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Laroprovstat

Phase 3

Hypercholesterolaemia | Small molecule | Metabolic |AstraZeneca PLC|Trials Updated: Oct 5, 2026

Laroprovstat development status

Highest phase Phase 3
Registered trials 2 across 1 sponsor since Apr 2026

Laroprovstat target and mechanism

ModalitySmall molecule

Also known as Laroprovstat Dose X STP, Laroprovstat STP

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials2
Total Enrollment800

FDA Designations

No designations recorded

Laroprovstat clinical trials

Laroprovstat · 2 trials · 1 indication

Phase 3 2
NCT07619118A Phase III Study to Assess the Effect of FDC Laroprovstat/Rosuvastatin Compared With Rosuvastatin on LDL-C in Patients With HypercholesterolaemiaHypercholesterolaemia
RECRUITING200 Analytics
NCT07619131A Phase III Study to Assess the Effect of FDC Laroprovstat/Rosuvastatin Compared With Laroprovstat, Rosuvastatin and Placebo on LDL-C in LLT-naïve Patients.Hypercholesterolaemia
RECRUITING600 Analytics
PHASE3RECRUITING
A Phase III Study to Assess the Effect of FDC Laroprovstat/Rosuvastatin Compared With Rosuvastatin on LDL-C in Patients With Hypercholesterolaemia
HypercholesterolaemiaUnlock trial analytics
PHASE3RECRUITING
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.
HypercholesterolaemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Relative change in LDL-C at 8 weeks
8 weeks

To compare the effect of treatment with laroprovstat/rosuvastatin versus rosuvastatin on LDL-C at 8 weeks

Secondary Endpoints

Relative change in Apo B at 8 weeks
8 weeks
Relative change in non-HDL-C at 8 weeks
8 weeks
Relative change in total cholesterol at 8 weeks
8 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
laroprovstat/rosuvastatin dose 1EXPERIMENTALPatient will receive a daily dose of laroprovstat/rosuvastatin 1 and a placebo to match rosuvastatin 1
rosuvastatin dose 1ACTIVE_COMPARATORPatient will receive a daily dose of rosuvastatin 1 and placebo to match laroprovstat/rosuvastatin 1
laroprovstat/rosuvastatin dose 2EXPERIMENTALPatient will receive a daily dose of laroprovstat/rosuvastatin 2 and a placebo to match rosuvastatin 2
rosuvastatin dose 2ACTIVE_COMPARATORPatient will receive a daily dose of rosuvastatin 2 and placebo to match laroprovstat/rosuvastatin 2
laroprovstat/rosuvastatin dose 3EXPERIMENTALPatient will receive a daily dose of laroprovstat/rosuvastatin 3 and a placebo to match rosuvastatin 3
rosuvastatin dose 3ACTIVE_COMPARATORPatient will receive a daily dose of rosuvastatin 3 and placebo to match laroprovstat/rosuvastatin 3
laroprovstat/rosuvastatin dose 4EXPERIMENTALPatient will receive a daily dose of laroprovstat/rosuvastatin 4 and a placebo to match rosuvastatin 4
rosuvastatin dose 4ACTIVE_COMPARATORPatient will receive a daily dose of rosuvastatin 4 and placebo to match laroprovstat/rosuvastatin 4
LaroprovstatACTIVE_COMPARATORThe patient will receive a daily dose of Laroprovstat
PlaceboPLACEBO_COMPARATORThe patient will receive a daily dose of Placebo
Laroprovstat/Rosuvastatin dose combination 1EXPERIMENTALThe patient will receive a daily dose of Laroprovstat/Rosuvastatin 1
Laroprovstat/Rosuvastatin dose combination 2EXPERIMENTALThe patient will receive a daily dose of Laroprovstat/Rosuvastatin 2

Interventions

NameTypeDescription
laroprovstat/rosuvastatin 1COMBINATION_PRODUCTdaily oral dose of the laroprovstat/rosuvastatin 1
laroprovstat/rosuvastatin 2COMBINATION_PRODUCTdaily oral dose of the laroprovstat/rosuvastatin 2
laroprovstat/rosuvastatin 3COMBINATION_PRODUCTdaily oral dose of the laroprovstat/rosuvastatin 3
laroprovstat/rosuvastatin 4COMBINATION_PRODUCTdaily oral dose of the laroprovstat/rosuvastatin 4
Placebo to match laroprovstat/rosuvastatin 1,2,3DRUGDaily oral dose of placebo to match FDC laroprovstat/rosuvastatin 1,2,3
Placebo to match laroprovstat/rosuvastatin 4DRUGDaily oral dose of placebo to match FDC laroprovstat/rosuvastatin 4
Rosuvastatin 1DRUGdaily oral dose of rosuvastatin 1
Rosuvastatin 2DRUGdaily oral dose of rosuvastatin 2
Rosuvastatin 3DRUGdaily oral dose of rosuvastatin 3
Rosuvastatin 4DRUGdaily oral dose of rosuvastatin 4
Placebo to match RosuvastatinDRUGdaily oral dose of placebo to match rosuvastatin
LaroprovstatDRUGdaily oral dose of the Laroprovstat
Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1DRUGdaily oral dose of the Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1
Placebo to match Laroprovstat/Rosuvastatin 2DRUGdaily oral dose of the Placebo to match Laroprovstat/Rosuvastatin 2
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Eligibility Criteria

Age Range18 Years to 130 Years
SexALL
Healthy VolunteersNo
Study Sites45

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 fi...

Countries:United StatesAustraliaCanadaGermanyBulgariaDenmarkHungaryIsraelPolandSpainUkraineUnited Kingdom
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Recent Changes (Last 90 Days)

LOWOct 5, 2026NCT07619118Status: NOT_YET_RECRUITING → RECRUITING
LOWOct 5, 2026NCT07619118Status: NOT_YET_RECRUITING → RECRUITING
LOWSep 10, 2026NCT07619131Status: NOT_YET_RECRUITING → RECRUITING
LOWSep 10, 2026NCT07619131Status: NOT_YET_RECRUITING → RECRUITING

Frequently asked questions about Laroprovstat

What is Laroprovstat used for?

Laroprovstat is an investigational small molecule being developed for the treatment of hypercholesterolaemia, a condition of elevated cholesterol in the blood. It is being studied both as a standalone therapy and in fixed-dose combinations with rosuvastatin and with ezetimibe, with the goal of lowering LDL-C in patients with hypercholesterolaemia.

Who is developing Laroprovstat?

Laroprovstat is being developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is running the Phase 3 clinical program evaluating laroprovstat and its fixed-dose combinations in patients with hypercholesterolaemia across multiple countries including the United States, Canada, and several European nations.

What phase is Laroprovstat in?

Laroprovstat is in Phase 3 clinical development. Two Phase 3 trials are currently recruiting, with a combined planned enrollment of 800 patients. The program includes both active-controlled and placebo-controlled designs, and the studies are randomized and double-blind, evaluating laroprovstat alone and in fixed-dose combinations.

What clinical trials is Laroprovstat in?

Laroprovstat is being evaluated in two Phase 3 trials. NCT07619131 is a 600-patient study comparing fixed-dose laroprovstat/rosuvastatin against laroprovstat, rosuvastatin, and placebo in LLT-naive patients. NCT07619118 is a 200-patient study comparing fixed-dose laroprovstat/rosuvastatin against rosuvastatin in patients with hypercholesterolaemia. Both trials are currently recruiting.