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NCT07610278PHASE2Recruiting

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

Novartis Pharmaceuticals

Start Date

5/29/2026

Completion Date

2/3/2028

Summary

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.

Detailed Description

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.

Eligibility Criteria

Age Range: 18 years to 75 years

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

Interventions

DRUG

QCZ484

DRUG

Inclisiran

DRUG

QCZ484 placebo

DRUG

Inclisiran placebo

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Conditions

Hypercholesterolaemia

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

East Coast Institute for Research

Jacksonville, Florida 32216

United States

Entrust Clinical Research

Miami, Florida 33176

United States

Inpatient Research Clinical LLC

Miami Lakes, Florida 33014

United States

Inpatient Research Clinical LLC

Miami Lakes, Florida 33014

United States

American Research Centers of FL

Pembroke Pines, Florida 33027

United States

East Coast Inst for Research LLC

Saint Augustine, Florida 32086

United States

East Coast Research

Canton, Georgia 30114

United States

Great Lakes Clinical Trials

Chicago, Illinois 60640

United States

AMR Chicago

Niles, Illinois 60714

United States

Alliance for Multispecialty Research

Wichita, Kansas 67207

United States

Monroe Research Llc

West Monroe, Louisiana 71291

United States

Anderson Medical Research

Ft. Washington, Maryland 20744

United States

Capitol Cardiology Associates

Lanham, Maryland 20706

United States

Monroe Biomedical Research

Monroe, North Carolina 28112

United States

Walker Family Care

Little River, South Carolina 29566

United States

Synergy Group Medical LLC

Houston, Texas 77061

United States

Synergy Group Medical LLC

Houston, Texas 77061

United States

Manassas Clinical Research Center

Manassas, Virginia 20110

United States

Dominion Medical Associates

Richmond, Virginia 23219

United States