A Phase III Study to Assess the Effect of AZD0780 on LDL-C in Patients With Clinical ASCVD or at Risk for a First ASCVD Event

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
AstraZeneca
Study ID
NCT07000123
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Cardiovascular Disease

Eligibility Criteria

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

Interventions

  • AZD0780 — DRUG
    Participants will receive daily oral dose of AZD0780
  • Placebo — DRUG
    Participants will receive daily oral dose of placebo

Study Details

This is a study to evaluate the efficacy and safety of AZD0780 in adults with clinical ASCVD or who are at risk for a first ASCVD event and who have elevated LDL-C. AZD0780 is a small molecule that reduces the amount of LDL-C in the blood. Placebo will be used for comparison, and neither the participants nor the Investigators will know who is receiving the AZD0780 medication and who is receiving the placebo until the end of study. The total length of the study for an individual participant will be up to approximately 56 weeks, including a screening period of up to 14 days, treatment with AZD0780 or placebo for 52 weeks, and a safety follow-up period of 10 days.

Key Dates

Start date
May 28, 2025
Status verified
May 2026
Primary completion
Jan 11, 2027
Completion
Jan 11, 2027

Study Design

Enrollment
3,103 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AZD0780
    Participants will receive daily oral dose of AZD0780
  • Placebo Comparator: Placebo
    Participants will receive daily oral dose of placebo

Primary Outcome Measure

Relative change in LDL-C from baseline to 12 weeks [ Time Frame: Baseline - 12 weeks ]

Locations (101)

FacilityCityStateZIPSite coordinators
Research SiteHuntsvilleAlabama35801-
Research SiteIrondaleAlabama35210-
Research SiteMobileAlabama36608-
Research SiteGilbertArizona85296-
Research SitePhoenixArizona85014-
Research SiteSun City WestArizona85375-
Research SiteGarden GroveCalifornia92844-
Research SiteGardenaCalifornia90247-
Research SiteLancasterCalifornia93534-
Research SiteLincolnCalifornia95648-
Research SiteSan DiegoCalifornia92103-
Research SiteSan DiegoCalifornia92111-
Research SiteTorranceCalifornia90502-
Research SiteWest HillsCalifornia91307-
Research SiteHamdenConnecticut06517-
Research SiteBoca RatonFlorida33434-
Research SiteHallandaleFlorida33009-
Research SiteHialeahFlorida33012-
Research SiteInvernessFlorida34452-
Research SiteJacksonvilleFlorida32216-
Research SiteMiamiFlorida33176-
Research SiteNew Port RicheyFlorida34653-
Research SiteOrlandoFlorida32807-
Research SitePembroke PinesFlorida33029-
Research SiteSeminoleFlorida33777-
Research SiteTampaFlorida33625-
Research SiteAtlantaGeorgia30328-
Research SiteAtlantaGeorgia30342-
Research SiteDecaturGeorgia30030-
Research SitePeachtree CornersGeorgia30092-
Research SiteChicagoIllinois60607-
Research SiteWinfieldIllinois60190-
Research SiteEvansvilleIndiana47714-
Research SiteEvansvilleIndiana47715-
Research SiteIndianapolisIndiana46260-
Research SiteAmesIowa50010-
Research SiteEl DoradoKansas67042-
Research SiteWichitaKansas67218-
Research SiteOwensboroKentucky42301-
Research SiteHammondLouisiana70403-
Research SiteKennerLouisiana70065-
Research SiteLafayetteLouisiana70508-
Research SiteLake CharlesLouisiana70601-
Research SiteShreveportLouisiana71105-
Research SiteZacharyLouisiana70791-
Research SiteAnnapolisMaryland21401-
Research SiteBaltimoreMaryland21229-
Research SiteBeltsvilleMaryland20705-
Research SitePotomacMaryland20854-
Research SiteChesterfieldMissouri63005-
Research SiteJefferson CityMissouri65109-
Research SiteKansas CityMissouri64131-
Research SiteMissoulaMontana59808-
Research SiteBuffaloNew York14217-
Research SiteRochesterNew York14609-
Research SiteThe BronxNew York10451-
Research SiteDurhamNorth Carolina27701-
Research SiteGreensboroNorth Carolina27408-
Research SiteHickoryNorth Carolina28601-
Research SiteMorgantonNorth Carolina28655-
Research SiteNew BernNorth Carolina28562-
Research SiteRaleighNorth Carolina27609-
Research SiteRocky MountNorth Carolina27804-
Research SiteSalisburyNorth Carolina28144-
Research SiteStatesvilleNorth Carolina28625-
Research SiteWilmingtonNorth Carolina28401-
Research SiteFargoNorth Dakota58104-
Research SiteBlue AshOhio45242-
Research SiteColumbusOhio43213-
Research SiteColumbusOhio43215-
Research SiteLimaOhio45805-
Research SiteCamp HillPennsylvania17011-
Research SiteHorshamPennsylvania19044-
Research SitePhiladelphiaPennsylvania19114-
Research SiteWest ChesterPennsylvania19380-
Research SiteAndersonSouth Carolina29621-
Research SiteFort MillSouth Carolina29707-
Research SiteMauldinSouth Carolina29662-
Research SiteMt. PleasantSouth Carolina29464-
Research SiteNorth CharlestonSouth Carolina29405-
Research SiteRapid CitySouth Dakota57701-
Research SiteBristolTennessee37620-
Research SiteKnoxvilleTennessee37849-
Research SiteKnoxvilleTennessee37912-
Research SiteKnoxvilleTennessee37938-
Research SiteBeaumontTexas77706-
Research SiteEl PasoTexas79902-
Research SiteHoustonTexas77043-
Research SiteHumbleTexas77338-
Research SiteIrvingTexas75061-
Research SiteKatyTexas77450-
Research SiteMesquiteTexas75149-
Research SiteParisTexas75462-
Research SiteSan AntonioTexas78229-
Research SiteSan MarcosTexas78666-
Research SiteSugar LandTexas77478-
Research SiteCharlottesvilleVirginia22911-
Research SiteHamptonVirginia23666-
Research SiteNorfolkVirginia23504-
Research SiteSuffolkVirginia23435-
Research SiteRedmondWashington98052-

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