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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

מגייסמקבל משתתפים כעת, לפי רשומת המרשם.
יצירת קשר עם המחקר

בקצרה

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.

שלב 2דרושים 120 משתתפים29 אתריםמדינה אחת

קטגוריות

לב וכלי דם71%אנדוקריני ומטבולי29%

רשום במרשם אחד

מחקר יחיד יכול להיות רשום בכמה מרשמים. אנו מציגים אותו פעם אחת ומקשרים לכל רשומה שברשותנו.

מידע הניסוי מוצג כפי שפורסם על ידי המרשם, בשפת המקור שלו.

מתעניינים במחקר הזה?

התחברות או צרו חשבון כדי לרשום את התעניינותכם ולעקוב אחר המחקר הזה.

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.

תקציר

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.

מצבים רפואיים

  • Hypercholesterolaemia

זכאות

מיןהכול
גילאים18 Years – 75 Years
מתנדבים בריאיםלא

זכאות כפי שנכתבה במרשם

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

זכאות במשפטים פשוטים

הקריטריונים של רשומה זו טרם פורקו למשפטים נפרדים. טקסט המרשם שלמעלה שלם והוא הגרסה המחייבת.

תכנון המחקר

סוג המחקרהתערבותי
שלבשלב 2
הקצאהאקראי
מודל ההתערבותPARALLEL
מטרה ראשיתTREATMENT
הסתרהDOUBLE (2)
גיוסדרושים 120 משתתפים

נותן חסות ושותפים

  • Novartis Pharmaceuticals נותן חסות

זרועות והתערבויות

  • 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

התערבויות

  • תרופה Inclisiran

    Inclisiran once on Day 1

  • תרופה Inclisiran placebo

    Inclisiran placebo once on Day 1

  • תרופה QCZ484

    QCZ484 once on Day 1

  • תרופה QCZ484 placebo

    QCZ484 placebo once on Day 1

מדדי תוצאה

  1. מדד תוצאה ראשוני

    Percent change from baseline of PCSK9 levels

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

    מסגרת זמן Baseline and Month 3

  2. מדד תוצאה ראשוני

    Percent change from baseline of AGT levels

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

    מסגרת זמן Baseline and Month 3

  3. מדד תוצאה משני

    Change from baseline of systolic blood pressure

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

    מסגרת זמן Baseline, Month 3 and Month 6

  4. מדד תוצאה משני

    Change from baseline of LDL-C levels

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

    מסגרת זמן Baseline, Month 3 and Month 6

  5. מדד תוצאה משני

    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.

    מסגרת זמן Up to month 12

תאריכים

תאריך התחלה29 במאי 2026 (בפועל)
סיום ראשוני28 באפריל 2027 (משוער)
סיום3 בפברואר 2028 (משוער)
פורסם לראשונה27 במאי 2026 (בפועל)
עודכן לאחרונה30 ביולי 2026
התוצאות פורסמולא צוין ברשומת המרשם
המצב אומת לאחרונהיולי 2026

בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.

מיקומים

29 אתרים מגייסים

United States

מתקןעירמדינה או אזורמצב
Flourish Medical Clinical TrialsBoca RatonFloridaמגייס
Clinical Research of Brandon LLCBrandonFloridaמגייס
East Coast ResearchCantonGeorgiaמגייס
Great Lakes Clinical TrialsChicagoIllinoisמגייס
ALL Medical Research LLCCooper CityFloridaמגייס
AMR MiamiCoral GablesFloridaמגייס
Universal Axon Clinical ResearchDoralFloridaמגייס
G and L Research LLCFoleyAlabamaמגייס
Anderson Medical ResearchFt. WashingtonMarylandמגייס
Synergy Group Medical LLCHoustonTexasמגייס
Synergy Group Medical LLCHoustonTexasמגייס
East Coast Institute for ResearchJacksonvilleFloridaמגייס
Capitol Cardiology AssociatesLanhamMarylandמגייס
Clinical Trials ResearchLincolnCaliforniaמגייס
Walker Family CareLittle RiverSouth Carolinaמגייס
Downtown L A Research Center IncLos AngelesCaliforniaמגייס
Manassas Clinical Research CenterManassasVirginiaמגייס
Entrust Clinical ResearchMiamiFloridaמגייס
Inpatient Research Clinical LLCMiami LakesFloridaמגייס
Inpatient Research Clinical LLCMiami LakesFloridaמגייס
Monroe Biomedical ResearchMonroeNorth Carolinaמגייס
AMR ChicagoNilesIllinoisמגייס
Valley Clinical TrialsNorthridgeCaliforniaמגייס
American Research Centers of FLPembroke PinesFloridaמגייס
Dominion Medical AssociatesRichmondVirginiaמגייס
East Coast Inst for Research LLCSaint AugustineFloridaמגייס
The Center for Clinical TrialsSaralandAlabamaמגייס
Monroe Research LlcWest MonroeLouisianaמגייס
Alliance for Multispecialty ResearchWichitaKansasמגייס

מסמכי המחקר

לא צורפו מסמכים ברשומת מרשם זו.

שינויים לאורך זמן

  1. 30 ביולי 2026

    אתר נוסף

    3 sites added (29 total)

    2629

מרשם: ClinicalTrials.gov · NCT########

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