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NCT Number: NCT07619118

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

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.

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Key information

Conditions

Hypercholesterolaemia Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–130 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laroprovstat/rosuvastatin 1

Combination Product

daily oral dose of the laroprovstat/rosuvastatin 1

laroprovstat/rosuvastatin 2

Combination Product

daily oral dose of the laroprovstat/rosuvastatin 2

laroprovstat/rosuvastatin 3

Combination Product

daily oral dose of the laroprovstat/rosuvastatin 3

laroprovstat/rosuvastatin 4

Combination Product

daily oral dose of the laroprovstat/rosuvastatin 4

Placebo to match laroprovstat/rosuvastatin 1,2,3

Drug

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

Placebo to match laroprovstat/rosuvastatin 4

Drug

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

Rosuvastatin 1

Drug

daily oral dose of rosuvastatin 1

Rosuvastatin 2

Drug

daily oral dose of rosuvastatin 2

Rosuvastatin 3

Drug

daily oral dose of rosuvastatin 3

Rosuvastatin 4

Drug

daily oral dose of rosuvastatin 4

Placebo to match rosuvastatin

Drug

daily oral dose of placebo to match rosuvastatin

Primary outcomes

  1. Relative change in LDL-C at 8 weeks

    Time frame: 8 weeks

    To compare the effect of treatment with laroprovstat/rosuvastatin versus rosuvastatin on LDL-C at 8 weeks

Secondary outcomes

  1. Relative change in Apo B at 8 weeks

    Time frame: 8 weeks

    To compare the effect of treatment with laroprovstat/rosuvastatin versus rosuvastatin on Apo B at 8 weeks

  2. Relative change in non-HDL-C at 8 weeks

    Time frame: 8 weeks

    To compare the effect of treatment with laroprovstat/rosuvastatin versus rosuvastatin on non-HDL-C at 8 weeks

  3. Relative change in total cholesterol at 8 weeks

    Time frame: 8 weeks

    To compare the effect of treatment with laroprovstat/rosuvastatin versus rosuvastatin on total cholesterol at 8 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 1, 2026
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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