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NCT07619131ClinicalTrials.gov

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.

A Phase III Randomised, Double-Blind, Factorial Design Study to Assess the Effect of Fixed Dose Combination Laroprovstat/Rosuvastatin Compared With Laroprovstat, Rosuvastatin, and Placebo on Low-Density Lipoprotein Cholesterol in Lipid-Lowering Treatment-Naïve Patients

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En resumen

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…

Fase 3600 participantes buscados152 centros11 países

Categorías

Endocrino y metabólico100%

Registrado en 1 registro

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La información del ensayo se muestra tal como la publicó el registro, en su idioma original.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered before enrolment beganFirst posted 2026-06-01; recorded start 2026-08-12
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are randomly assignedAllocation is recorded as randomised
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Uses blinding (masking)A masking level is recorded in the record
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 1019 other studies in this databaseCounted from the lead sponsor named in the record (AstraZeneca)
  • Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
  • The record lists 1 condition.
  • Lead sponsor type recorded as: industry.
  • Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourSTRONG

A strong methodological design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation20/20

    Participants are randomly allocated between arms

  • Blinding20/20

    Quadruple-blind

  • Control arm15/15

    Active-comparator control arm

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type3/10

    Surrogate or intermediate endpoint (conservative default)

  • Multi-centre0/8

    Single site, or site count not stated

  • Data monitoring committee0/7

    No data monitoring committee stated

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleMEDIUM

A medium-sized study, international in scope: 600 participants (target), run at 152 sites, across 11 countries.

How this score is built
  • Enrolment27/40

    600 participants (target)

  • Site count0/25

    Site count not stated in the record

  • Country count0/15

    Country count not stated in the record

  • Planned duration5/10

    Planned over about 12 months

  • Sponsor scale10/10

    AstraZeneca has led 1,005 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Resumen

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.

Afecciones

  • Hypercholesterolaemia

Elegibilidad

SexoTodos
Edades18 Years – 130 Years
Voluntarios sanosNo

Elegibilidad tal como figura en el registro

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

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Tipo de estudioDe intervención
FaseFase 3
AsignaciónAleatorizado
Modelo de intervenciónFACTORIAL
Propósito principalTREATMENT
EnmascaramientoQUADRUPLE (4)
Inscripción600 participantes buscados

Patrocinador y colaboradores

  • AstraZeneca Patrocinador

Grupos e intervenciones

  • LaroprovstatACTIVE_COMPARATOR

    The patient will receive a daily dose of Laroprovstat

  • PlaceboPLACEBO_COMPARATOR

    The patient will receive a daily dose of Placebo

  • Laroprovstat/Rosuvastatin dose combination 1EXPERIMENTAL

    The patient will receive a daily dose of Laroprovstat/Rosuvastatin 1

  • Laroprovstat/Rosuvastatin dose combination 2EXPERIMENTAL

    The patient will receive a daily dose of Laroprovstat/Rosuvastatin 2

  • Rosuvastatin dose 1ACTIVE_COMPARATOR

    The patient will receive a daily dose of Rosuvastatin 1

  • Rosuvastatin dose 2ACTIVE_COMPARATOR

    The patient will receive a daily dose of Rosuvastatin 2

Intervenciones

  • Fármaco Laroprovstat

    daily oral dose of the Laroprovstat

  • Fármaco Laroprovstat/Rosuvastatin 1

    daily oral dose of the Laroprovstat/Rosuvastatin 1

  • Fármaco Laroprovstat/Rosuvastatin 2

    daily oral dose of the Laroprovstat/Rosuvastatin 2

  • Fármaco Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1

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

  • Fármaco Placebo to match Laroprovstat/Rosuvastatin 2

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

  • Fármaco Placebo to match rosuvastatin

    daily oral dose of the Placebo to match Rosuvastatin

  • Fármaco Rosuvastatin 1

    daily oral dose of the Rosuvastatin 1

  • Fármaco Rosuvastatin 2

    daily oral dose of the Rosuvastatin 2

Variables de resultado

  1. Variable de resultado principal

    Relative change in LDL-C at 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

    Plazo 8 weeks

  2. Variable de resultado principal

    Relative change in LDL-C at 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

    Plazo 8 weeks

  3. Variable de resultado secundaria

    Relative change in LDL-C

    To compare the effect of treatment with FDC laroprovstat/rosuvastatin 1 versus rosuvastatin 2 alone on LDL-C at 8 weeks

