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NCT07619118RecruitingPhase 3

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

A Phase III Randomised, Double-Blind, Parallel-Group Study to Assess the Effect of Fixed Dose Combination Laroprovstat/Rosuvastatin Compared With Rosuvastatin on Low-Density Lipoprotein Cholesterol in Patients With Hypercholesterolaemia

Source: ClinicalTrials.gov · Last updated 5 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
200 (estimated)
First submitted
26 May 2026
Start date
10 Sept 2026
Primary completion date
28 May 2027
Lead sponsor
AstraZeneca
NCT number
NCT07619118
EU CT number
2026-526258-15-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 200
  • From 10 Sept 2026 to the primary completion date, 28 May 2027
  • 44 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Uncontrolled severe hypertension

Other

  • Asian origin
  • Uncontrolled T2DM
  • Inadequately treated hypothyroidism

Who the study is looking for

  • 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

Age in the registry: 18 years to 130 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (44)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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BurwoodAustraliaNot yet recruiting
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Hope IslandAustraliaRecruiting
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Hoppers CrossingAustraliaNot yet recruiting
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WoolloongabbaAustraliaRecruiting
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CambridgeCanadaSuspended
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GuelphCanadaRecruiting
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MississaugaCanadaRecruiting
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North YorkCanadaRecruiting
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Stoney CreekCanadaRecruiting
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TorontoCanadaRecruiting
Klinische Forschung Berlin-Mitte GmbH
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BerlinGermanyRecruiting
Hausarztzentrum Bocholderstrasse
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EssenGermanyRecruiting
ClinPhenomics CVC GmbH
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Frankfurt am MainGermanyRecruiting
Medical Center- University of Freiburg
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Freiburg im BreisgauGermanyRecruiting
Klinische Forschung Hannover-Mitte GmbH
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HanoverGermanyRecruiting
Kardiopraxis Schirmer
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KaiserslauternGermanyRecruiting
Universitaetsklinikum Leipzig Aor
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LeipzigGermanyRecruiting
Centrum für Diagnostik und Gesundheit - Studienambulanz Hartard
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MünchenGermanyRecruiting
Gemeinschaftspraxis Prof. Dr. med. Jeserich/Dr. med. Malleier
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NürnbergGermanyRecruiting
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AndersonUnited StatesNot yet recruiting
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BeltsvilleUnited StatesRecruiting
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BristolUnited StatesNot yet recruiting
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ConyersUnited StatesRecruiting
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DecaturUnited StatesRecruiting
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EvansvilleUnited StatesNot yet recruiting
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FargoUnited StatesNot yet recruiting
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GardenaUnited StatesNot yet recruiting
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HoustonUnited StatesNot yet recruiting
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IndianapolisUnited StatesWithdrawn
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JacksonvilleUnited StatesNot yet recruiting
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LomitaUnited StatesNot yet recruiting
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MesquiteUnited StatesRecruiting
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Miami LakesUnited StatesRecruiting
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OrlandoUnited StatesNot yet recruiting
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Peachtree CornersUnited StatesNot yet recruiting
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Pembroke PinesUnited StatesNot yet recruiting
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PomonaUnited StatesRecruiting
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Rocky MountUnited StatesNot yet recruiting
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SacramentoUnited StatesNot yet recruiting
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StatesvilleUnited StatesNot yet recruiting
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Sugar LandUnited StatesRecruiting
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Sun City WestUnited StatesRecruiting
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WilmingtonUnited StatesNot yet recruiting
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ZacharyUnited StatesNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.