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
Study identifier:D7961C00006
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Will Be Recruiting
Official Title
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
Medical condition
Hypercholesterolemia
Phase
Phase 3
Healthy volunteers
no
Study drug
Laroprovstat, Rosuvastatin 1, Rosuvastatin 2, FDC laroprovstat/Rosuvastatin 1, FDC laroprovstat/Rosuvastatin 2, Placebo to match rosuvastatin, Placebo to match laroprovstat or FDC laroprovstat/rosuvastatin
Sex
All
Estimated Enrollment
204
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 21 Dec 2026
Estimated Primary Completion Date: 11 Oct 2027
Estimated Study Completion Date: 11 Oct 2027
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Factorial
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2026 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
No locations available
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Laroprovstat The patient will receive a daily dose of Laroprovstat. | Drug: Laroprovstat daily oral dose of the Laroprovstat Drug: Placebo to match rosuvastatin daily oral dose of the Placebo to match Rosuvastatin |
| Active Comparator: Rosuvastatin Dose 1 The patient will receive a daily dose of Rosuvastatin 1. | Drug: Rosuvastatin 1 daily oral dose of the Rosuvastatin 1 Other Name: Crestor Drug: Placebo to match laroprovstat or FDC laroprovstat/rosuvastatin daily oral dose of the Placebo to match laroprovstat or FDC laroprovstat/rosuvastatin |
| Active Comparator: Rosuvastatin Dose 2 The patient will receive a daily dose of Rosuvastatin 2. | Drug: Rosuvastatin 2 daily oral dose of the Rosuvastatin 2 Drug: Placebo to match laroprovstat or FDC laroprovstat/rosuvastatin daily oral dose of the Placebo to match laroprovstat or FDC laroprovstat/rosuvastatin |
| Experimental: FDC laroprovstat/rosuvastatin Dose combination 1 The patient will receive a daily dose of FDC Laroprovstat/Rosuvastatin 1. | Drug: FDC laroprovstat/Rosuvastatin 1 daily oral dose of the FDC Laroprovstat/Rosuvastatin 1 Drug: Placebo to match rosuvastatin daily oral dose of the Placebo to match Rosuvastatin |
| Experimental: FDC laroprovstat/rosuvastatin Dose combination 2 The patient will receive a daily dose of FDC Laroprovstat/Rosuvastatin 2. | Drug: FDC laroprovstat/Rosuvastatin 2 daily oral dose of the FDC Laroprovstat/Rosuvastatin 2 Drug: Placebo to match rosuvastatin daily oral dose of the Placebo to match Rosuvastatin |
| Placebo Comparator: Placebo The patient will receive a daily dose of Placebo. | Drug: Placebo to match rosuvastatin daily oral dose of the Placebo to match Rosuvastatin Drug: Placebo to match laroprovstat or FDC laroprovstat/rosuvastatin daily oral dose of the Placebo to match laroprovstat or FDC laroprovstat/rosuvastatin |
