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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 130 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Laroprovstat 		The patient will receive a daily dose of Laroprovstat
  • Drug: Laroprovstat
    daily oral dose of the Laroprovstat
  • Drug: Laroprovstat/Rosuvastatin 1
    daily oral dose of the Laroprovstat/Rosuvastatin 1
  • Drug: Placebo to match rosuvastatin
    daily oral dose of the Placebo to match Rosuvastatin
  • Drug: Laroprovstat/Rosuvastatin 2
    daily oral dose of the Laroprovstat/Rosuvastatin 2
  • Drug: Placebo to match Laroprovstat/Rosuvastatin 2
    daily oral dose of the Placebo to match Laroprovstat/Rosuvastatin 2
Placebo Comparator
Placebo 		The patient will receive a daily dose of Placebo
  • Drug: Placebo to match rosuvastatin
    daily oral dose of the Placebo to match Rosuvastatin
  • Drug: Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1
    daily oral dose of the Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1
  • Drug: Placebo to match Laroprovstat/Rosuvastatin 2
    daily oral dose of the Placebo to match Laroprovstat/Rosuvastatin 2
Experimental
Laroprovstat/Rosuvastatin dose combination 1 		The patient will receive a daily dose of Laroprovstat/Rosuvastatin 1
  • Drug: Laroprovstat/Rosuvastatin 1
    daily oral dose of the Laroprovstat/Rosuvastatin 1
  • Drug: Placebo to match rosuvastatin
    daily oral dose of the Placebo to match Rosuvastatin
  • Drug: Placebo to match Laroprovstat/Rosuvastatin 2
    daily oral dose of the Placebo to match Laroprovstat/Rosuvastatin 2
Experimental
Laroprovstat/Rosuvastatin dose combination 2 		The patient will receive a daily dose of Laroprovstat/Rosuvastatin 2
  • Drug: Placebo to match rosuvastatin
    daily oral dose of the Placebo to match Rosuvastatin
  • Drug: Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1
    daily oral dose of the Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1
  • Drug: Laroprovstat/Rosuvastatin 2
    daily oral dose of the Laroprovstat/Rosuvastatin 2
Active Comparator
Rosuvastatin dose 1 		The patient will receive a daily dose of Rosuvastatin 1
  • Drug: Rosuvastatin 1
    daily oral dose of the Rosuvastatin 1
  • Drug: Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1
    daily oral dose of the Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1
  • Drug: Placebo to match Laroprovstat/Rosuvastatin 2
    daily oral dose of the Placebo to match Laroprovstat/Rosuvastatin 2
Active Comparator
Rosuvastatin dose 2 		The patient will receive a daily dose of Rosuvastatin 2
  • Drug: Rosuvastatin 2
    daily oral dose of the Rosuvastatin 2
  • Drug: Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1
    daily oral dose of the Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1
  • Drug: Placebo to match Laroprovstat/Rosuvastatin 2
    daily oral dose of the Placebo to match Laroprovstat/Rosuvastatin 2

Recruiting Locations

Research Site
Colorado Springs, Colorado 80909

Research Site
Lakeland, Florida 33813

Research Site
Conyers, Georgia 30094

Research Site
Hinesville, Georgia 31313

Research Site
Lexington, Kentucky 40503

Research Site
Millville, New Jersey 08332

Research Site
Salt Lake City, Utah 84109

Research Site
South Jordan, Utah 84095

More Details

Status
Recruiting
Sponsor
AstraZeneca

Study Contact

AstraZeneca Clinical Study Information Center
+18772409479
information.center@astrazeneca.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.