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.

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

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07619131

Enrollment

600

Registered

2026-06-01

Start date

2026-08-12

Completion date

2027-07-30

Last updated

2026-09-10

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

Conditions

Hypercholesterolaemia

Brief summary

This is a study to evaluate the effect on LDL-C and the safety and tolerability of FDC laroprovstat/rosuvastatin in LLT-naïve patients. Laroprovstat is a small molecule that reduces the amount of LDL-C in the blood. Laroprovstat and FDC laroprovstat/rosuvastatin are being developed for the treatment of hypercholesterolaemia.

Interventions

DRUGLaroprovstat

daily oral dose of the Laroprovstat

DRUGRosuvastatin 1

daily oral dose of the Rosuvastatin 1

DRUGRosuvastatin 2

daily oral dose of the Rosuvastatin 2

DRUGLaroprovstat/Rosuvastatin 1

daily oral dose of the Laroprovstat/Rosuvastatin 1

DRUGPlacebo to match rosuvastatin

daily oral dose of the Placebo to match Rosuvastatin

DRUGPlacebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1

daily oral dose of the Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1

DRUGLaroprovstat/Rosuvastatin 2

daily oral dose of the Laroprovstat/Rosuvastatin 2

DRUGPlacebo to match Laroprovstat/Rosuvastatin 2

daily oral dose of the Placebo to match Laroprovstat/Rosuvastatin 2

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

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 with no clinical history of atherosclerotic cardiovascular disease (ASCVD) and a 10-year ASCVD risk estimated as low * Participants who have not received any LLT in the 3 months prior to screening

Exclusion criteria

* Asian origin. * Statin intolerance * Uncontrolled severe hypertension * Uncontrolled type 2 diabetes mellitus * 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 FDC laroprovstat/rosuvastatin 2 versus the following on LDL-C at 8 weeks: * Placebo * Rosuvastatin 2 * Laroprovstat

Secondary

Measure	Time frame	Description
Relative change in LDL-C	8 weeks	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	8 weeks	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	8 weeks	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	8 weeks	To compare the effect of treatment with FDC laroprovstat/rosuvastatin versus the individual components and placebo on total cholesterol at 8 weeks

Countries

Bulgaria, Canada, Denmark, Germany, Hungary, Israel, Poland, Spain, Ukraine, United Kingdom, United States

Contacts

CONTACTAstraZeneca Clinical Study Information Center

information.center@astrazeneca.com+18772409479

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026