    Plazo 8 weeks

  4. Variable de resultado secundaria

    Relative change in Apo B

    To compare the effect of treatment with FDC laroprovstat/rosuvastatin versus the individual components and placebo on apolipoprotein B (Apo B) at 8 weeks

    Plazo 8 weeks

  5. Variable de resultado secundaria

    Relative change in non-HDL-C

    To compare the effect of treatment with FDC laroprovstat/rosuvastatin versus the individual components and placebo on non-high-density lipoprotein cholesterol (non-HDL-C) at 8 weeks

    Plazo 8 weeks

  6. Variable de resultado secundaria

    Relative change in total cholesterol

    To compare the effect of treatment with FDC laroprovstat/rosuvastatin versus the individual components and placebo on total cholesterol at 8 weeks

    Plazo 8 weeks

Fechas

Fecha de inicio12 de agosto de 2026 (real)
Finalización principal30 de julio de 2027 (estimada)
Finalización30 de julio de 2027 (estimada)
Primera publicación1 de junio de 2026 (real)
Última actualización10 de septiembre de 2026
Resultados publicadosNo indicado en el registro
Estado verificado por última vezseptiembre de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

12 centros están en reclutamiento

Bulgaria

CentroCiudadEstado o regiónEstado
Research SiteBurgasAún no recluta
Research SitePlovdivAún no recluta
Research SiteRazgradAún no recluta
Research SiteSevlievoAún no recluta
Research SiteSofiaAún no recluta
Research SiteSofiaAún no recluta
Research SiteSofiaAún no recluta
Research SiteVarnaAún no recluta
Research SiteVeliko TarnovoAún no recluta

Canada

CentroCiudadEstado o regiónEstado
Research SiteChicoutimiQuebecAún no recluta
Research SiteHamiltonOntarioEn reclutamiento
Research SiteScarborough VillageOntarioEn reclutamiento
Research SiteSherbrookeQuebecEn reclutamiento
Research SiteStouffvilleOntarioEn reclutamiento
Research SiteVictoriavilleQuebecAún no recluta

Denmark

CentroCiudadEstado o regiónEstado
Research SiteAarhusAún no recluta
Research SiteCopenhagenAún no recluta
Research SiteGandrupAún no recluta
Research SiteHerlevAún no recluta
Research SiteHerningAún no recluta
Research SiteSvendborgAún no recluta
Research SiteVejleAún no recluta
Research SiteViborgAún no recluta

Germany

CentroCiudadEstado o regiónEstado
Research SiteAhrensburgAún no recluta
Research SiteBerlinAún no recluta
Research SiteBochumAún no recluta
Research SiteGladbeckAún no recluta
Research SiteHamburgAún no recluta
Research SiteHanoverAún no recluta
Research SiteKarlsruheAún no recluta
Research SiteLeipzigAún no recluta
Research SiteLöhneAún no recluta
Research SiteMagdeburgAún no recluta
Research SiteObertshausenAún no recluta
Research SiteWiesbadenAún no recluta

Hungary

CentroCiudadEstado o regiónEstado
Research SiteBudapestAún no recluta
Research SiteBudapestAún no recluta
Research SiteBudapestAún no recluta
Research SiteKaposvárAún no recluta
Research SiteZalaegerszegAún no recluta

Israel

CentroCiudadEstado o regiónEstado
Research SiteHaifaAún no recluta
Research SiteJerusalemAún no recluta
Research SiteJerusalemAún no recluta
Research SiteKfar SabaAún no recluta
Research SitePetah TikvaAún no recluta

Poland

CentroCiudadEstado o regiónEstado
Research SiteCzęstochowaAún no recluta
Research SiteGdyniaSuspendido
Research SiteKatowiceAún no recluta
Research SiteLodzAún no recluta
Research SiteLodzSuspendido

En el registro figuran 102 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

  1. 10 de septiembre de 2026

    Estado modificado

    Status changed from Not yet recruiting to Recruiting

    NOT_YET_RECRUITINGRECRUITING

  2. 10 de septiembre de 2026

    Reclutamiento abierto

    Recruitment opened

    NOT_YET_RECRUITINGRECRUITING

  3. 10 de septiembre de 2026

    Centro añadido

    152 sites added (152 total)

    0152

Registro: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT07619131