A Phase III Study to Assess the Effect of FDC Laroprovstat/Rosuvastatin Compared With Laroprovstat, Rosuvastatin and Placebo on LDL-C in LLT-naïve Patients.

Part of paid clinical trials in Dothan, Alabama.

Sponsor
AstraZeneca
Study ID
NCT07619131
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Hypercholesterolaemia

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Laroprovstat — DRUG
    daily oral dose of the Laroprovstat
  • Rosuvastatin 1 — DRUG
    daily oral dose of the Rosuvastatin 1
  • Rosuvastatin 2 — DRUG
    daily oral dose of the Rosuvastatin 2
  • Laroprovstat/Rosuvastatin 1 — DRUG
    daily oral dose of the Laroprovstat/Rosuvastatin 1
  • Placebo to match rosuvastatin — DRUG
    daily oral dose of the Placebo to match Rosuvastatin
  • Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1 — DRUG
    daily oral dose of the Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1
  • Laroprovstat/Rosuvastatin 2 — DRUG
    daily oral dose of the Laroprovstat/Rosuvastatin 2
  • Placebo to match Laroprovstat/Rosuvastatin 2 — DRUG
    daily oral dose of the Placebo to match Laroprovstat/Rosuvastatin 2

Study Details

This is a study to evaluate the effect on LDL-C and the safety and tolerability of FDC laroprovstat/rosuvastatin in LLT-naïve patients. Laroprovstat is a small molecule that reduces the amount of LDL-C in the blood. Laroprovstat and FDC laroprovstat/rosuvastatin are being developed for the treatment of hypercholesterolaemia.

Key Dates

First listed
Jun 1, 2026
Start date
Aug 12, 2026
Status verified
Sep 2026
Primary completion
Jul 30, 2027
Completion
Jul 30, 2027

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Laroprovstat
    The patient will receive a daily dose of Laroprovstat
  • Placebo Comparator: Placebo
    The patient will receive a daily dose of Placebo
  • Experimental: Laroprovstat/Rosuvastatin dose combination 1
    The patient will receive a daily dose of Laroprovstat/Rosuvastatin 1
  • Experimental: Laroprovstat/Rosuvastatin dose combination 2
    The patient will receive a daily dose of Laroprovstat/Rosuvastatin 2
  • Active Comparator: Rosuvastatin dose 1
    The patient will receive a daily dose of Rosuvastatin 1
  • Active Comparator: Rosuvastatin dose 2
    The patient will receive a daily dose of Rosuvastatin 2

Primary Outcome Measure

Relative change in LDL-C at 8 weeks [ Time Frame: 8 weeks ]

Central Contacts

Locations (77)

FacilityCityStateZIPSite coordinators
Research SiteDothanAlabama36305-
Research SiteChandlerArizona85225-
Research SitePhoenixArizona85053-
Research SiteHuntington BeachCalifornia92647-
Research SiteLoma LindaCalifornia92354-
Research SiteLomitaCalifornia90717-
Research SiteLong BeachCalifornia90815-
Research SiteSan DimasCalifornia91773-
Research SiteArvadaColorado80002-
Research SiteColorado SpringsColorado80909-
Research SiteWaterburyConnecticut06708-
Research SiteClearwaterFlorida33765-
Research SiteDeLandFlorida32720-
Research SiteHollywoodFlorida33021-
Research SiteJacksonvilleFlorida32209-
Research SiteLakelandFlorida33813-
Research SiteMiami LakesFlorida33016-
Research SiteOcoeeFlorida34761-
Research SitePlantationFlorida33324-
Research SitePort OrangeFlorida32127-
Research SiteTampaFlorida33606-
Research SiteAtlantaGeorgia30303-
Research SiteConyersGeorgia30094-
Research SiteDecaturGeorgia30030-
Research SiteHinesvilleGeorgia31313-
Research SitePeachtree CornersGeorgia30092-
Research SiteChampaignIllinois61822-
Research SiteChicagoIllinois60607-
Research SiteChicagoIllinois60640-
Research SiteIsland LakeIllinois60042-
Research SiteMelrose ParkIllinois60160-
Research SitePalos HillsIllinois60465-
Research SiteEvansvilleIndiana47714-
Research SiteWaterlooIowa50701-
Research SiteDerbyKansas67037-
Research SiteLexingtonKentucky40503-
Research SiteLouisvilleKentucky40205-
Research SiteZacharyLouisiana70791-
Research SiteAnnapolisMaryland21401-
Research SiteBeltsvilleMaryland20705-
Research SiteBowieMaryland20715-
Research SiteLutherville-TimoniumMaryland21093-
Research SiteOxon HillMaryland20745-
Research SiteFlintMichigan48503-
Research SiteTroyMichigan48098-
Research SiteKansas CityMissouri64108-
Research SiteSt LouisMissouri63110-
Research SiteSt LouisMissouri63136-
Research SiteMillvilleNew Jersey08332-
Research SiteAstoriaNew York11106-
Research SiteBrooklynNew York11201-
Research SiteBrooklynNew York11220-
Research SiteThe BronxNew York10455-
Research SiteDurhamNorth Carolina27705-
Research SiteMorehead CityNorth Carolina28557-
Research SiteStatesvilleNorth Carolina28625-
Research SiteWilmingtonNorth Carolina28401-
Research SiteWinston-SalemNorth Carolina27157-
Research SiteColumbusOhio43213-
Research SiteDaytonOhio45424-
Research SiteTulsaOklahoma74137-
Research SitePortlandOregon97223-
Research SiteNewportPennsylvania17074-
Research SiteSmithfieldPennsylvania15478-
Research SiteAndersonSouth Carolina29621-
Research SiteKnoxvilleTennessee37938-
Research SiteHoustonTexas77002-
Research SiteHoustonTexas77087-
Research SiteHoustonTexas77099-
Research SiteSan AntonioTexas78231-
Research SiteTomballTexas77375-
Research SiteVictoriaTexas77901-
Research SiteLaytonUtah84041-
Research SiteSalt Lake CityUtah84109-
Research SiteSouth JordanUtah84095-
Research SiteRichmondVirginia23219-
Research SiteRedmondWashington98052-

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