xMedica

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

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.
Contatta questo studio

In breve

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 partecipanti ricercati152 centri11 paesi

Categorie

Endocrino e metabolico100%

Registrato in 1 registro

Uno studio può essere registrato in più registri. Lo mostriamo una volta sola e colleghiamo ogni scheda in nostro possesso.

Le informazioni sulla sperimentazione sono mostrate così come pubblicate dal registro, nella lingua originale.

Ti interessa questo studio?

Accedi oppure crea un account per registrare il tuo interesse e seguire questo studio.

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.

Sintesi

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.

Patologie

  • Hypercholesterolaemia

Idoneità

SessoTutti
Età18 Years – 130 Years
Volontari saniNo

Idoneità come riportata nel 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

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Tipo di studioInterventistico
FaseFase 3
AssegnazioneRandomizzata
Modello di interventoFACTORIAL
Finalità principaleTREATMENT
MascheramentoQUADRUPLE (4)
Arruolamento600 partecipanti ricercati

Sponsor e collaboratori

  • AstraZeneca Sponsor

Bracci e interventi

  • 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

Interventi

  • Farmaco Laroprovstat

    daily oral dose of the Laroprovstat

  • Farmaco Laroprovstat/Rosuvastatin 1

    daily oral dose of the Laroprovstat/Rosuvastatin 1

  • Farmaco Laroprovstat/Rosuvastatin 2

    daily oral dose of the Laroprovstat/Rosuvastatin 2

  • Farmaco Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1

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

  • Farmaco Placebo to match Laroprovstat/Rosuvastatin 2

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

  • Farmaco Placebo to match rosuvastatin

    daily oral dose of the Placebo to match Rosuvastatin

  • Farmaco Rosuvastatin 1

    daily oral dose of the Rosuvastatin 1

  • Farmaco Rosuvastatin 2

    daily oral dose of the Rosuvastatin 2

Esiti misurati

  1. Esito primario

    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

    Orizzonte temporale 8 weeks

  2. Esito primario

    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

    Orizzonte temporale 8 weeks

  3. Esito secondario

    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

    Orizzonte temporale 8 weeks

  4. Esito secondario

    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

    Orizzonte temporale 8 weeks

  5. Esito secondario

    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

    Orizzonte temporale 8 weeks

  6. Esito secondario

    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

    Orizzonte temporale 8 weeks

Date

Data di inizio12 agosto 2026 (effettiva)
Conclusione primaria30 luglio 2027 (stimata)
Conclusione30 luglio 2027 (stimata)
Prima pubblicazione1 giugno 2026 (effettiva)
Ultimo aggiornamento10 settembre 2026
Risultati pubblicatiNon indicato nella scheda del registro
Stato verificato l'ultima voltasettembre 2026

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

12 centri stanno reclutando

Bulgaria

StrutturaCittàStato o regioneStato
Research SiteBurgasNon ancora in reclutamento
Research SitePlovdivNon ancora in reclutamento
Research SiteRazgradNon ancora in reclutamento
Research SiteSevlievoNon ancora in reclutamento
Research SiteSofiaNon ancora in reclutamento
Research SiteSofiaNon ancora in reclutamento
Research SiteSofiaNon ancora in reclutamento
Research SiteVarnaNon ancora in reclutamento
Research SiteVeliko TarnovoNon ancora in reclutamento

Canada

StrutturaCittàStato o regioneStato
Research SiteChicoutimiQuebecNon ancora in reclutamento
Research SiteHamiltonOntarioIn reclutamento
Research SiteScarborough VillageOntarioIn reclutamento
Research SiteSherbrookeQuebecIn reclutamento
Research SiteStouffvilleOntarioIn reclutamento
Research SiteVictoriavilleQuebecNon ancora in reclutamento

Denmark

StrutturaCittàStato o regioneStato
Research SiteAarhusNon ancora in reclutamento
Research SiteCopenhagenNon ancora in reclutamento
Research SiteGandrupNon ancora in reclutamento
Research SiteHerlevNon ancora in reclutamento
Research SiteHerningNon ancora in reclutamento
Research SiteSvendborgNon ancora in reclutamento
Research SiteVejleNon ancora in reclutamento
Research SiteViborgNon ancora in reclutamento

Germany

StrutturaCittàStato o regioneStato
Research SiteAhrensburgNon ancora in reclutamento
Research SiteBerlinNon ancora in reclutamento
Research SiteBochumNon ancora in reclutamento
Research SiteGladbeckNon ancora in reclutamento
Research SiteHamburgNon ancora in reclutamento
Research SiteHanoverNon ancora in reclutamento
Research SiteKarlsruheNon ancora in reclutamento
Research SiteLeipzigNon ancora in reclutamento
Research SiteLöhneNon ancora in reclutamento
Research SiteMagdeburgNon ancora in reclutamento
Research SiteObertshausenNon ancora in reclutamento
Research SiteWiesbadenNon ancora in reclutamento

Hungary

StrutturaCittàStato o regioneStato
Research SiteBudapestNon ancora in reclutamento
Research SiteBudapestNon ancora in reclutamento
Research SiteBudapestNon ancora in reclutamento
Research SiteKaposvárNon ancora in reclutamento
Research SiteZalaegerszegNon ancora in reclutamento

Israel

StrutturaCittàStato o regioneStato
Research SiteHaifaNon ancora in reclutamento
Research SiteJerusalemNon ancora in reclutamento
Research SiteJerusalemNon ancora in reclutamento
Research SiteKfar SabaNon ancora in reclutamento
Research SitePetah TikvaNon ancora in reclutamento

Poland

StrutturaCittàStato o regioneStato
Research SiteCzęstochowaNon ancora in reclutamento
Research SiteGdyniaSospeso
Research SiteKatowiceNon ancora in reclutamento
Research SiteLodzNon ancora in reclutamento
Research SiteLodzSospeso

Nella scheda del registro sono indicati altri 102 centri.

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

  1. 10 settembre 2026

    Stato modificato

    Status changed from Not yet recruiting to Recruiting

    NOT_YET_RECRUITINGRECRUITING

  2. 10 settembre 2026

    Reclutamento aperto

    Recruitment opened

    NOT_YET_RECRUITINGRECRUITING

  3. 10 settembre 2026

    Centro aggiunto

    152 sites added (152 total)

    0152

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

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