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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

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.
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In breve

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.

Fase 2120 partecipanti ricercati29 centri1 paese

Categorie

Cardiovascolare71%Endocrino e metabolico29%

Registrato in 1 registro

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

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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.

Sintesi

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.

Patologie

  • Hypercholesterolaemia

Idoneità

SessoTutti
Età18 Years – 75 Years
Volontari saniNo

Idoneità come riportata nel registro

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

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 2
AssegnazioneRandomizzata
Modello di interventoPARALLEL
Finalità principaleTREATMENT
MascheramentoDOUBLE (2)
Arruolamento120 partecipanti ricercati

Sponsor e collaboratori

  • Novartis Pharmaceuticals Sponsor

Bracci e interventi

  • 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

Interventi

  • Farmaco Inclisiran

    Inclisiran once on Day 1

  • Farmaco Inclisiran placebo

    Inclisiran placebo once on Day 1

  • Farmaco QCZ484

    QCZ484 once on Day 1

  • Farmaco QCZ484 placebo

    QCZ484 placebo once on Day 1

Esiti misurati

  1. Esito primario

    Percent change from baseline of PCSK9 levels

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

    Orizzonte temporale Baseline and Month 3

  2. Esito primario

    Percent change from baseline of AGT levels

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

    Orizzonte temporale Baseline and Month 3

  3. Esito secondario

    Change from baseline of systolic blood pressure

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

    Orizzonte temporale Baseline, Month 3 and Month 6

  4. Esito secondario

    Change from baseline of LDL-C levels

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

    Orizzonte temporale Baseline, Month 3 and Month 6

  5. Esito secondario

    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.

    Orizzonte temporale Up to month 12

Date

Data di inizio29 maggio 2026 (effettiva)
Conclusione primaria28 aprile 2027 (stimata)
Conclusione3 febbraio 2028 (stimata)
Prima pubblicazione27 maggio 2026 (effettiva)
Ultimo aggiornamento30 luglio 2026
Risultati pubblicatiNon indicato nella scheda del registro
Stato verificato l'ultima voltaluglio 2026

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

Centri

29 centri stanno reclutando

United States

StrutturaCittàStato o regioneStato
Flourish Medical Clinical TrialsBoca RatonFloridaIn reclutamento
Clinical Research of Brandon LLCBrandonFloridaIn reclutamento
East Coast ResearchCantonGeorgiaIn reclutamento
Great Lakes Clinical TrialsChicagoIllinoisIn reclutamento
ALL Medical Research LLCCooper CityFloridaIn reclutamento
AMR MiamiCoral GablesFloridaIn reclutamento
Universal Axon Clinical ResearchDoralFloridaIn reclutamento
G and L Research LLCFoleyAlabamaIn reclutamento
Anderson Medical ResearchFt. WashingtonMarylandIn reclutamento
Synergy Group Medical LLCHoustonTexasIn reclutamento
Synergy Group Medical LLCHoustonTexasIn reclutamento
East Coast Institute for ResearchJacksonvilleFloridaIn reclutamento
Capitol Cardiology AssociatesLanhamMarylandIn reclutamento
Clinical Trials ResearchLincolnCaliforniaIn reclutamento
Walker Family CareLittle RiverSouth CarolinaIn reclutamento
Downtown L A Research Center IncLos AngelesCaliforniaIn reclutamento
Manassas Clinical Research CenterManassasVirginiaIn reclutamento
Entrust Clinical ResearchMiamiFloridaIn reclutamento
Inpatient Research Clinical LLCMiami LakesFloridaIn reclutamento
Inpatient Research Clinical LLCMiami LakesFloridaIn reclutamento
Monroe Biomedical ResearchMonroeNorth CarolinaIn reclutamento
AMR ChicagoNilesIllinoisIn reclutamento
Valley Clinical TrialsNorthridgeCaliforniaIn reclutamento
American Research Centers of FLPembroke PinesFloridaIn reclutamento
Dominion Medical AssociatesRichmondVirginiaIn reclutamento
East Coast Inst for Research LLCSaint AugustineFloridaIn reclutamento
The Center for Clinical TrialsSaralandAlabamaIn reclutamento
Monroe Research LlcWest MonroeLouisianaIn reclutamento
Alliance for Multispecialty ResearchWichitaKansasIn reclutamento

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

  1. 30 luglio 2026

    Centro aggiunto

    3 sites added (29 total)

    2629

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

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