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:D7961C00002
ClinicalTrials.gov identifier:NCT07619131
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
hypercholesterolaemia
Phase
Phase 3
Healthy volunteers
no
Study drug
Laroprovstat, Rosuvastatin 1, Rosuvastatin 2, Laroprovstat/Rosuvastatin 1, Placebo to match rosuvastatin, Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1, Laroprovstat/Rosuvastatin 2, Placebo to match Laroprovstat/Rosuvastatin 2
Sex
All
Estimated Enrollment
600
Study type
Interventional
Age
18 Years - 130 Years
Date
Study Start Date: 17 Aug 2026
Estimated Primary Completion Date: 30 Jul 2027
Estimated Study Completion Date: 30 Jul 2027
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Factorial
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 May 2026 by Intrasphere
Sponsors
Intrasphere
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 Drug: Placebo to match Laroprovstat/Rosuvastatin 2 daily oral dose of the Placebo to match Laroprovstat/Rosuvastatin 2 |
| 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 and Laroprovstat/Rosuvastatin 1 daily oral dose of the Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1 Drug: Placebo to match Laroprovstat/Rosuvastatin 2 daily oral dose of the Placebo to match Laroprovstat/Rosuvastatin 2 |
| Experimental: Laroprovstat/Rosuvastatin dose combination 1 The patient will receive a daily dose of Laroprovstat/Rosuvastatin 1 | 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/Rosuvastatin 2 daily oral dose of the Placebo to match Laroprovstat/Rosuvastatin 2 |
| Experimental: Laroprovstat/Rosuvastatin dose combination 2 The patient will receive a daily dose of Laroprovstat/Rosuvastatin 2 | 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 |
| 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 Drug: Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1 daily oral dose of the Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1 Drug: Placebo to match Laroprovstat/Rosuvastatin 2 daily oral dose of the Placebo to match Laroprovstat/Rosuvastatin 2 |
| 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 and Laroprovstat/Rosuvastatin 1 daily oral dose of the Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1 Drug: Placebo to match Laroprovstat/Rosuvastatin 2 daily oral dose of the Placebo to match Laroprovstat/Rosuvastatin 2 |
