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.

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2026-526258-15-00

Enrollment

Registered

2026-08-17

Start date

Unknown

Completion date

Unknown

Last updated

2026-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolaemia

Brief summary

Relative change in LDL‑C at 8 weeks, To compare the effect of treatment with laroprovstat/rosuvastatin versus rosuvastatin on LDL-C at 8weeks

Detailed description

Relative change in Apo B at 8 weeks, To compare the effect of treatment with laroprovstat/rosuvastatin versus rosuvastatin on Apo B at 8 weeks, Relative change in non‑HDL‑C at 8 weeks, To compare the effect of treatment with laroprovstat/rosuvastatin versus rosuvastatin on non-HDL-C at 8 weeks, Relative change in total cholesterol at 8 weeks, To compare the effect of treatment with laroprovstat/rosuvastatin versus rosuvastatin on total cholesterol at 8 weeks

Interventions

DRUGLaroprovstat/Rosuvastatin FDC

DRUGLaroprovstat/Rosuvastatin Placebo 1

DRUGRosuvastatin Placebo

DRUGCrestor (rosuvastatin) encapsulated tablet

DRUGLaroprovstat/Rosuvastatin Placebo 2

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Secondary

Measure	Time frame
Relative change in Apo B at 8 weeks, To compare the effect of treatment with laroprovstat/rosuvastatin versus rosuvastatin on Apo B at 8 weeks, Relative change in non‑HDL‑C at 8 weeks, To compare the effect of treatment with laroprovstat/rosuvastatin versus rosuvastatin on non-HDL-C at 8 weeks, Relative change in total cholesterol at 8 weeks, To compare the effect of treatment with laroprovstat/rosuvastatin versus rosuvastatin on total cholesterol at 8 weeks	—

Measure

Time frame

—

Primary

Measure	Time frame
Relative change in LDL‑C at 8 weeks, To compare the effect of treatment with laroprovstat/rosuvastatin versus rosuvastatin on LDL-C at 8weeks	—

Outcome results

None listed

Source: EU CTIS · Data processed: Aug 18, 2026