A Phase III Study to Assess the Effect of FDC Laroprovstat/Rosuvastatin Compared With Rosuvastatin on LDL-C in Patients With Hypercholesterolaemia
NCT07619118 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2026-06-01
Summary
The purpose of this study is to evaluate the effect on low-density lipoprotein-cholesterol (LDL-C) and the safety and tolerability of a fixed dose combination (FDC) of laroprovstat/rosuvastatin versus rosuvastatin alone in patients with hypercholesterolaemia with either a history of a clinical atherosclerotic cardiovascular disease (ASCVD) event or at increased risk for a first clinical ASCVD event.
Conditions
- Hypercholesterolaemia
Interventions
- COMBINATION_PRODUCT
-
laroprovstat/rosuvastatin 1
daily oral dose of the laroprovstat/rosuvastatin 1
- COMBINATION_PRODUCT
-
laroprovstat/rosuvastatin 2
daily oral dose of the laroprovstat/rosuvastatin 2
- COMBINATION_PRODUCT
-
laroprovstat/rosuvastatin 3
daily oral dose of the laroprovstat/rosuvastatin 3
- COMBINATION_PRODUCT
-
laroprovstat/rosuvastatin 4
daily oral dose of the laroprovstat/rosuvastatin 4
- DRUG
-
Placebo to match laroprovstat/rosuvastatin 1,2,3
Daily oral dose of placebo to match FDC laroprovstat/rosuvastatin 1,2,3
- DRUG
-
Placebo to match laroprovstat/rosuvastatin 4
Daily oral dose of placebo to match FDC laroprovstat/rosuvastatin 4
- DRUG
-
Rosuvastatin 1
daily oral dose of rosuvastatin 1
- DRUG
-
Rosuvastatin 2
daily oral dose of rosuvastatin 2
- DRUG
-
Rosuvastatin 3
daily oral dose of rosuvastatin 3
- DRUG
-
Rosuvastatin 4
daily oral dose of rosuvastatin 4
- DRUG
-
Placebo to match Rosuvastatin
daily oral dose of placebo to match rosuvastatin
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 130 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-09-15
- Primary Completion
- 2027-05-28
- Completion
- 2027-05-28
- FDA Drug
- Yes
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