RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: AstraZeneca • ClinicalTrials.gov ID: NCT07619118

Registry updated: 2026-10-05

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Description

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.

Interventions

laroprovstat/rosuvastatin 1 (Combination product)
daily oral dose of the laroprovstat/rosuvastatin 1
laroprovstat/rosuvastatin 2 (Combination product)
daily oral dose of the laroprovstat/rosuvastatin 2
laroprovstat/rosuvastatin 3 (Combination product)
daily oral dose of the laroprovstat/rosuvastatin 3
laroprovstat/rosuvastatin 4 (Combination product)
daily oral dose of the laroprovstat/rosuvastatin 4
Placebo to match laroprovstat/rosuvastatin 1,2,3 (Drug)
Daily oral dose of placebo to match FDC laroprovstat/rosuvastatin 1,2,3
Placebo to match laroprovstat/rosuvastatin 4 (Drug)
Daily oral dose of placebo to match FDC laroprovstat/rosuvastatin 4
Rosuvastatin 1 (Drug)
daily oral dose of rosuvastatin 1
Rosuvastatin 2 (Drug)
daily oral dose of rosuvastatin 2
Rosuvastatin 3 (Drug)
daily oral dose of rosuvastatin 3
Rosuvastatin 4 (Drug)
daily oral dose of rosuvastatin 4
Placebo to match Rosuvastatin (Drug)
daily oral dose of placebo to match rosuvastatin

Eligibility criteria

Inclusion Criteria: * Participant must be ≥ 18 years of age * Participants must be on a stable dose of all background LLTs * The stable statin dose should be judged as their maximally tolerated dose * Participants should have either history of a clinical ASCVD event or be at increased risk for a first clinical ASCVD event Exclusion Criteria: * Asian origin * Uncontrolled severe hypertension * Uncontrolled T2DM * Inadequately treated hypothyroidism

Conditions

Hypercholesterolaemia

Locations

Research Site — Sun City West, Arizona, United States
Research Site — Gardena, California, United States
Research Site — Lomita, California, United States
Research Site — Pomona, California, United States
Research Site — Sacramento, California, United States
Research Site — Jacksonville, Florida, United States
Research Site — Miami Lakes, Florida, United States
Research Site — Orlando, Florida, United States
Research Site — Pembroke Pines, Florida, United States
Research Site — Conyers, Georgia, United States
Research Site — Decatur, Georgia, United States
Research Site — Peachtree Corners, Georgia, United States
Research Site — Evansville, Indiana, United States
Research Site — Indianapolis, Indiana, United States
Research Site — Zachary, Louisiana, United States
Research Site — Beltsville, Maryland, United States
Research Site — Rocky Mount, North Carolina, United States
Research Site — Statesville, North Carolina, United States
Research Site — Wilmington, North Carolina, United States
Research Site — Fargo, North Dakota, United States
Research Site — Anderson, South Carolina, United States
Research Site — Bristol, Tennessee, United States
Research Site — Houston, Texas, United States
Research Site — Houston, Texas, United States
Research Site — Mesquite, Texas, United States
Research Site — Sugar Land, Texas, United States
Research Site — Burwood, Australia
Research Site — Hope Island, Australia
Research Site — Hoppers Crossing, Australia
Research Site — Woolloongabba, Australia
Research Site — Cambridge, Ontario, Canada
Research Site — Guelph, Ontario, Canada
Research Site — Mississauga, Ontario, Canada
Research Site — North York, Ontario, Canada
Research Site — Stoney Creek, Ontario, Canada
Research Site — Toronto, Ontario, Canada
Research Site — Berlin, Germany
Research Site — Essen, Germany
Research Site — Frankfurt, Germany
Research Site — Freiburg im Breisgau, Germany
Research Site — Hanover, Germany
Research Site — Kaiserslautern, Germany
Research Site — Leipzig, Germany
Research Site — Munich, Germany
Research Site — Nuremberg, Germany

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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