A Phase III Study to Assess the Effect of FDC Laroprovstat/Rosuvastatin Compared with Rosuvastatin on LDL-C in Patients with Hypercholesterolaemia
Study identifier:D7961C00001
ClinicalTrials.gov identifier:NCT07619118
EudraCT identifier:N/A
CTIS identifier:N/A
Will Be Recruiting
Official Title
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
Medical condition
hypercholesterolaemia
Phase
Phase 3
Healthy volunteers
no
Study drug
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
Sex
All
Estimated Enrollment
200
Study type
Interventional
Age
18 Years - 130 Years
Date
Study Start Date: 15 Sept 2026
Estimated Primary Completion Date: 28 May 2027
Estimated Study Completion Date: 28 May 2027
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 May 2026 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: laroprovstat/rosuvastatin dose 1 Patient will receive a daily dose of laroprovstat/rosuvastatin 1 and a placebo to match rosuvastatin 1 | Combination Product: laroprovstat/rosuvastatin 1 daily oral dose of the laroprovstat/rosuvastatin 1 Drug: Placebo to match Rosuvastatin daily oral dose of placebo to match rosuvastatin |
| Active Comparator: rosuvastatin dose 1 Patient will receive a daily dose of rosuvastatin 1 and placebo to match laroprovstat/rosuvastatin 1 | Drug: Placebo to match laroprovstat/rosuvastatin 1,2,3 Daily oral dose of placebo to match FDC laroprovstat/rosuvastatin 1,2,3 Drug: Rosuvastatin 1 daily oral dose of rosuvastatin 1 |
| Experimental: laroprovstat/rosuvastatin dose 2 Patient will receive a daily dose of laroprovstat/rosuvastatin 2 and a placebo to match rosuvastatin 2 | Combination Product: laroprovstat/rosuvastatin 2 daily oral dose of the laroprovstat/rosuvastatin 2 Drug: Placebo to match Rosuvastatin daily oral dose of placebo to match rosuvastatin |
| Active Comparator: rosuvastatin dose 2 Patient will receive a daily dose of rosuvastatin 2 and placebo to match laroprovstat/rosuvastatin 2 | Drug: Placebo to match laroprovstat/rosuvastatin 1,2,3 Daily oral dose of placebo to match FDC laroprovstat/rosuvastatin 1,2,3 Drug: Rosuvastatin 2 daily oral dose of rosuvastatin 2 |
| Experimental: laroprovstat/rosuvastatin dose 3 Patient will receive a daily dose of laroprovstat/rosuvastatin 3 and a placebo to match rosuvastatin 3 | Combination Product: laroprovstat/rosuvastatin 3 daily oral dose of the laroprovstat/rosuvastatin 3 Drug: Placebo to match Rosuvastatin daily oral dose of placebo to match rosuvastatin |
| Active Comparator: rosuvastatin dose 3 Patient will receive a daily dose of rosuvastatin 3 and placebo to match laroprovstat/rosuvastatin 3 | Drug: Placebo to match laroprovstat/rosuvastatin 1,2,3 Daily oral dose of placebo to match FDC laroprovstat/rosuvastatin 1,2,3 Drug: Rosuvastatin 3 daily oral dose of rosuvastatin 3 |
| Experimental: laroprovstat/rosuvastatin dose 4 Patient will receive a daily dose of laroprovstat/rosuvastatin 4 and a placebo to match rosuvastatin 4 | Combination Product: laroprovstat/rosuvastatin 4 daily oral dose of the laroprovstat/rosuvastatin 4 Drug: Placebo to match Rosuvastatin daily oral dose of placebo to match rosuvastatin |
| Active Comparator: rosuvastatin dose 4 Patient will receive a daily dose of rosuvastatin 4 and placebo to match laroprovstat/rosuvastatin 4 | Drug: Placebo to match laroprovstat/rosuvastatin 4 Daily oral dose of placebo to match FDC laroprovstat/rosuvastatin 4 Drug: Rosuvastatin 4 daily oral dose of rosuvastatin 4 |
