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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)

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

باختصار

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…

المرحلة 3مطلوب 4,500 مشارك325 موقعاً19 دولة

الفئات

الغدد الصمّاء والأيض100%

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؟

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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 2026-06-25; 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.

ملخص

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.

الحالات

  • Weight Management

الأهلية

الجنسالجميع
الأعمار18 Years – لا حد أقصى
المتطوعون الأصحّاءلا

الأهلية كما كُتبت في السجل

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

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
التعميةTRIPLE (3)
التجنيدمطلوب 4,500 مشارك

الجهة الراعية والمتعاونون

  • AstraZeneca الجهة الراعية

الأذرع والتدخلات

  • Arm 1 - Dose 1EXPERIMENTAL

    Active IMP

  • Arm 2 - Dose 2EXPERIMENTAL

    Active IMP

  • Arm 3 - PlaceboPLACEBO_COMPARATOR

    Placebo matching elecoglipron

التدخلات

  • دواء Elecoglipron

    Elecoglipron film-coated tablet once daily

  • دواء Placebo

    Placebo matching elecoglipron film-coated tablet once daily

مقاييس النتائج

  1. مقياس النتيجة الأولي

    Percent body weight loss

    Percent change from baseline to Week 72 in body weight

    الإطار الزمني 72 weeks

  2. مقياس النتيجة الثانوي

    Absolute body weight loss

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

    الإطار الزمني 72 weeks

  3. مقياس النتيجة الثانوي

    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

    الإطار الزمني 72 weeks

  4. مقياس النتيجة الثانوي

    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

    الإطار الزمني 72 weeks

  5. مقياس النتيجة الثانوي

    Waist circumference reduction

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

    الإطار الزمني 72 weeks

  6. مقياس النتيجة الثانوي

    Glycemic control

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

    الإطار الزمني 72 weeks

  7. مقياس النتيجة الثانوي

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

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

    الإطار الزمني 72 weeks

  8. مقياس النتيجة الثانوي

    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

    الإطار الزمني 72 weeks

  9. مقياس النتيجة الثانوي

    Systolic blood pressure reduction

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

    الإطار الزمني 72 weeks

التواريخ

تاريخ البدء29 يونيو 2026 (فعلي)
الإتمام الأولي31 يوليو 2028 (تقديري)
الإتمام30 يوليو 2029 (تقديري)
أول نشر25 يونيو 2026 (فعلي)
آخر تحديث9 سبتمبر 2026
النتائج منشورةغير مذكور في سجل السجل
آخر تأكيد للحالةسبتمبر 2026

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

المواقع

109 مواقع قيد التجنيد

Argentina

المنشأةالمدينةالولاية أو المنطقةالحالة
Research SiteBuenos Airesقيد التجنيد
Research SiteBuenos Airesقيد التجنيد
Research SiteCABAلم يبدأ التجنيد بعد
Research SiteCABAقيد التجنيد
Research SiteCabaقيد التجنيد
Research SiteCapital Federalقيد التجنيد
Research SiteGranadero Baigorriaلم يبدأ التجنيد بعد
Research SiteLanusلم يبدأ التجنيد بعد
Research SiteRosarioقيد التجنيد
Research SiteRosarioلم يبدأ التجنيد بعد
Research SiteSan Nicolásلم يبدأ التجنيد بعد
Research SiteSan Vicenteلم يبدأ التجنيد بعد

Australia

المنشأةالمدينةالولاية أو المنطقةالحالة
Research SiteBotanyقيد التجنيد
Research SiteCamberwellقيد التجنيد
Research SiteCharlestownقيد التجنيد
Research SiteMaroubraقيد التجنيد
Research SiteSt Albansقيد التجنيد
Research SiteSt Leonardsقيد التجنيد

Brazil

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

Canada

المنشأةالمدينةالولاية أو المنطقةالحالة
Research SiteBramptonOntarioقيد التجنيد
Research SiteCalgaryAlbertaقيد التجنيد
Research SiteCalgaryAlbertaلم يبدأ التجنيد بعد
Research SiteHamiltonOntarioقيد التجنيد
Research SiteJolietteQuebecقيد التجنيد
Research SiteMonctonNew Brunswickقيد التجنيد
Research SiteMontrealQuebecقيد التجنيد
Research SiteNiagara FallsOntarioقيد التجنيد
Research SiteNorth YorkOntarioقيد التجنيد
Research SiteSaint-LambertQuebecقيد التجنيد
Research SiteSarniaOntarioقيد التجنيد
Research SiteScarborough VillageOntarioقيد التجنيد
Research SiteStouffvilleOntarioقيد التجنيد
Research SiteTerrebonneQuebecقيد التجنيد
Research SiteTorontoOntarioقيد التجنيد
Research SiteTorontoOntarioقيد التجنيد
Research SiteTorontoOntarioقيد التجنيد
Research SiteTruroNova Scotiaقيد التجنيد
Research SiteVancouverBritish Columbiaقيد التجنيد
Research SiteVictoriaBritish Columbiaقيد التجنيد

Chile

المنشأةالمدينةالولاية أو المنطقةالحالة
Research SiteAraucaniaلم يبدأ التجنيد بعد

يُدرَج 275 موقعاً إضافياً في سجل السجل.

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

  1. 9 سبتمبر 2026

    أُضيف موقع

    4 sites added (325 total)

    321325

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

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