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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

En recrutementAccepte des participants actuellement, selon la fiche du registre.
Contacter cette étude

En bref

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…

Phase 3600 participants recherchés152 sites11 pays

Catégories

Endocrinien et métabolique100%

Enregistré dans 1 registre

Une même étude peut être enregistrée dans plusieurs registres. Nous l'affichons une seule fois et renvoyons vers chaque fiche que nous détenons.

Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

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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.

Résumé

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.

Affections

  • Hypercholesterolaemia

Éligibilité

SexeTous
Âges18 Years – 130 Years
Volontaires sainsNon

Éligibilité telle qu'elle figure dans le registre

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

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Type d'étudeInterventionnelle
PhasePhase 3
RépartitionRandomisée
Modèle d'interventionFACTORIAL
Objectif principalTREATMENT
InsuQUADRUPLE (4)
Recrutement600 participants recherchés

Promoteur et collaborateurs

  • AstraZeneca Promoteur

Groupes et interventions

  • 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

Interventions

  • Médicament Laroprovstat

    daily oral dose of the Laroprovstat

  • Médicament Laroprovstat/Rosuvastatin 1

    daily oral dose of the Laroprovstat/Rosuvastatin 1

  • Médicament Laroprovstat/Rosuvastatin 2

    daily oral dose of the Laroprovstat/Rosuvastatin 2

  • Médicament Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1

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

  • Médicament Placebo to match Laroprovstat/Rosuvastatin 2

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

  • Médicament Placebo to match rosuvastatin

    daily oral dose of the Placebo to match Rosuvastatin

  • Médicament Rosuvastatin 1

    daily oral dose of the Rosuvastatin 1

  • Médicament Rosuvastatin 2

    daily oral dose of the Rosuvastatin 2

Critères de jugement

  1. Critère de jugement 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

    Délai 8 weeks

  2. Critère de jugement 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

    Délai 8 weeks

  3. Critère de jugement secondaire

    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

    Délai 8 weeks

  4. Critère de jugement secondaire

    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

    Délai 8 weeks

  5. Critère de jugement secondaire

    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

    Délai 8 weeks

  6. Critère de jugement secondaire

    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

    Délai 8 weeks

Dates

Date de début12 août 2026 (réelle)
Achèvement principal30 juillet 2027 (estimée)
Achèvement30 juillet 2027 (estimée)
Première publication1 juin 2026 (réelle)
Dernière mise à jour10 septembre 2026
Résultats publiésNon précisé dans la fiche du registre
Statut vérifié pour la dernière foisseptembre 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

12 sites sont en recrutement

Bulgaria

ÉtablissementVilleÉtat ou régionStatut
Research SiteBurgasPas encore en recrutement
Research SitePlovdivPas encore en recrutement
Research SiteRazgradPas encore en recrutement
Research SiteSevlievoPas encore en recrutement
Research SiteSofiaPas encore en recrutement
Research SiteSofiaPas encore en recrutement
Research SiteSofiaPas encore en recrutement
Research SiteVarnaPas encore en recrutement
Research SiteVeliko TarnovoPas encore en recrutement

Canada

ÉtablissementVilleÉtat ou régionStatut
Research SiteChicoutimiQuebecPas encore en recrutement
Research SiteHamiltonOntarioEn recrutement
Research SiteScarborough VillageOntarioEn recrutement
Research SiteSherbrookeQuebecEn recrutement
Research SiteStouffvilleOntarioEn recrutement
Research SiteVictoriavilleQuebecPas encore en recrutement

Denmark

ÉtablissementVilleÉtat ou régionStatut
Research SiteAarhusPas encore en recrutement
Research SiteCopenhagenPas encore en recrutement
Research SiteGandrupPas encore en recrutement
Research SiteHerlevPas encore en recrutement
Research SiteHerningPas encore en recrutement
Research SiteSvendborgPas encore en recrutement
Research SiteVejlePas encore en recrutement
Research SiteViborgPas encore en recrutement

Germany

ÉtablissementVilleÉtat ou régionStatut
Research SiteAhrensburgPas encore en recrutement
Research SiteBerlinPas encore en recrutement
Research SiteBochumPas encore en recrutement
Research SiteGladbeckPas encore en recrutement
Research SiteHamburgPas encore en recrutement
Research SiteHanoverPas encore en recrutement
Research SiteKarlsruhePas encore en recrutement
Research SiteLeipzigPas encore en recrutement
Research SiteLöhnePas encore en recrutement
Research SiteMagdeburgPas encore en recrutement
Research SiteObertshausenPas encore en recrutement
Research SiteWiesbadenPas encore en recrutement

Hungary

ÉtablissementVilleÉtat ou régionStatut
Research SiteBudapestPas encore en recrutement
Research SiteBudapestPas encore en recrutement
Research SiteBudapestPas encore en recrutement
Research SiteKaposvárPas encore en recrutement
Research SiteZalaegerszegPas encore en recrutement

Israel

ÉtablissementVilleÉtat ou régionStatut
Research SiteHaifaPas encore en recrutement
Research SiteJerusalemPas encore en recrutement
Research SiteJerusalemPas encore en recrutement
Research SiteKfar SabaPas encore en recrutement
Research SitePetah TikvaPas encore en recrutement

Poland

ÉtablissementVilleÉtat ou régionStatut
Research SiteCzęstochowaPas encore en recrutement
Research SiteGdyniaSuspendu
Research SiteKatowicePas encore en recrutement
Research SiteLodzPas encore en recrutement
Research SiteLodzSuspendu

102 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

  1. 10 septembre 2026

    Statut modifié

    Status changed from Not yet recruiting to Recruiting

    NOT_YET_RECRUITINGRECRUITING

  2. 10 septembre 2026

    Recrutement ouvert

    Recruitment opened

    NOT_YET_RECRUITINGRECRUITING

  3. 10 septembre 2026

    Site ajouté

    152 sites added (152 total)

    0152

Registre: ClinicalTrials.gov · NCT########

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