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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)

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

בקצרה

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…

שלב 3דרושים 6,950 משתתפים672 אתרים32 מדינות

קטגוריות

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.

  • Present: Registered before enrolment beganFirst posted 2026-08-12; recorded start 2026-08-24
  • Present: Has a defined primary outcomeA primary outcome measure is listed in the record
  • Present: The primary outcome states a time frameThe primary outcome measure records a time frame
  • Present: Participants are randomly assignedAllocation is recorded as randomised
  • Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Present: Uses blinding (masking)A masking level is recorded in the record
  • Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • Not stated: 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.
  • Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Present: Sponsor has 1019 other studies in this databaseCounted from the lead sponsor named in the record (AstraZeneca)
  • Present: 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.

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.

תקציר

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.

מצבים רפואיים

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

זכאות

זכאות
מיןהכול
גילאים18 Yearsללא מקסימום
מתנדבים בריאיםלא

זכאות כפי שנכתבה במרשם

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.

זכאות במשפטים פשוטים

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

תכנון המחקר

תכנון המחקר
סוג המחקרהתערבותי
שלבשלב 3
הקצאהאקראי
מודל ההתערבותPARALLEL
מטרה ראשיתTREATMENT
הסתרהQUADRUPLE (4)
גיוסדרושים 6,950 משתתפים

נותן חסות ושותפים

  • AstraZeneca נותן חסות

זרועות והתערבויות

  • ElecoglipronEXPERIMENTAL

    Elecoglipron tablet once daily

  • PlaceboACTIVE_COMPARATOR

    Placebo matching Elecoglipron tablet once daily

התערבויות

  • תרופה Elecoglipron

    Elecoglipron tablet

  • תרופה Placebo

    Placebo tablet

מדדי תוצאה

  1. מדד תוצאה ראשוני

    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

    מסגרת זמן Up to 42 months

  2. מדד תוצאה משני

    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

    מסגרת זמן Up to 42 months

  3. מדד תוצאה משני

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

    Change from baseline to Week 52

    מסגרת זמן Baseline and 52 weeks

  4. מדד תוצאה משני

    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

    מסגרת זמן Up to 42 months

תאריכים

תאריכים
תאריך התחלה24 באוגוסט 2026 (בפועל)
סיום ראשוני3 בספטמבר 2029 (משוער)
סיום3 בספטמבר 2029 (משוער)
פורסם לראשונה12 באוגוסט 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

11 אתרים מגייסים

Argentina

Argentina
מתקןעירמדינה או אזורמצב
Research SiteBuenos Airesטרם מגייס
Research SiteCABAטרם מגייס
Research SiteCiudad de Buenos Airesטרם מגייס
Research SiteCiudad de Buenos Airesטרם מגייס
Research SiteCorrientesטרם מגייס
Research SiteCórdobaטרם מגייס
Research SiteCórdobaטרם מגייס
Research SiteCórdobaטרם מגייס
Research SiteEsperanzaטרם מגייס
Research SiteGranadero Baigorriaטרם מגייס
Research SiteLanusטרם מגייס
Research SiteMar del Plataטרם מגייס
Research SiteMendozaטרם מגייס
Research SiteRosarioטרם מגייס
Research SiteRosarioטרם מגייס
Research SiteSan Nicolásטרם מגייס
Research SiteSanta Feטרם מגייס

Australia

Australia
מתקןעירמדינה או אזורמצב
Research SiteBlacktownטרם מגייס
Research SiteCampbelltownטרם מגייס
Research SiteFrankstonטרם מגייס
Research SiteHoppers Crossingטרם מגייס
Research SiteNorth Tamworthטרם מגייס
Research SiteRockhamptonטרם מגייס

Austria

Austria
מתקןעירמדינה או אזורמצב
Research SiteBad Ischlטרם מגייס
Research SiteFeldkirchטרם מגייס
Research SiteGrazטרם מגייס
Research SiteGrazטרם מגייס
Research SiteInnsbruckטרם מגייס
Research SiteKlagenfurtטרם מגייס
Research SiteLinzטרם מגייס
Research SiteSaint Stefan/Stainzטרם מגייס
Research SiteSankt Pöltenטרם מגייס
Research SiteViennaטרם מגייס
Research SiteViennaטרם מגייס
Research SiteViennaטרם מגייס
Research SiteViennaטרם מגייס
Research SiteWelsטרם מגייס

Brazil

Brazil
מתקןעירמדינה או אזורמצב
Research SiteAracajuטרם מגייס
Research SiteBelémטרם מגייס
Research SiteBragança Paulistaטרם מגייס
Research SiteBrasíliaטרם מגייס
Research SiteCampinasטרם מגייס
Research SiteCuritibaטרם מגייס
Research SiteJoinvilleטרם מגייס
Research SiteNatalטרם מגייס
Research SitePorto Alegreטרם מגייס
Research SitePorto Alegreטרם מגייס
Research SiteRibeirão Pretoטרם מגייס
Research SiteRio Brancoטרם מגייס
Research SiteRio de Janeiroטרם מגייס

622 אתרים נוספים מצוינים ברשומת המרשם.

מסמכי המחקר

לא צורפו מסמכים ברשומת מרשם זו.

שינויים לאורך זמן

  1. 9 בספטמבר 2026

    המצב השתנה

    Status changed from Not yet recruiting to Recruiting

    NOT_YET_RECRUITINGRECRUITING

  2. 9 בספטמבר 2026

    הגיוס נפתח

    Recruitment opened

    NOT_YET_RECRUITINGRECRUITING

  3. 9 בספטמבר 2026

    אתר נוסף

    306 sites added (672 total)

    366672