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

INTERVENTION: Product Name: Laroprovstat/Rosuvastatin FDC, Product Code:PRD13114794, Pharmaceutical Form: FILM‐COATED TABLET, Other descriptive name: , Strength: , Product Name: Laroprovstat/Rosuvastatin FDC, Product Code:PRD13114791, Pharmaceutical Form: FILM‐COATED TABLET, Other descriptive name: , Strength: , Product Name: Laroprovstat/Rosuvastatin FDC, Product Code:PRD13114792, Pharmaceutical Form: FILM‐COATED TABLET, Other descriptive name: , Strength: , Product Name: Crestor (rosuvastatin) encapsulated tablet, Product Code:PRD13942815, Pharmaceutical Form: CAPSULE, HARD, Other descriptive name: , Strength: , Product Name: Laroprovstat/Rosuvastatin Placebo 2, Product Code:N/A, Pharmaceutical Form: N/A, Other descriptive name: N/A , Strength: , Pharmaceutical form of the placebo: N/A , Product Name: Crestor (rosuvastatin) encapsulated tablet, Product Code:PRD13942814, Pharmaceutical Form: CAPSULE, HARD, Other descriptive name: , Strength: , Product Name: Crestor (rosuvastatin) encapsulated tablet, Product Code:PRD13942813, Pharmaceutical Form: CAPSULE, HARD, Other descriptive name: , Strength: , Product Name: Laroprovstat/Rosuvastatin Placebo 1, Product Code:N/A, Pharmaceutical Form: N/A, Other descriptive name: N/A , Strength: , Pharmaceutical form of the placebo: N/A , Product Name: Rosuvastatin Placebo, Product Code:N/A, Pharmaceutical Form: N/A, Other descriptive name: N/A , Strength: , Pharmaceutical form of the placebo: N/A , Product Name: Laroprovstat/Rosuvastatin FDC, Product Code:PRD13114793, Pharmaceutical Form: FILM‐COATED TABLET, Other descriptive name: , Strength: , Product Name: Crestor (rosuvastatin) encapsulated tablet, Product Code:PRD13942796, Pharmaceutical Form: CAPSULE, HARD, Other descriptive name: , Strength: CONDITION: Hypercholesterolaemia ; MedDRA version: 29.0Level: SOCClassification code: 10027433Term: Metabolism and nutrition disorders Class: 6 ; MedDRA version: 20.0Level: HLTClassification code: 10020666Term: Hyperlipidaemias NEC Class: 10027433 ; MedDRA version: 20.0Level: PTClassification code: 10020603Term: Hypercholesterolaemia Class: 100000004861 ; MedDRA version: 20.0Level: HLGTClassification code: 10013317Term: Lipid metabolism disorders Class: 10027433 Therapeutic area: Diseases [C] ‐ Nutritional and Metabolic Diseases [C18] PRIMARY OUTCOME: Main Objective: To compare the effect of treatment with FDC laroprovstat/rosuvastatin versus rosuvastatin on LDL‐C at 8 weeks Primary end point(s): Relative change in LDL‐C at 8 weeks, To compare the effect of treatment with laroprovstat/rosuvastatin versus rosuvastatin on LDL‐C at 8weeks Secondary Objective: To compare the effect of treatment with FDC laroprovstat/rosuvastatin versus rosuvastatin on Apo B at 8 weeks., To compare the effect of treatment with FDC laroprovstat/rosuvastatin versus rosuvastatin on non‐HDL‐C at 8 weeks, To compare the effect of treatment with FDC laroprovstat/rosuvastatin versus rosuvastatin on total cholesterol at 8 weeks SECONDARY OUTCOME: Secondary end point(s):Relative change in Apo B at 8 weeks, To compare the effect of treatment with laroprovstat/rosuvastatin versus rosuvastatin on Apo B at 8 weeks Secondary end point(s):Relative change in non‐HDL‐C at 8 weeks, To compare the effect of treatment with laroprovstat/rosuvastatin versus rosuvastatin on non‐HDL‐C at 8 weeks Secondary end point(s):Relative change in total cholesterol at 8 weeks, To compare the effect of treatment with laroprovstat/rosuvastatin versus rosuvastatin on total cholesterol at 8 weeks 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