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Clinical Trials in the USA / NCT07619118
Recruiting Phase 3

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

NCT07619118 · tracked via the Priya Life Science USA tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2026-09-10
Last updated
2026-10-05

Condition(s) studied

Hypercholesterolaemia

Investigational drug(s) / intervention(s)

laroprovstat/rosuvastatin 1laroprovstat/rosuvastatin 2laroprovstat/rosuvastatin 3laroprovstat/rosuvastatin 4Placebo to match laroprovstat/rosuvastatin 1,2,3Placebo to match laroprovstat/rosuvastatin 4Rosuvastatin 1 →Rosuvastatin 2 →Rosuvastatin 3Rosuvastatin 4Placebo to match Rosuvastatin

laroprovstat/rosuvastatin 1: daily oral dose of the laroprovstat/rosuvastatin 1

laroprovstat/rosuvastatin 2: daily oral dose of the laroprovstat/rosuvastatin 2

laroprovstat/rosuvastatin 3: daily oral dose of the laroprovstat/rosuvastatin 3

laroprovstat/rosuvastatin 4: daily oral dose of the laroprovstat/rosuvastatin 4

Placebo to match laroprovstat/rosuvastatin 1,2,3: Daily oral dose of placebo to match FDC laroprovstat/rosuvastatin 1,2,3

Placebo to match laroprovstat/rosuvastatin 4: Daily oral dose of placebo to match FDC laroprovstat/rosuvastatin 4

Rosuvastatin 1: daily oral dose of rosuvastatin 1

Rosuvastatin 2: daily oral dose of rosuvastatin 2

Rosuvastatin 3: daily oral dose of rosuvastatin 3

Rosuvastatin 4: daily oral dose of rosuvastatin 4

Placebo to match Rosuvastatin: daily oral dose of placebo to match rosuvastatin

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (45)

FacilityCityRegionStatus
Research Site Sun City West Arizona Recruiting
Research Site Gardena California Not Yet Recruiting
Research Site Lomita California Not Yet Recruiting
Research Site Pomona California Recruiting
Research Site Sacramento California Not Yet Recruiting
Research Site Jacksonville Florida Not Yet Recruiting
Research Site Miami Lakes Florida Recruiting
Research Site Orlando Florida Not Yet Recruiting
Research Site Pembroke Pines Florida Not Yet Recruiting
Research Site Conyers Georgia Recruiting
Research Site Decatur Georgia Recruiting
Research Site Peachtree Corners Georgia Not Yet Recruiting
Research Site Evansville Indiana Not Yet Recruiting
Research Site Indianapolis Indiana Withdrawn
Research Site Zachary Louisiana Not Yet Recruiting
Research Site Beltsville Maryland Recruiting
Research Site Rocky Mount North Carolina Not Yet Recruiting
Research Site Statesville North Carolina Not Yet Recruiting
Research Site Wilmington North Carolina Not Yet Recruiting
Research Site Fargo North Dakota Not Yet Recruiting
Research Site Anderson South Carolina Not Yet Recruiting
Research Site Bristol Tennessee Not Yet Recruiting
Research Site Houston Texas Not Yet Recruiting
Research Site Houston Texas Recruiting
Research Site Mesquite Texas Recruiting
Research Site Sugar Land Texas Recruiting
Research Site Burwood Australia Not Yet Recruiting
Research Site Hope Island Australia Recruiting
Research Site Hoppers Crossing Australia Not Yet Recruiting
Research Site Woolloongabba Australia Recruiting
Research Site Cambridge Ontario Suspended
Research Site Guelph Ontario Recruiting
Research Site Mississauga Ontario Recruiting
Research Site North York Ontario Recruiting
Research Site Stoney Creek Ontario Recruiting
Research Site Toronto Ontario Recruiting
Research Site Berlin Germany Not Yet Recruiting
Research Site Essen Germany Not Yet Recruiting
Research Site Frankfurt Germany Not Yet Recruiting
Research Site Freiburg im Breisgau Germany Not Yet Recruiting

+ 5 more sites — see the full list on the official registry below.

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Other trials for the same condition

Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Cardiovascular Outcomes Study (MK-0616-015) CORALreef Outcomes Active, not recruiting
A Study to Evaluate the Pharmacodynamics of a Combination of QCZ484 and Inclisiran in Participants With Hypertension and Concomitant Hypercholesterolemia Recruiting
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. Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07619118 on ClinicalTrials.gov ↗ ← All trials in the USA