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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
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
Who can join
Ages 18 to 130 · All sexes
Full 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
About the study
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.
What is being tested
- laroprovstat/rosuvastatin 1 (combination product)
- laroprovstat/rosuvastatin 2 (combination product)
- laroprovstat/rosuvastatin 3 (combination product)
- laroprovstat/rosuvastatin 4 (combination product)
- Placebo to match laroprovstat/rosuvastatin 1,2,3 (drug)
- Placebo to match laroprovstat/rosuvastatin 4 (drug)
Sponsor: AstraZeneca · Participants: 200 · Started: Sep 10, 2026
Contact the study team
- AstraZeneca Clinical Study Information Center · Phone: 1-877-240-9479
Official record on ClinicalTrials.gov — NCT07619118
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Oct 6, 2026. Each study sets its own eligibility; the study team decides who can join.