About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Asian origin
Uncontrolled severe hypertension
Uncontrolled T2DM
Inadequately treated hypothyroidism
Trial design
Treatments tested in this trial
- laroprovstat/rosuvastatin 1
- laroprovstat/rosuvastatin 2
- laroprovstat/rosuvastatin 3
- laroprovstat/rosuvastatin 4
- Placebo to match laroprovstat/rosuvastatin 1,2,3
- Placebo to match laroprovstat/rosuvastatin 4
- Rosuvastatin 1
- Rosuvastatin 2
- Rosuvastatin 3
- Rosuvastatin 4
- Placebo to match Rosuvastatin
Treatment groups
8
Treatment groupsSee each treatment group below.