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.

NCT07619131 · tracked via the Priya Life Science UK tracker

Sponsor

AstraZeneca

Phase

Phase 3

Started

2026-08-12

Last updated

2026-09-10

Condition(s) studied

Hypercholesterolaemia

Investigational drug(s) / intervention(s)

LaroprovstatRosuvastatin 1Rosuvastatin 2Laroprovstat/Rosuvastatin 1Placebo to match rosuvastatinPlacebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1Laroprovstat/Rosuvastatin 2Placebo to match Laroprovstat/Rosuvastatin 2

Laroprovstat: daily oral dose of the Laroprovstat

Rosuvastatin 1: daily oral dose of the Rosuvastatin 1

Rosuvastatin 2: daily oral dose of the Rosuvastatin 2

Laroprovstat/Rosuvastatin 1: daily oral dose of the Laroprovstat/Rosuvastatin 1

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

Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1: daily oral dose of the Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1

Laroprovstat/Rosuvastatin 2: daily oral dose of the Laroprovstat/Rosuvastatin 2

Placebo to match Laroprovstat/Rosuvastatin 2: daily oral dose of the Placebo to match Laroprovstat/Rosuvastatin 2

Study summary

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

Sex

ALL

Min age

18 Years

Max age

130 Years

Healthy volunteers

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

Primary outcome measure(s)

Relative change in LDL-C at 8 weeks — 8 weeks
To compare the effect of treatment with FDC laroprovstat/rosuvastatin 2 versus the following on LDL-C at 8 weeks: * Placebo * Rosuvastatin 2 * Laroprovstat
Relative change in LDL-C at 8 weeks — 8 weeks
To compare the effect of treatment with FDC laroprovstat/rosuvastatin 1 versus the following on LDL-C at 8 weeks: * Placebo * Rosuvastatin 1 * Laroprovstat

Trial sites (152)

Facility	City	Region	Status
Research Site	Dothan	Alabama	Not Yet Recruiting
Research Site	Chandler	Arizona	Not Yet Recruiting
Research Site	Phoenix	Arizona	Not Yet Recruiting
Research Site	Huntington Beach	California	Not Yet Recruiting
Research Site	Loma Linda	California	Not Yet Recruiting
Research Site	Lomita	California	Not Yet Recruiting
Research Site	Long Beach	California	Not Yet Recruiting
Research Site	San Dimas	California	Not Yet Recruiting
Research Site	Arvada	Colorado	Not Yet Recruiting
Research Site	Colorado Springs	Colorado	Recruiting
Research Site	Waterbury	Connecticut	Not Yet Recruiting
Research Site	Clearwater	Florida	Not Yet Recruiting
Research Site	DeLand	Florida	Not Yet Recruiting
Research Site	Hollywood	Florida	Not Yet Recruiting
Research Site	Jacksonville	Florida	Not Yet Recruiting
Research Site	Lakeland	Florida	Recruiting
Research Site	Miami Lakes	Florida	Not Yet Recruiting
Research Site	Ocoee	Florida	Not Yet Recruiting
Research Site	Plantation	Florida	Not Yet Recruiting
Research Site	Port Orange	Florida	Not Yet Recruiting
Research Site	Tampa	Florida	Not Yet Recruiting
Research Site	Atlanta	Georgia	Not Yet Recruiting
Research Site	Conyers	Georgia	Recruiting
Research Site	Decatur	Georgia	Not Yet Recruiting
Research Site	Hinesville	Georgia	Recruiting
Research Site	Peachtree Corners	Georgia	Not Yet Recruiting
Research Site	Champaign	Illinois	Not Yet Recruiting
Research Site	Chicago	Illinois	Not Yet Recruiting
Research Site	Chicago	Illinois	Not Yet Recruiting
Research Site	Island Lake	Illinois	Not Yet Recruiting
Research Site	Melrose Park	Illinois	Not Yet Recruiting
Research Site	Palos Hills	Illinois	Not Yet Recruiting
Research Site	Evansville	Indiana	Not Yet Recruiting
Research Site	Waterloo	Iowa	Not Yet Recruiting
Research Site	Derby	Kansas	Not Yet Recruiting
Research Site	Lexington	Kentucky	Recruiting
Research Site	Louisville	Kentucky	Not Yet Recruiting
Research Site	Zachary	Louisiana	Not Yet Recruiting
Research Site	Annapolis	Maryland	Not Yet Recruiting
Research Site	Beltsville	Maryland	Not Yet Recruiting

+ 112 more sites — see the full list on the official registry below.

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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 NCT07619131 on ClinicalTrials.gov ↗ ← All trials in the UK