A Phase III Study to Assess the Effect of FDC Laroprovstat/Rosuvastatin Compared With Rosuvastatin on LDL-C in Patients With Hypercholesterolaemia

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

ClinicalTrials.gov

Registry ID

NCT07619118

Enrollment

200

Registered

2026-06-01

Start date

2026-09-15

Completion date

2027-05-28

Last updated

2026-06-01

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

Conditions

Hypercholesterolaemia

Keywords

Hypercholesterolaemia

Brief 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.

Interventions

COMBINATION_PRODUCTlaroprovstat/rosuvastatin 1

daily oral dose of the laroprovstat/rosuvastatin 1

COMBINATION_PRODUCTlaroprovstat/rosuvastatin 2

daily oral dose of the laroprovstat/rosuvastatin 2

COMBINATION_PRODUCTlaroprovstat/rosuvastatin 3

daily oral dose of the laroprovstat/rosuvastatin 3

COMBINATION_PRODUCTlaroprovstat/rosuvastatin 4

daily oral dose of the laroprovstat/rosuvastatin 4

DRUGPlacebo to match laroprovstat/rosuvastatin 1,2,3

Daily oral dose of placebo to match FDC laroprovstat/rosuvastatin 1,2,3

DRUGPlacebo to match laroprovstat/rosuvastatin 4

Daily oral dose of placebo to match FDC laroprovstat/rosuvastatin 4

DRUGRosuvastatin 1

daily oral dose of rosuvastatin 1

DRUGRosuvastatin 2

daily oral dose of rosuvastatin 2

DRUGRosuvastatin 3

daily oral dose of rosuvastatin 3

DRUGRosuvastatin 4

daily oral dose of rosuvastatin 4

DRUGPlacebo to match Rosuvastatin

daily oral dose of placebo to match rosuvastatin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 130 Years

Healthy volunteers

Inclusion criteria

* Participant must be ≥ 18 years of age * Participants must be on a stable dose of all background LLTs * The stable statin dose should be judged as their maximally tolerated dose * Participants should have either history of a clinical ASCVD event or be at increased risk for a first clinical ASCVD event

Exclusion criteria

* Asian origin * Uncontrolled severe hypertension * Uncontrolled T2DM * Inadequately treated hypothyroidism

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Relative change in Apo B at 8 weeks	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	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	8 weeks	To compare the effect of treatment with laroprovstat/rosuvastatin versus rosuvastatin on total cholesterol at 8 weeks

Contacts

CONTACTAstraZeneca Clinical Study Information Center

information.center@astrazeneca.com1-877-240-9479

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 2, 2026