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

Part of paid clinical trials in Fairhope, Alabama.

Sponsor
AstraZeneca
Study ID
NCT07761117
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Elecoglipron — DRUG
    Elecoglipron tablet
  • Placebo — DRUG
    Placebo tablet

Study Details

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.

Key Dates

First listed
Aug 12, 2026
Start date
Aug 28, 2026
Status verified
Aug 2026
Primary completion
Sep 3, 2029
Completion
Sep 3, 2029

Study Design

Enrollment
6,950 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Elecoglipron
    Elecoglipron tablet once daily
  • Active Comparator: Placebo
    Placebo matching Elecoglipron tablet once daily

Primary Outcome Measure

To evaluate the effect of elecoglipron compared with placebo in reducing the risk of CV death or HHF/urgent HF visit [ Time Frame: Up to 42 months ]

Central Contacts

Locations (69)

FacilityCityStateZIPSite coordinators
Research SiteFairhopeAlabama36532-
Research SiteBeverly HillsCalifornia90211-
Research SiteHuntington BeachCalifornia92647-
Research SiteHuntington ParkCalifornia90255-
Research SiteLoma LindaCalifornia92350-
Research SiteLomitaCalifornia90717-
Research SiteNorthridgeCalifornia91324-
Research SiteTarzanaCalifornia91356-
Research SiteNew HavenConnecticut06519-
Research SiteHialeahFlorida33012-
Research SiteJacksonvilleFlorida32209-
Research SiteLakelandFlorida33813-
Research SiteMiamiFlorida33125-
Research SiteMiamiFlorida33144-
Research SiteAtlantaGeorgia30303-
Research SiteColumbusGeorgia31904-
Research SiteTuckerGeorgia30084-
Research SiteChampaignIllinois61822-
Research SitePark RidgeIllinois60068-
Research SiteSchaumburgIllinois60173-
Research SiteIndianapolisIndiana46254-
Research SiteWaterlooIowa50701-
Research SiteBossier CityLouisiana71111-
Research SiteCovingtonLouisiana70433-
Research SiteLafayetteLouisiana70503-
Research SiteNew OrleansLouisiana70121-
Research SiteShreveportLouisiana71105-
Research SiteBaltimoreMaryland21229-
Research SiteLanhamMaryland20706-
Research SiteOxon HillMaryland20745-
Research SiteBostonMassachusetts02114-
Research SiteBostonMassachusetts02118-
Research SiteNew BedfordMassachusetts02740-
Research SiteWorcesterMassachusetts01655-
Research SiteFlintMichigan48503-
Research SiteSouthfieldMichigan48076-
Research SiteKansas CityMissouri64111-
Research SiteSt LouisMissouri63136-
Research SiteMillvilleNew Jersey08332-
Research SiteTrentonNew Jersey08690-
Research SiteBuffaloNew York14215-
Research SiteNew YorkNew York10001-
Research SiteThe BronxNew York10451-
Research SiteThe BronxNew York10455-
Research SiteChapel HillNorth Carolina27599-
Research SiteDurhamNorth Carolina27710-
Research SiteGreensboroNorth Carolina27410-
Research SiteStatesvilleNorth Carolina28625-
Research SiteWilmingtonNorth Carolina28401-
Research SiteFargoNorth Dakota58104-
Research SiteGrand ForksNorth Dakota58201-
Research SiteColumbusOhio43228-
Research SiteDaytonOhio45435-
Research SiteMaumeeOhio43537-
Research SiteOklahoma CityOklahoma73134-
Research SitePhiladelphiaPennsylvania19104-
Research SitePhiladelphiaPennsylvania19107-
Research SiteYardleyPennsylvania19067-
Research SiteDeSotoTexas75115-
Research SiteEl PasoTexas79905-
Research SiteHoustonTexas77025-
Research SiteHumbleTexas77338-
Research SiteLancasterTexas75216-
Research SitePlanoTexas75093-
Research SiteSan AntonioTexas78231-
Research SiteVictoriaTexas77901-
Research SiteBurlingtonVermont05401-
Research SiteArlingtonVirginia22205-
Research SiteRedmondWashington98052-

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