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

29. juli 2026 opdateret af: Novartis Pharmaceuticals

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

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

120

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

  • Navn: Novartis Pharmaceuticals

Studiesteder

  • Forenede Stater
    • Alabama
      • Foley, Alabama, Forenede Stater, 36535
        • Rekruttering
        • G and L Research LLC
        • Ledende efterforsker:
          • Nidal Morrar
        • Kontakt:
      • Saraland, Alabama, Forenede Stater, 36571
    • California
      • Lincoln, California, Forenede Stater, 95648
        • Rekruttering
        • Clinical Trials Research
        • Ledende efterforsker:
          • Jeffrey D Wayne
        • Kontakt:
      • Los Angeles, California, Forenede Stater, 90017
        • Rekruttering
        • Downtown L A Research Center Inc
        • Kontakt:
        • Ledende efterforsker:
          • Salil U Nadkarni
      • Northridge, California, Forenede Stater, 91325
    • Florida
      • Boca Raton, Florida, Forenede Stater, 33434
        • Rekruttering
        • Flourish Medical Clinical Trials
        • Ledende efterforsker:
          • Rasha Youssef
        • Kontakt:
      • Brandon, Florida, Forenede Stater, 33511
        • Rekruttering
        • Clinical Research of Brandon LLC
        • Ledende efterforsker:
          • German Alvarez
        • Kontakt:
      • Cooper City, Florida, Forenede Stater, 33024
        • Rekruttering
        • ALL Medical Research LLC
        • Ledende efterforsker:
          • Lorena Lewy-Alterbaum
        • Kontakt:
      • Coral Gables, Florida, Forenede Stater, 33134
      • Doral, Florida, Forenede Stater, 33166
      • Jacksonville, Florida, Forenede Stater, 32216
        • Rekruttering
        • East Coast Institute for Research
        • Ledende efterforsker:
          • Minesh Patel
        • Kontakt:
      • Miami, Florida, Forenede Stater, 33176
      • Miami Lakes, Florida, Forenede Stater, 33014
      • Pembroke Pines, Florida, Forenede Stater, 33027
      • Saint Augustine, Florida, Forenede Stater, 32086
        • Rekruttering
        • East Coast Inst for Research LLC
        • Ledende efterforsker:
          • Ferris George
        • Kontakt:
    • Georgia
      • Canton, Georgia, Forenede Stater, 30114
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60640
        • Rekruttering
        • Great Lakes Clinical Trials
        • Ledende efterforsker:
          • Manish Jain
        • Kontakt:
      • Niles, Illinois, Forenede Stater, 60714
        • Rekruttering
        • AMR Chicago
        • Ledende efterforsker:
          • Manohar Jethani
        • Kontakt:
    • Kansas
      • Wichita, Kansas, Forenede Stater, 67207
    • Louisiana
      • West Monroe, Louisiana, Forenede Stater, 71291
    • Maryland
      • Ft. Washington, Maryland, Forenede Stater, 20744
      • Lanham, Maryland, Forenede Stater, 20706
        • Rekruttering
        • Capitol Cardiology Associates
        • Ledende efterforsker:
          • Vineet Venugopal
        • Kontakt:
    • North Carolina
      • Monroe, North Carolina, Forenede Stater, 28112
        • Rekruttering
        • Monroe Biomedical Research
        • Ledende efterforsker:
          • Awawu Igbinadolor
        • Kontakt:
    • South Carolina
      • Little River, South Carolina, Forenede Stater, 29566
        • Rekruttering
        • Walker Family Care
        • Ledende efterforsker:
          • Stephen D Grubb
        • Kontakt:
    • Texas
      • Houston, Texas, Forenede Stater, 77061
        • Rekruttering
        • Synergy Group Medical LLC
        • Ledende efterforsker:
          • Caroline N Mbogua
        • Kontakt:
    • Virginia
      • Manassas, Virginia, Forenede Stater, 20110
        • Rekruttering
        • Manassas Clinical Research Center
        • Ledende efterforsker:
          • Nabil Andrawis
        • Kontakt:
      • Richmond, Virginia, Forenede Stater, 23219
        • Rekruttering
        • Dominion Medical Associates
        • Ledende efterforsker:
          • Richard A Jackson
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: QCZ484 + Inclisiran
QCZ484 + inclisiran, once on Day 1
Medicin: QCZ484
QCZ484 once on Day 1
Medicin: Inclisiran
Inclisiran once on Day 1
Andre navne:
  • KJX839
  • Leqvio
Aktiv komparator: QCZ484
QCZ484 + inclisiran placebo, once on Day 1
Medicin: QCZ484
QCZ484 once on Day 1
Aktiv komparator: Inclisiran
Inclisiran + QCZ484 placebo, once on Day 1
Medicin: Inclisiran
Inclisiran once on Day 1
Andre navne:
  • KJX839
  • Leqvio
Placebo komparator: Placebo
QCZ484 placebo + inclisiran placebo, once on Day 1
Medicin: QCZ484 placebo
QCZ484 placebo once on Day 1
Medicin: Inclisiran placebo
Inclisiran placebo once on Day 1

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percent change from baseline of PCSK9 levels
Tidsramme: Baseline and Month 3
Percent (%) change from baseline of PCSK9 levels for QCZ484 + Inclisiran at Month 3
Baseline and Month 3
Percent change from baseline of AGT levels
Tidsramme: Baseline and Month 3
Percent (%) change from baseline of AGT levels for QCZ484 + Inclisiran at Month 3
Baseline and Month 3

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline of systolic blood pressure
Tidsramme: Baseline, Month 3 and Month 6
Change from baseline of systolic blood pressure for QCZ484 + Inclisiran at Month 3 and 6.
Baseline, Month 3 and Month 6
Change from baseline of LDL-C levels
Tidsramme: Baseline, Month 3 and Month 6
Change from baseline of LDL-C levels for QCZ484 + Inclisiran at Month 3 and 6.
Baseline, Month 3 and Month 6
Number of participants with Treatment-emergent adverse event and abnormal changes in laboratory parameters, vital signs and other safety assessments
Tidsramme: Up to month 12
Number of participants with treatment-emergent adverse event, abnormal changes in laboratory parameters, vital signs and other safety assessments up to Month 12.
Up to month 12

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Novartis Pharmaceuticals

Efterforskere

  • Studieleder: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

29. maj 2026

Primær færdiggørelse (Anslået)

28. april 2027

Studieafslutning (Anslået)

3. februar 2028

Datoer for studieregistrering

Først indsendt

20. maj 2026

Først indsendt, der opfyldte QC-kriterier

20. maj 2026

Først opslået (Faktiske)

27. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CHDY015A12201

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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