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A Phase III Study to Assess the Effect of FDC Laroprovstat/Rosuvastatin Compared With Laroprovstat, Rosuvastatin and Placebo on LDL-C in LLT-naïve Patients.
A Phase III Randomised, Double-Blind, Factorial Design Study to Assess the Effect of Fixed Dose Combination Laroprovstat/Rosuvastatin Compared With Laroprovstat, Rosuvastatin, and Placebo on Low-Density Lipoprotein Cholesterol in Lipid-Lowering Treatment-Naïve Patients
Who can join
Ages 18 to 130 · All sexes
Full eligibility criteria
Inclusion Criteria: * Participant must be ≥ 18 years of age * Participants with no clinical history of atherosclerotic cardiovascular disease (ASCVD) and a 10-year ASCVD risk estimated as low * Participants who have not received any LLT in the 3 months prior to screening Exclusion Criteria: * Asian origin. * Statin intolerance * Uncontrolled severe hypertension * Uncontrolled type 2 diabetes mellitus * Inadequately treated hypothyroidism
About the study
This is a study to evaluate the effect on LDL-C and the safety and tolerability of FDC laroprovstat/rosuvastatin in LLT-naïve patients. Laroprovstat is a small molecule that reduces the amount of LDL-C in the blood. Laroprovstat and FDC laroprovstat/rosuvastatin are being developed for the treatment of hypercholesterolaemia.
What is being tested
- Laroprovstat (drug)
- Rosuvastatin 1 (drug)
- Rosuvastatin 2 (drug)
- Laroprovstat/Rosuvastatin 1 (drug)
- Placebo to match rosuvastatin (drug)
- Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1 (drug)
Sponsor: AstraZeneca · Participants: 600 · Started: Aug 12, 2026
Contact the study team
- AstraZeneca Clinical Study Information Center · Phone: +18772409479
Official record on ClinicalTrials.gov — NCT07619131
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.