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

A Phase III Randomised, Double-Blind, Parallel-Group Study to Assess the Effect of Fixed Dose Combination Laroprovstat/Rosuvastatin Compared With Rosuvastatin on Low-Density Lipoprotein Cholesterol in Patients With Hypercholesterolaemia

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.

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