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NCT07761117ClinicalTrials.gov

A Study to Investigate CV Outcomes With Elecoglipron Compared With Placebo in Adult Participants With HFpEF or HFmrEF

A Phase III, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Study to Evaluate the Effect of Elecoglipron in Reducing Cardiovascular Outcomes in Participants With HFpEF and HFmrEF (Elevate-HF)

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

باختصار

This is a Phase III, randomized, double-blind, parallel-group, placebo-controlled, multicenter study to investigate CV outcomes with elecoglipron compared with placebo, in adults with heart failure with preserved ejection fraction (HFpEF)/heart failure with mildly reduced ejection fraction (HFmrEF), irrespective of T2DM…

المرحلة 3مطلوب 6,950 مشاركاً672 موقعاً32 دولة

الفئات

القلب والأوعية الدموية100%

مسجَّلة في سجل واحد

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

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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 2026-08-12; recorded start 2026-08-24
  • 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 2 conditions.
  • 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 rigourDEFINITIVE

A definitive-grade 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 arm15/15

    Active-comparator control arm

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type10/10

    Mortality / MACE endpoint (hard clinical outcome)

  • Multi-centre8/8

    Multi-centre: 366 sites

  • Data monitoring committee7/7

    A data monitoring committee is in place

  • 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: 6,950 participants (target), run at 672 sites, across 32 countries.

How this score is built
  • Enrolment37/40

    6,950 participants (target)

  • Site count25/25

    366 sites

  • Country count15/15

    25 countries

  • Planned duration8/10

    Planned over about 37 months

  • Sponsor scale10/10

    AstraZeneca has led 1,005 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 is a Phase III, randomized, double-blind, parallel-group, placebo-controlled, multicenter study to investigate CV outcomes with elecoglipron compared with placebo, in adults with heart failure with preserved ejection fraction (HFpEF)/heart failure with mildly reduced ejection fraction (HFmrEF), irrespective of T2DM status, and who are on background dapagliflozin in addition to other background standard of care.

الحالات

  • Heart Failure With Preserved Ejection Fraction (HFpEF)
  • Heart Failure With Mildly Reduced Ejection Fraction (HFmrEF)

الأهلية

الجنسالجميع
الأعمار18 Years – لا حد أقصى
المتطوعون الأصحّاءلا

الأهلية كما كُتبت في السجل

Inclusion Criteria: * Left ventricular ejection fraction (LVEF) of \> 40% within 12 months prior to screening. * Structural heart disease evidence. * HF diagnosed with New York Heart Association (NYHA) Class II-IV at the time of screening. Exclusion Criteria: * BMI \<25 kg/m² at screening. * Diabetes exclusions: * History of type 1 diabetes. * HbA1c ≥10% at screening. * Currently receiving or anticipated to receive therapeutic intervention for diabetic retinopathy and/or macular edema. * more than 1 episode of severe hypoglycemic event within 180 days prior to screening, or hypoglycemia unawareness/poor recognition. * Renal exclusions: * On a prespecified renal replacement therapy, or eGFR below a prespecified threshold at screening * Cardiovascular exclusions: * Major cardiac surgery, coronary revascularization, valvular repair/replacement, AF/AFL ablation, CRT implantation, or ICD without CRT within 90 days prior to screening, or planned after randomization. * Heart failure due to infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, genetic hypertrophic cardiomyopathy (including obstructive), or arrhythmogenic right ventricular cardiomyopathy/dysplasia. * GI exclusions: * Clinically significant upper GI condition affecting gastric emptying, drug absorption, or safety/tolerability interpretation; chronic use of drugs directly affecting GI motility; severe disease or prior surgery. * History of acute or chronic pancreatitis. * Endocrine exclusions: * History/ family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2, or basal calcitonin ≥35 ng/L at screening.

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
التعميةQUADRUPLE (4)
التجنيدمطلوب 6,950 مشاركاً

الجهة الراعية والمتعاونون

  • AstraZeneca الجهة الراعية

الأذرع والتدخلات

  • ElecoglipronEXPERIMENTAL

    Elecoglipron tablet once daily

  • PlaceboACTIVE_COMPARATOR

    Placebo matching Elecoglipron tablet once daily

التدخلات

  • دواء Elecoglipron

    Elecoglipron tablet

  • دواء Placebo

    Placebo tablet

مقاييس النتائج

  1. مقياس النتيجة الأولي

    To evaluate the effect of elecoglipron compared with placebo in reducing the risk of CV death or HHF/urgent HF visit

    Time to first event of the composite of: * CV death * HHF * Urgent HF visit

    الإطار الزمني Up to 42 months

  2. مقياس النتيجة الثانوي

    To evaluate the effect of elecoglipron compared with placebo in reducing the rate of HF events (HHF or urgent HF visit)

    Total occurrences (first and recurrent) of: * HF events * HHF * Urgent HF visit

    الإطار الزمني Up to 42 months

  3. مقياس النتيجة الثانوي

    To evaluate the effect of elecoglipron compared to placebo on improving patient-reported outcomes using a questionnaire.

