026

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

מיקומים

109 אתרים מגייסים

Argentina

מתקןעירמדינה או אזורמצב
Research SiteBuenos Airesמגייס
Research SiteBuenos Airesמגייס
Research SiteCABAטרם מגייס
Research SiteCABAמגייס
Research SiteCabaמגייס
Research SiteCapital Federalמגייס
Research SiteGranadero Baigorriaטרם מגייס
Research SiteLanusטרם מגייס
Research SiteRosarioמגייס
Research SiteRosarioטרם מגייס
Research SiteSan Nicolásטרם מגייס
Research SiteSan Vicenteטרם מגייס

Australia

מתקןעירמדינה או אזורמצב
Research SiteBotanyמגייס
Research SiteCamberwellמגייס
Research SiteCharlestownמגייס
Research SiteMaroubraמגייס
Research SiteSt Albansמגייס
Research SiteSt Leonardsמגייס

Brazil

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

Canada

מתקןעירמדינה או אזורמצב
Research SiteBramptonOntarioמגייס
Research SiteCalgaryAlbertaמגייס
Research SiteCalgaryAlbertaטרם מגייס
Research SiteHamiltonOntarioמגייס
Research SiteJolietteQuebecמגייס
Research SiteMonctonNew Brunswickמגייס
Research SiteMontrealQuebecמגייס
Research SiteNiagara FallsOntarioמגייס
Research SiteNorth YorkOntarioמגייס
Research SiteSaint-LambertQuebecמגייס
Research SiteSarniaOntarioמגייס
Research SiteScarborough VillageOntarioמגייס
Research SiteStouffvilleOntarioמגייס
Research SiteTerrebonneQuebecמגייס
Research SiteTorontoOntarioמגייס
Research SiteTorontoOntarioמגייס
Research SiteTorontoOntarioמגייס
Research SiteTruroNova Scotiaמגייס
Research SiteVancouverBritish Columbiaמגייס
Research SiteVictoriaBritish Columbiaמגייס

Chile

מתקןעירמדינה או אזורמצב
Research SiteAraucaniaטרם מגייס

275 אתרים נוספים מצוינים ברשומת המרשם.

מסמכי המחקר

לא צורפו מסמכים ברשומת מרשם זו.

שינויים לאורך זמן

  1. 9 בספטמבר 2026

    אתר נוסף

    4 sites added (325 total)

    321325

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

https://xmedica.io/trials/ctgov/NCT07667803