Health Trials

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.

ConditionHypercholesterolaemia
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-130
SponsorAstraZeneca

About 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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Asian origin.

Statin intolerance

Uncontrolled severe hypertension

Uncontrolled type 2 diabetes mellitus

Trial design

Treatments tested in this trial

  • Laroprovstat
  • Rosuvastatin 1
  • Rosuvastatin 2
  • Laroprovstat/Rosuvastatin 1
  • Placebo to match rosuvastatin
  • Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1
  • Laroprovstat/Rosuvastatin 2
  • Placebo to match Laroprovstat/Rosuvastatin 2

Treatment groups

600 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Locations

This trial has no locations

Sponsors and collaborators

AstraZeneca

Lead sponsor

Source ClinicalTrials.gov