A Study to Identify an Optimal Dose of QCZ484 in Mild to Moderate Hypertensive Patients

Last Update: Dec 04, 2025

A Randomized, Double-blind, Placebo-controlled, Multicenter, 12 Months Treatment Duration, Dose Finding Study, to Evaluate Efficacy, Safety and Pharmacodynamics of QCZ484 in Mild to Moderate Hypertensive Patients

ClinicalTrials.gov Identifier:

NCT06857955

Novartis Reference Number:CQCZ484A12201

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

The purpose of this study is to evaluate the efficacy, safety and tolerability of QCZ484 or placebo, given subcutaneously, every 6 months, at different dose levels in patients with mild to moderate hypertension Phase 2b, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and pharmacodynamics of QCZ484 with mild to moderate hypertension (HTN). Multiple doses of QCZ484 will be tested against placebo, administered as subcutaneous injection.

Condition

Hypertension

Phase

Phase2

Overall Status

Recruiting

Number of Participants

380

Start Date

Mar 26, 2025

Completion Date

Apr 05, 2028

Gender

All

Age(s)

18 Years - 75 Years (Adult, Older Adult)

Interventions

Drug

QCZ484

Solution of Injection

Other

Saline

0.9% sodium chloride saline solution

Eligibility Criteria

Inclusion Criteria:

1. Signed informed consent.
2. Males or females aged 18 to 75 years.
3. Diagnosis of hypertension.
4. Hypertension treatment naive or on maximum 2 anti-HTN medications and able to undergo washout for 4 weeks.
5. Mean sitting SBP ≥140 mmHg measured by OBPM and mean 24 hr SBP ≥130 mmHg and \<160 mmHg measured by ABPM.
6. Participants able to understand and comply with study procedures.

Exclusion Criteria:

A Study to Identify an Optimal Dose of QCZ484 in Mild to Moderate Hypertensive Patients

Study Description

Interventions

QCZ484

Saline

Eligibility Criteria

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

SEC Clinical Research LLC

Donavon Wewers

Erin Tucker

Synexus Clinical Research US Inc

Jacquie Chilberg

Judith Brown

NICRs Research Center

Liliana Gavino

Mallu Reddy

Downtown L.A. Research Center Inc

Daysi Aguilar

Salil Nadkarni

Clinical Trials Research Sacramento

Alan Jazuli

Jeffrey D Wayne

Clinical Research of Brandon LLC

Ariel Concepcion

German Alvarez

ALL Medical Research LLC

Catherine Cruz

Craig Shapiro

Lorena Lewy-Alterbaum

Inpatient Research Clinical LLC

Alexis Gutierrez

Anabel De la Nuez

Entrust Clinical Research

Adolfo Cueli

Lynda Velazquez

American Research Centers of FL

Luis Del Prado Rodriguez

Monica Elso

Cen Exel FCR

Carla Rothacker

Deborah White

Cardiology Partners Clinical Research Institute

Elizabeth Dagher

Jean Foucauld

Javara Research

Frank N Cole

Mary Willams

William Cooper

Solaris Clinical Research

David Butuk

Gina McCluskey

Cedar Crosse Research Ct

Danny Hiroshi Sugimoto

Sanii Terry

Eagle Clinical Research

Esther Ayodele

Olalekan Sowade

Synexus Clinical Research US

Elizabeth Robb

Mohammed Allaw

Ascension Saint Agnes Heart Care

Barbara Klimuszka

Jeffrey Cole

Capitol Cardiology Associates

Melissa Cruz

Vineet Venugopal

Oakland Medical Research Center

Jay Sandberg

Julieanna Sherrod

Synexus Clinical Research US Inc

Melissa Choi

Sidney Noah

Monroe Biomedical Research