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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

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2026-525642-30-00
Enrollment
145
Registered
2026-10-05
Start date
Unknown
Completion date
Unknown
Last updated
2026-10-06

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 FDC laroprovstat/rosuvastatin 2 versus the following on LDL-C at 8 weeks: • Placebo • Rosuvastatin 2 • Laroprovstat, Relative change in LDL‑C at 8 weeks, To compare the effect of treatment with FDC laroprovstat/rosuvastatin 1 versus the following on LDL-C at 8 weeks: • Placebo • Rosuvastatin 1 • Laroprovstat

Detailed description

Relative change in LDL‑C, To compare the effect of treatment with FDC laroprovstat/rosuvastatin 1 versus rosuvastatin 2 alone on LDL-C at 8 weeks, Relative change in Apo B, To compare the effect of treatment with FDC laroprovstat/rosuvastatin versus the individual components and placebo on apolipoprotein B (Apo B) at 8 weeks, Relative change in non-HDL-C, To compare the effect of treatment with FDC laroprovstat/rosuvastatin versus the individual components and placebo on non-high-density lipoprotein cholesterol (non-HDL-C) at 8 weeks, Relative change in total cholesterol, To compare the effect of treatment with FDC laroprovstat/rosuvastatin versus the individual components and placebo on total cholesterol at 8 weeks

Interventions

DRUGPlacebo for Rosuvastatin
DRUGCrestor (rosuvastatin) encapsulated tablet
DRUGLaroprovstat/Rosuvastatin FDC
DRUGPlacebo for laroprovstat Placebo for laroprovstat/rosuvastatin 1
DRUGPlacebo for laroprovstat/rosuvastatin 2
DRUGAZD0780

Sponsors

AstraZeneca AB
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Relative change in LDL‑C at 8 weeks, To compare the effect of treatment with FDC laroprovstat/rosuvastatin 2 versus the following on LDL-C at 8 weeks: • Placebo • Rosuvastatin 2 • Laroprovstat, Relative change in LDL‑C at 8 weeks, To compare the effect of treatment with FDC laroprovstat/rosuvastatin 1 versus the following on LDL-C at 8 weeks: • Placebo • Rosuvastatin 1 • Laroprovstat—

Secondary

MeasureTime frame
Relative change in LDL‑C, To compare the effect of treatment with FDC laroprovstat/rosuvastatin 1 versus rosuvastatin 2 alone on LDL-C at 8 weeks, Relative change in Apo B, To compare the effect of treatment with FDC laroprovstat/rosuvastatin versus the individual components and placebo on apolipoprotein B (Apo B) at 8 weeks, Relative change in non-HDL-C, To compare the effect of treatment with FDC laroprovstat/rosuvastatin versus the individual components and placebo on non-high-density lipoprotein cholesterol (non-HDL-C) at 8 weeks, Relative change in total cholesterol, To compare the effect of treatment with FDC laroprovstat/rosuvastatin versus the individual components and placebo on total cholesterol at 8 weeks—

Outcome results

None listed

Source: EU CTIS · Data processed: Oct 7, 2026