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Study of QCZ484 and Inclisiran for High Blood Pressure and Cholesterol

This study is looking at a combination of two medications, QCZ484 and Inclisiran, to see how they affect people with high blood pressure (hypertension) and high cholesterol (hypercholesterolemia). Researchers want to understand how these drugs work together and individually, and if they are safe. You might be eligible if you are 18 to 75 years old, have primary hypertension, and your blood pressure is within a specific range. The study will measure changes in certain body chemicals (PCSK9 and AGT levels) after 3 months to see the effects of the treatments. The current recruitment status is unclear.

Study design
This is a randomized, double-blind study involving about 120 participants. This means participants are randomly assigned to receive either the combination of QCZ484 and Inclisiran, QCZ484 alone, Inclisiran alone, or a placebo (an inactive substance), and neither you nor your doctor will know which treatment you are receiving.
What's involved
The study will last up to 12 months, including screening visits, a treatment day, and a safety follow-up period. You will receive your assigned treatment once on Day 1.
Compensation
Not stated in the trial record.
Follow-up
After receiving treatment, participants will enter a safety follow-up period. The primary endpoints (what the study measures) are assessed at Baseline and Month 3.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07610278

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

Recruiting
PHASE2Ages 18–75InterventionalTreatment
Novartis Pharmaceuticals
~120 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:QCZ484InclisiranQCZ484 placeboInclisiran placebo

At a glance

Recruiting sites
29 of 29 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent change from baseline of PCSK9 levels
Measured over Baseline and Month 3
+1 more outcome measured

Conditions

Hypercholesterolaemia

Explore related trials

Familial hypercholesterolemia - heterozygousHypercholesterolemiaHypertension

Where it's being run

29 sites across 12 states
Florida11
California3
Alabama2
Illinois2
Maryland2
Texas2
Virginia2
Georgia1

Study leadership

  • Novartis Pharmaceuticals · STUDY_DIRECTOR · Novartis Pharmaceuticals

Who to contact

Novartis Pharmaceuticals
[email protected]
1-888-669-6682
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
Fasting serum LDL-C ≥70 mg/dL and \<190 mg/dL using Friedewald equation.
Fasting triglyceride \<400 mg/dL.

Exclusion

Symptomatic orthostatic hypotension.
Treatment with certain medications and/or unable to comply with prohibited medications requirements.

What this trial measures

  • Percent change from baseline of PCSK9 levelsBaseline and Month 3

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

  • Percent change from baseline of AGT levelsBaseline and Month 3

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