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NCT07610278ClinicalTrials.gov

A Study to Evaluate the Pharmacodynamics of a Combination of QCZ484 and Inclisiran in Participants With Hypertension and Concomitant Hypercholesterolemia

A Multicenter, Randomized, Double-blind, Factorial Design Phase 2 Study to Evaluate the Pharmacodynamics, Safety and Tolerability of HDY015 Administered as a Free Combination of QCZ484 and Inclisiran Compared to QCZ484, Inclisiran, and Placebo in Participants With Hypertension and Concomitant Hypercholesterolemia

En recrutementAccepte des participants actuellement, selon la fiche du registre.
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En bref

This is a multicenter, randomized, double-blind, factorial design Phase 2 study to evaluate the pharmacodynamics, safety and tolerability of a combination of QCZ484 and inclisiran compared to QCZ484, inclisiran, and placebo in participants with hypertension and concomitant hypercholesterolemia.

Phase 2120 participants recherchés29 sites1 pays

Catégories

Cardiovasculaire71%Endocrinien et métabolique29%

Enregistré dans 1 registre

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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 2026-05-27; recorded start 2026-05-29
  • 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 1128 other studies in this databaseCounted from the lead sponsor named in the record (Novartis Pharmaceuticals)
  • 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 rigourDEFINITIVE

A definitive-grade design for a phase 2 study, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation20/20

    Participants are randomly allocated between arms

  • Blinding13/20

    Double-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-centre8/8

    Multi-centre: 26 sites

  • Data monitoring committee7/7

    A data monitoring committee is in place

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleSMALL

A small study: 120 participants (target), run at 29 sites.

How this score is built
  • Enrolment19/40

    120 participants (target)

  • Site count17/25

    26 sites

  • Country count0/15

    Single country

  • Planned duration6/10

    Planned over about 20 months

  • Sponsor scale10/10

    Novartis Pharmaceuticals has led 1,104 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 multicenter, randomized, double-blind, factorial design Phase 2 study to evaluate the pharmacodynamics, safety and tolerability of a combination of QCZ484 and inclisiran compared to QCZ484, inclisiran, and placebo in participants with hypertension and concomitant hypercholesterolemia.

The study will last up to 12 months and has three periods: * Eligibility will be assessed during the screening period including 2 screening visits. Some eligibility criteria will be confirmed at the Baseline/Randomization visit. * Eligible participants will be randomized to receive a combination of QCZ484 and inclisiran, QCZ484, inclisiran or placebo once on Day 1 at the Baseline/Randomization visit. * Afterwards, participants will enter the safety follow-up period. Eligible participants who complete the treatment period have the option to participate in an open-label extension study instead of entering the safety follow-up period.

Affections

  • Hypercholesterolaemia

Éligibilité

SexeTous
Âges18 Years – 75 Years
Volontaires sainsNon

Éligibilité telle qu'elle figure dans le registre

Inclusion Criteria: * Males or females aged 18 to 75 years. * Diagnosis of primary hypertension. * Treatment with either no, or up to 2 antihypertensive medications at a stable dose for at least 4 weeks preceding screening. * Systolic blood pressure ≥140 and \<165 mmHg based on the mean of 3 sitting measurements based on office blood pressure monitoring. * Diagnosis of hypercholesterolemia including heterozygous familial hypercholesterolemia unable to reach LDL-C goals with a stable dose of statin treatment for at least 4 weeks prior to screening as per Investigator judgement, guidelines and local practice (if tolerated and not contraindicated) with or without bempedoic acid and with or without ezetimibe prescribed according to local guidance, at a stable dose for at least 4 weeks preceding Screening Visit 1. The following parameters must be confirmed at Screening Visit 2: * Fasting serum LDL-C ≥70 mg/dL and \<190 mg/dL using Friedewald equation. * Fasting triglyceride \<400 mg/dL. Exclusion Criteria: * Symptomatic orthostatic hypotension. * Treatment with certain medications and/or unable to comply with prohibited medications requirements. Other protocol inclusion/exclusion criteria may apply

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 2
RépartitionRandomisée
Modèle d'interventionPARALLEL
Objectif principalTREATMENT
InsuDOUBLE (2)
Recrutement120 participants recherchés

