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NCT Number: NCT07619131

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.

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.

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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

Primary location

Research Site, Burgas, Bulgaria

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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 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

Treatment and study plan

Laroprovstat

Drug

daily oral dose of the Laroprovstat

Rosuvastatin 1

Drug

daily oral dose of the Rosuvastatin 1

Rosuvastatin 2

Drug

daily oral dose of the Rosuvastatin 2

Laroprovstat/Rosuvastatin 1

Drug

daily oral dose of the Laroprovstat/Rosuvastatin 1

Placebo to match rosuvastatin

Drug

daily oral dose of the Placebo to match Rosuvastatin

Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1

Drug

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

Laroprovstat/Rosuvastatin 2

Drug

daily oral dose of the Laroprovstat/Rosuvastatin 2

Placebo to match Laroprovstat/Rosuvastatin 2

Drug

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

Primary outcomes

  1. Relative change in LDL-C at 8 weeks

    Time frame: 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

  2. Relative change in LDL-C at 8 weeks

    Time frame: 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 outcomes

  1. Relative change in LDL-C

    Time frame: 8 weeks

    To compare the effect of treatment with FDC laroprovstat/rosuvastatin 1 versus rosuvastatin 2 alone on LDL-C at 8 weeks

  2. Relative change in Apo B

    Time frame: 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

  3. Relative change in non-HDL-C

    Time frame: 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

  4. Relative change in total cholesterol

    Time frame: 8 weeks

    To compare the effect of treatment with FDC laroprovstat/rosuvastatin versus the individual components and placebo on total cholesterol at 8 weeks

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 1, 2026
Registry last updated
Sep 10, 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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