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A Study to Evaluate the Pharmacodynamics of a Combination of QCZ484 and Inclisiran 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.

ClinicalTrials.gov IDNCT07610278

PhasePHASE2

Enrollment120

SponsorNovartis Pharmaceuticals

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Hypercholesterolaemia

About this study

Interventions

Drug: QCZ484 — QCZ484 once on Day 1
Drug: Inclisiran — Inclisiran once on Day 1
Drug: QCZ484 placebo — QCZ484 placebo once on Day 1
Drug: Inclisiran placebo — Inclisiran placebo once on Day 1

Primary outcomes

Percent change from baseline of PCSK9 levels (Baseline and Month 3)
Percent change from baseline of AGT levels (Baseline and Month 3)

Eligibility information

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

Study locations

G and L Research LLC, Foley, Alabama 36535 United States
The Center for Clinical Trials, Saraland, Alabama 36571 United States
Clinical Trials Research, Lincoln, California 95648 United States
Downtown L A Research Center Inc, Los Angeles, California 90017 United States
Valley Clinical Trials, Northridge, California 91325 United States
Flourish Medical Clinical Trials, Boca Raton, Florida 33434 United States
Clinical Research of Brandon LLC, Brandon, Florida 33511 United States
ALL Medical Research LLC, Cooper City, Florida 33024 United States
AMR Miami, Coral Gables, Florida 33134 United States
Universal Axon Clinical Research, Doral, Florida 33166 United States

Showing 10 of 29 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.