Search > High Cholesterol
600 Participants NeededMy employer runs this trial

Laroprovstat + Rosuvastatin for High Cholesterol

Recruiting at 131 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: AstraZeneca
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for adults 18 or older with high cholesterol who have not taken any cholesterol-lowering treatments in the past 3 months and do not have a history of heart or blood vessel disease. Only those at low risk for future heart problems can join.

Inclusion Criteria

I am 18 years old or older.
I have no history of heart or blood vessel disease and my 10-year risk is low.
I have not taken lipid-lowering therapy in the past 3 months.

Exclusion Criteria

I do not have uncontrolled severe high blood pressure.
Asian origin
Statin intolerance
See 2 more

What Are the Treatments Tested in This Trial?

Interventions

  • Laroprovstat
  • Rosuvastatin

Trial Overview

The study compares a new combination pill (laroprovstat/rosuvastatin) to each drug alone and to placebo, to see how well they lower bad cholesterol (LDL-C) in people new to treatment. Participants are randomly assigned different treatments.

How Is the Trial Designed?

6

Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Laroprovstat/Rosuvastatin dose combination 2Experimental Treatment3 Interventions
Group II: Laroprovstat/Rosuvastatin dose combination 1Experimental Treatment3 Interventions
Group III: Rosuvastatin dose 2Active Control3 Interventions
Group IV: LaroprovstatActive Control3 Interventions
Group V: Rosuvastatin dose 1Active Control3 Interventions
Group VI: PlaceboPlacebo Group3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

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