Promoteur et collaborateurs

  • Novartis Pharmaceuticals Promoteur

Groupes et interventions

  • QCZ484 + InclisiranEXPERIMENTAL

    QCZ484 + inclisiran, once on Day 1

  • QCZ484ACTIVE_COMPARATOR

    QCZ484 + inclisiran placebo, once on Day 1

  • InclisiranACTIVE_COMPARATOR

    Inclisiran + QCZ484 placebo, once on Day 1

  • PlaceboPLACEBO_COMPARATOR

    QCZ484 placebo + inclisiran placebo, once on Day 1

Interventions

  • Médicament Inclisiran

    Inclisiran once on Day 1

  • Médicament Inclisiran placebo

    Inclisiran placebo once on Day 1

  • Médicament QCZ484

    QCZ484 once on Day 1

  • Médicament QCZ484 placebo

    QCZ484 placebo once on Day 1

Critères de jugement

  1. Critère de jugement principal

    Percent change from baseline of PCSK9 levels

    Percent (%) change from baseline of PCSK9 levels for QCZ484 + Inclisiran at Month 3

    Délai Baseline and Month 3

  2. Critère de jugement principal

    Percent change from baseline of AGT levels

    Percent (%) change from baseline of AGT levels for QCZ484 + Inclisiran at Month 3

    Délai Baseline and Month 3

  3. Critère de jugement secondaire

    Change from baseline of systolic blood pressure

    Change from baseline of systolic blood pressure for QCZ484 + Inclisiran at Month 3 and 6.

    Délai Baseline, Month 3 and Month 6

  4. Critère de jugement secondaire

    Change from baseline of LDL-C levels

    Change from baseline of LDL-C levels for QCZ484 + Inclisiran at Month 3 and 6.

    Délai Baseline, Month 3 and Month 6

  5. Critère de jugement secondaire

    Number of participants with Treatment-emergent adverse event and abnormal changes in laboratory parameters, vital signs and other safety assessments

    Number of participants with treatment-emergent adverse event, abnormal changes in laboratory parameters, vital signs and other safety assessments up to Month 12.

    Délai Up to month 12

Dates

Date de début29 mai 2026 (réelle)
Achèvement principal28 avril 2027 (estimée)
Achèvement3 février 2028 (estimée)
Première publication27 mai 2026 (réelle)
Dernière mise à jour30 juillet 2026
Résultats publiésNon précisé dans la fiche du registre
Statut vérifié pour la dernière foisjuillet 2026

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

Lieux

29 sites sont en recrutement

United States

ÉtablissementVilleÉtat ou régionStatut
Flourish Medical Clinical TrialsBoca RatonFloridaEn recrutement
Clinical Research of Brandon LLCBrandonFloridaEn recrutement
East Coast ResearchCantonGeorgiaEn recrutement
Great Lakes Clinical TrialsChicagoIllinoisEn recrutement
ALL Medical Research LLCCooper CityFloridaEn recrutement
AMR MiamiCoral GablesFloridaEn recrutement
Universal Axon Clinical ResearchDoralFloridaEn recrutement
G and L Research LLCFoleyAlabamaEn recrutement
Anderson Medical ResearchFt. WashingtonMarylandEn recrutement
Synergy Group Medical LLCHoustonTexasEn recrutement
Synergy Group Medical LLCHoustonTexasEn recrutement
East Coast Institute for ResearchJacksonvilleFloridaEn recrutement
Capitol Cardiology AssociatesLanhamMarylandEn recrutement
Clinical Trials ResearchLincolnCaliforniaEn recrutement
Walker Family CareLittle RiverSouth CarolinaEn recrutement
Downtown L A Research Center IncLos AngelesCaliforniaEn recrutement
Manassas Clinical Research CenterManassasVirginiaEn recrutement
Entrust Clinical ResearchMiamiFloridaEn recrutement
Inpatient Research Clinical LLCMiami LakesFloridaEn recrutement
Inpatient Research Clinical LLCMiami LakesFloridaEn recrutement
Monroe Biomedical ResearchMonroeNorth CarolinaEn recrutement
AMR ChicagoNilesIllinoisEn recrutement
Valley Clinical TrialsNorthridgeCaliforniaEn recrutement
American Research Centers of FLPembroke PinesFloridaEn recrutement
Dominion Medical AssociatesRichmondVirginiaEn recrutement
East Coast Inst for Research LLCSaint AugustineFloridaEn recrutement
The Center for Clinical TrialsSaralandAlabamaEn recrutement
Monroe Research LlcWest MonroeLouisianaEn recrutement
Alliance for Multispecialty ResearchWichitaKansasEn recrutement

Documents de l'étude

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

Évolution au fil du temps

  1. 30 juillet 2026

    Site ajouté

    3 sites added (29 total)

    2629

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

https://xmedica.io/trials/ctgov/NCT07610278