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A Phase III Study to Assess the Effect of FDC Laroprovstat/Rosuvastatin Compared With Rosuvastatin on LDL-C in Patients With Hypercholesterolaemia

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened Trial sites expanded: 0 → 45 locations · Start date changed from estimate of Sep 15, 2026 to Sep 10, 2026 · Interventions: Placebo to match Rosuvastatin (Drug), Placebo to match laroprovstat/rosuvastatin 1,2,3 (Drug), Placebo to match laroprovstat/rosuvastatin 4… to Placebo to match Rosuvastatin (Drug), Placebo to match laroprovstat/rosuvastatin 1,2,3 (Drug), Placebo to match laroprovstat/rosuvastatin 4… · 2 more Show 5 more changesShow less
    • Trial sites expanded: 0 → 45 locations
    • Start date changed from estimate of Sep 15, 2026 to Sep 10, 2026
    • Interventions: Placebo to match Rosuvastatin (Drug), Placebo to match laroprovstat/rosuvastatin 1,2,3 (Drug), Placebo to match laroprovstat/rosuvastatin 4… to Placebo to match Rosuvastatin (Drug), Placebo to match laroprovstat/rosuvastatin 1,2,3 (Drug), Placebo to match laroprovstat/rosuvastatin 4…
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 3 of 3 entries
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
AstraZeneca
727 trials monitored
See 61 trials at risk
The purpose of this study is to evaluate the effect on low-density lipoprotein-cholesterol (LDL-C) and the safety and tolerability of a fixed dose combination (FDC) of laroprovstat/rosuvastatin versus rosuvastatin alone in patients with hypercholesterolaemia with either a history of a clinical atherosclerotic cardiovascular disease (ASCVD) event or at increased risk for a first clinical ASCVD event.
Trial Details
NCT Number NCT07619118
Lead Sponsor AstraZeneca
Conditions Hypercholesterolaemia
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov