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NCT07610278RecruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 30 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
120 (estimated)
First submitted
20 May 2026
Start date
29 May 2026
Primary completion date
28 Apr 2027
Lead sponsor
Novartis Pharmaceuticals
NCT number
NCT07610278

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 120
  • From 29 May 2026 to the primary completion date, 28 Apr 2027
  • 27 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Treatment with certain medications and/or unable to comply with prohibited medications requirements.
    • Other protocol inclusion/exclusion criteria may apply

Other

  • Symptomatic orthostatic hypotension.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (27)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Flourish Medical Clinical Trials
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Boca RatonUnited StatesRecruiting
Clinical Research of Brandon, LLC
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BrandonUnited StatesRecruiting
East Coast Research
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CantonUnited StatesRecruiting
Great Lakes Clinical Trials
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ChicagoUnited StatesRecruiting
ALL Medical Research, LLC
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Cooper CityUnited StatesRecruiting
AMR Miami
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Coral GablesUnited StatesRecruiting
Universal Axon Clinical Research
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DoralUnited StatesRecruiting
G and L Research LLC
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FoleyUnited StatesRecruiting
Anderson Medical Research
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Ft. WashingtonUnited StatesRecruiting
Synergy Group Medical,LLC
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HoustonUnited StatesRecruiting
East Coast Institute for Research
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JacksonvilleUnited StatesRecruiting
Capitol Cardiology Associates
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LanhamUnited StatesRecruiting
Clinical Trials Research
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LincolnUnited StatesRecruiting
Walker Family Care
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Little RiverUnited StatesRecruiting
Downtown L.A. Research Center, Inc.
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Los AngelesUnited StatesRecruiting
Manassas Clinical Research Center
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ManassasUnited StatesRecruiting
Entrust Clinical Research
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MiamiUnited StatesRecruiting
Inpatient Research Clinical LLC
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Miami LakesUnited StatesRecruiting
Monroe Biomedical Research
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MonroeUnited StatesRecruiting
AMR Chicago
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NilesUnited StatesRecruiting
Valley Clinical Trials
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NorthridgeUnited StatesRecruiting
American Research Centers of FL
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Pembroke PinesUnited StatesRecruiting
Dominion Medical Associates
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RichmondUnited StatesRecruiting
East Coast Inst for Research LLC
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Saint AugustineUnited StatesRecruiting
The Center for Clinical Trials
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SaralandUnited StatesRecruiting
Monroe Research, LLC
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West MonroeUnited StatesRecruiting
Alliance for Multispecialty Research
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WichitaUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.