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

AstraZeneca

Summary

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.

Eligibility

Age range: 18–130 years
Sex: All
Healthy volunteers: No

Detailed 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

Interventions

Drug
Laroprovstat
daily oral dose of the Laroprovstat
Drug
Rosuvastatin 1
daily oral dose of the Rosuvastatin 1
Drug
Rosuvastatin 2
daily oral dose of the Rosuvastatin 2
Drug
Laroprovstat/Rosuvastatin 1
daily oral dose of the Laroprovstat/Rosuvastatin 1
Drug
Placebo to match rosuvastatin
daily oral dose of the Placebo to match Rosuvastatin
Drug
Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1
daily oral dose of the Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1
Drug
Laroprovstat/Rosuvastatin 2
daily oral dose of the Laroprovstat/Rosuvastatin 2
Drug
Placebo to match Laroprovstat/Rosuvastatin 2
daily oral dose of the Placebo to match Laroprovstat/Rosuvastatin 2

Summary

Eligibility

Interventions

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