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

AstraZeneca · NCT07619118

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–130 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
200
US sites recruiting
9
Study start
September 10, 2026
Record last updated
October 5, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: laroprovstat/rosuvastatin 1; laroprovstat/rosuvastatin 2; laroprovstat/rosuvastatin 3; laroprovstat/rosuvastatin 4; Placebo to match laroprovstat/rosuvastatin 1,2,3; Placebo to match laroprovstat/rosuvastatin 4; Rosuvastatin 1; Rosuvastatin 2; Rosuvastatin 3; Rosuvastatin 4; Placebo to match Rosuvastatin

Conditions: Hypercholesterolaemia

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

Study contacts (from the official record)

  • AstraZeneca Clinical Study Information Center · 1-877-240-9479 · information.center@astrazeneca.com
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A Phase III Study to Assess the Effect of FDC… (NCT07619118) | Bored Studies