Recruiting
Phase 2

QCZ484 & Inclisiran

Sponsor:

Novartis Pharmaceuticals

Code:

NCT07610278

Conditions

Hypercholesterolaemia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

QCZ484

Inclisiran

QCZ484 placebo

Inclisiran placebo

Study Details

Brief 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.

Conditions

Hypercholesterolaemia

Study ID

NCT07610278

Start date

May 29, 2026

Status verified date

Jul, 2026

Completion date

Feb 3, 2028

Anticipated

Primary completion date

Apr 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: QCZ484 + Inclisiran

QCZ484 + inclisiran, once on Day 1

active comparator: QCZ484

QCZ484 + inclisiran placebo, once on Day 1

active comparator: Inclisiran

Inclisiran + QCZ484 placebo, once on Day 1

placebo comparator: Placebo

QCZ484 placebo + inclisiran placebo, once on Day 1

Interventions

QCZ484

QCZ484 once on Day 1

Inclisiran

Inclisiran once on Day 1

QCZ484 placebo

QCZ484 placebo once on Day 1

Inclisiran placebo

Inclisiran placebo once on Day 1

Primary outcome measure

  • Percent change from baseline of PCSK9 levels [ Time Frame: Baseline and Month 3 ]
  • Percent change from baseline of AGT levels [ Time Frame: Baseline and Month 3 ]

Central Contacts and Locations

Central contacts

Locations

G and L Research LLC

Recruiting

Foley, Alabama, United States, 36535

Contacts

Christine S Fuller

glresearch5@gmail.com

Principal Investigator:

Nidal Morrar

The Center for Clinical Trials

Recruiting

Saraland, Alabama, United States, 36571

Contacts

Principal Investigator:

Howard Rubenstein

Clinical Trials Research

Recruiting

Lincoln, California, United States, 95648

Contacts

Principal Investigator:

Jeffrey D Wayne

Downtown L A Research Center Inc

Recruiting

Los Angeles, California, United States, 90017

Contacts

Principal Investigator:

Salil U Nadkarni

Valley Clinical Trials

Recruiting

Northridge, California, United States, 91325

Contacts

Principal Investigator:

Mehrdad Ariani

Flourish Medical Clinical Trials

Recruiting

Boca Raton, Florida, United States, 33434

Contacts

Principal Investigator:

Rasha Youssef

Clinical Research of Brandon LLC

Recruiting

Brandon, Florida, United States, 33511

Contacts

Erika Santos

esantos@crofb.com

Principal Investigator:

German Alvarez

ALL Medical Research LLC

Recruiting

Cooper City, Florida, United States, 33024

Contacts

Principal Investigator:

Lorena Lewy-Alterbaum

AMR Miami

Recruiting

Coral Gables, Florida, United States, 33134

Contacts

Principal Investigator:

Abid Chaudhry

Universal Axon Clinical Research

Recruiting

Doral, Florida, United States, 33166

Contacts

Principal Investigator:

Luis Martinez

East Coast Institute for Research

Recruiting

Jacksonville, Florida, United States, 32216

Contacts

Principal Investigator:

Minesh Patel

Entrust Clinical Research

Recruiting

Miami, Florida, United States, 33176

Contacts

Principal Investigator:

Adolfo Cueli

Inpatient Research Clinical LLC

Recruiting

Miami Lakes, Florida, United States, 33014

Contacts

Principal Investigator:

Alexis Gutierrez

Inpatient Research Clinical LLC

Recruiting

Miami Lakes, Florida, United States, 33014

Contacts

Principal Investigator:

Jose Contreras

American Research Centers of FL

Recruiting

Pembroke Pines, Florida, United States, 33027

Contacts

Principal Investigator:

Luis Del Prado Rodriguez

East Coast Inst for Research LLC

Recruiting

Saint Augustine, Florida, United States, 32086

Contacts

Principal Investigator:

Ferris George

East Coast Research

Recruiting

Canton, Georgia, United States, 30114

Contacts

Principal Investigator:

Jason Berner

Great Lakes Clinical Trials

Recruiting

Chicago, Illinois, United States, 60640

Contacts

Principal Investigator:

Manish Jain

AMR Chicago

Recruiting

Niles, Illinois, United States, 60714

Contacts

Principal Investigator:

Manohar Jethani

Alliance for Multispecialty Research

Recruiting

Wichita, Kansas, United States, 67207

Contacts

Principal Investigator:

Jerry Punch

Monroe Research Llc

Recruiting

West Monroe, Louisiana, United States, 71291

Contacts

Principal Investigator:

Assad Mouhaffel

Anderson Medical Research

Recruiting

Ft. Washington, Maryland, United States, 20744

Contacts

Principal Investigator:

Felton Anderson

Capitol Cardiology Associates

Recruiting

Lanham, Maryland, United States, 20706

Contacts

Principal Investigator:

Vineet Venugopal

Monroe Biomedical Research

Recruiting

Monroe, North Carolina, United States, 28112

Contacts

Principal Investigator:

Awawu Igbinadolor

Walker Family Care

Recruiting

Little River, South Carolina, United States, 29566

Contacts

Principal Investigator:

Stephen D Grubb

Synergy Group Medical LLC

Recruiting

Houston, Texas, United States, 77061

Contacts

Principal Investigator:

Deirdre McMullen

Synergy Group Medical LLC

Recruiting

Houston, Texas, United States, 77061

Contacts

Principal Investigator:

Caroline N Mbogua

Manassas Clinical Research Center

Recruiting

Manassas, Virginia, United States, 20110

Contacts

Principal Investigator:

Nabil Andrawis

Dominion Medical Associates

Recruiting

Richmond, Virginia, United States, 23219

Contacts

Principal Investigator:

Richard A Jackson

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Jul 30, 2026

Last verified

Jul, 2026

Keywords

  • Hypertension
  • hypercholesterolemia
  • siRNA
  • inclisiran
  • QCZ484
  • randomized
  • double-blind
  • Phase 2
  • pharmacodynamics
  • AGT
  • PCSK9

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-07-30.