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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

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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 Teilnehmende gesucht29 Studienzentren1 Land

Kategorien

Herz-Kreislauf71%Endokrin und metabolisch29%

In 1 Register registriert

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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.

Zusammenfassung

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.

Erkrankungen

  • Hypercholesterolaemia

Eignung

GeschlechtAlle
Alter18 Years – 75 Years
Gesunde FreiwilligeNein

Eignung im Wortlaut des Registers

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

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

StudientypInterventionell
PhasePhase 2
ZuteilungRandomisiert
InterventionsmodellPARALLEL
Primäres ZielTREATMENT
VerblindungDOUBLE (2)
Teilnahme120 Teilnehmende gesucht

Sponsor und Mitwirkende

  • Novartis Pharmaceuticals Sponsor

Studienarme und Interventionen

  • 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

Interventionen

  • Arzneimittel Inclisiran

    Inclisiran once on Day 1

  • Arzneimittel Inclisiran placebo

    Inclisiran placebo once on Day 1

  • Arzneimittel QCZ484

    QCZ484 once on Day 1

  • Arzneimittel QCZ484 placebo

    QCZ484 placebo once on Day 1

Endpunkte

  1. Primärer Endpunkt

    Percent change from baseline of PCSK9 levels

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

    Zeitrahmen Baseline and Month 3

  2. Primärer Endpunkt

    Percent change from baseline of AGT levels

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

    Zeitrahmen Baseline and Month 3

  3. Sekundärer Endpunkt

    Change from baseline of systolic blood pressure

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

    Zeitrahmen Baseline, Month 3 and Month 6

  4. Sekundärer Endpunkt

    Change from baseline of LDL-C levels

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

    Zeitrahmen Baseline, Month 3 and Month 6

  5. Sekundärer Endpunkt

    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.

    Zeitrahmen Up to month 12

Daten

Startdatum29. Mai 2026 (tatsächlich)
Primärer Abschluss28. April 2027 (geschätzt)
Abschluss3. Februar 2028 (geschätzt)
Erstveröffentlichung27. Mai 2026 (tatsächlich)
Zuletzt aktualisiert30. Juli 2026
Ergebnisse veröffentlichtIm Registereintrag nicht angegeben
Status zuletzt bestätigtJuli 2026

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

29 Studienzentren rekrutieren

United States

EinrichtungStadtBundesland oder RegionStatus
Flourish Medical Clinical TrialsBoca RatonFloridaRekrutiert
Clinical Research of Brandon LLCBrandonFloridaRekrutiert
East Coast ResearchCantonGeorgiaRekrutiert
Great Lakes Clinical TrialsChicagoIllinoisRekrutiert
ALL Medical Research LLCCooper CityFloridaRekrutiert
AMR MiamiCoral GablesFloridaRekrutiert
Universal Axon Clinical ResearchDoralFloridaRekrutiert
G and L Research LLCFoleyAlabamaRekrutiert
Anderson Medical ResearchFt. WashingtonMarylandRekrutiert
Synergy Group Medical LLCHoustonTexasRekrutiert
Synergy Group Medical LLCHoustonTexasRekrutiert
East Coast Institute for ResearchJacksonvilleFloridaRekrutiert
Capitol Cardiology AssociatesLanhamMarylandRekrutiert
Clinical Trials ResearchLincolnCaliforniaRekrutiert
Walker Family CareLittle RiverSouth CarolinaRekrutiert
Downtown L A Research Center IncLos AngelesCaliforniaRekrutiert
Manassas Clinical Research CenterManassasVirginiaRekrutiert
Entrust Clinical ResearchMiamiFloridaRekrutiert
Inpatient Research Clinical LLCMiami LakesFloridaRekrutiert
Inpatient Research Clinical LLCMiami LakesFloridaRekrutiert
Monroe Biomedical ResearchMonroeNorth CarolinaRekrutiert
AMR ChicagoNilesIllinoisRekrutiert
Valley Clinical TrialsNorthridgeCaliforniaRekrutiert
American Research Centers of FLPembroke PinesFloridaRekrutiert
Dominion Medical AssociatesRichmondVirginiaRekrutiert
East Coast Inst for Research LLCSaint AugustineFloridaRekrutiert
The Center for Clinical TrialsSaralandAlabamaRekrutiert
Monroe Research LlcWest MonroeLouisianaRekrutiert
Alliance for Multispecialty ResearchWichitaKansasRekrutiert

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

  1. 30. Juli 2026

    Studienzentrum hinzugefügt

    3 sites added (29 total)

    2629

Register: ClinicalTrials.gov · NCT########

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