    Change from baseline to Week 52

    الإطار الزمني Baseline and 52 weeks

  4. مقياس النتيجة الثانوي

    To evaluate the effect of elecoglipron compared with placebo in reducing the risk of the 4-point composite of all-cause death, HHF, MI, or stroke

    Time to first event of the composite of: * All-cause death * HHF * MI * Stroke

    الإطار الزمني Up to 42 months

التواريخ

تاريخ البدء24 أغسطس 2026 (فعلي)
الإتمام الأولي3 سبتمبر 2029 (تقديري)
الإتمام3 سبتمبر 2029 (تقديري)
أول نشر12 أغسطس 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

11 موقعاً قيد التجنيد

Argentina

المنشأةالمدينةالولاية أو المنطقةالحالة
Research SiteBuenos Airesلم يبدأ التجنيد بعد
Research SiteCABAلم يبدأ التجنيد بعد
Research SiteCiudad de Buenos Airesلم يبدأ التجنيد بعد
Research SiteCiudad de Buenos Airesلم يبدأ التجنيد بعد
Research SiteCorrientesلم يبدأ التجنيد بعد
Research SiteCórdobaلم يبدأ التجنيد بعد
Research SiteCórdobaلم يبدأ التجنيد بعد
Research SiteCórdobaلم يبدأ التجنيد بعد
Research SiteEsperanzaلم يبدأ التجنيد بعد
Research SiteGranadero Baigorriaلم يبدأ التجنيد بعد
Research SiteLanusلم يبدأ التجنيد بعد
Research SiteMar del Plataلم يبدأ التجنيد بعد
Research SiteMendozaلم يبدأ التجنيد بعد
Research SiteRosarioلم يبدأ التجنيد بعد
Research SiteRosarioلم يبدأ التجنيد بعد
Research SiteSan Nicolásلم يبدأ التجنيد بعد
Research SiteSanta Feلم يبدأ التجنيد بعد

Australia

المنشأةالمدينةالولاية أو المنطقةالحالة
Research SiteBlacktownلم يبدأ التجنيد بعد
Research SiteCampbelltownلم يبدأ التجنيد بعد
Research SiteFrankstonلم يبدأ التجنيد بعد
Research SiteHoppers Crossingلم يبدأ التجنيد بعد
Research SiteNorth Tamworthلم يبدأ التجنيد بعد
Research SiteRockhamptonلم يبدأ التجنيد بعد

Austria

المنشأةالمدينةالولاية أو المنطقةالحالة
Research SiteBad Ischlلم يبدأ التجنيد بعد
Research SiteFeldkirchلم يبدأ التجنيد بعد
Research SiteGrazلم يبدأ التجنيد بعد
Research SiteGrazلم يبدأ التجنيد بعد
Research SiteInnsbruckلم يبدأ التجنيد بعد
Research SiteKlagenfurtلم يبدأ التجنيد بعد
Research SiteLinzلم يبدأ التجنيد بعد
Research SiteSaint Stefan/Stainzلم يبدأ التجنيد بعد
Research SiteSankt Pöltenلم يبدأ التجنيد بعد
Research SiteViennaلم يبدأ التجنيد بعد
Research SiteViennaلم يبدأ التجنيد بعد
Research SiteViennaلم يبدأ التجنيد بعد
Research SiteViennaلم يبدأ التجنيد بعد
Research SiteWelsلم يبدأ التجنيد بعد

Brazil

المنشأةالمدينةالولاية أو المنطقةالحالة
Research SiteAracajuلم يبدأ التجنيد بعد
Research SiteBelémلم يبدأ التجنيد بعد
Research SiteBragança Paulistaلم يبدأ التجنيد بعد
Research SiteBrasíliaلم يبدأ التجنيد بعد
Research SiteCampinasلم يبدأ التجنيد بعد
Research SiteCuritibaلم يبدأ التجنيد بعد
Research SiteJoinvilleلم يبدأ التجنيد بعد
Research SiteNatalلم يبدأ التجنيد بعد
Research SitePorto Alegreلم يبدأ التجنيد بعد
Research SitePorto Alegreلم يبدأ التجنيد بعد
Research SiteRibeirão Pretoلم يبدأ التجنيد بعد
Research SiteRio Brancoلم يبدأ التجنيد بعد
Research SiteRio de Janeiroلم يبدأ التجنيد بعد

يُدرَج 622 موقعاً إضافياً في سجل السجل.

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

  1. 9 سبتمبر 2026

    تغيّرت الحالة

    Status changed from Not yet recruiting to Recruiting

    NOT_YET_RECRUITINGRECRUITING

  2. 9 سبتمبر 2026

    فُتح التجنيد

    Recruitment opened

    NOT_YET_RECRUITINGRECRUITING

  3. 9 سبتمبر 2026

    أُضيف موقع

    306 sites added (672 total)

    366672

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

https://xmedica.io/trials/ctgov/NCT07761117