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

May 28, 2026 updated by: Novartis Pharmaceuticals

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

385

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Osaka
      • Suita, Osaka, Japan, 5650853
        • Novartis Investigative Site
    • Tokyo
      • Chuo Ku, Tokyo, Japan, 103-0027
        • Novartis Investigative Site
      • Chuo Ku, Tokyo, Japan, 104-0031
        • Novartis Investigative Site
      • Chuo-ku, Tokyo, Japan, 1030027
        • Novartis Investigative Site
      • Shinjuku Ku, Tokyo, Japan, 160-0008
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 119074
        • Novartis Investigative Site
      • Singapore, Singapore, 529889
        • Novartis Investigative Site
      • Singapore, Singapore, 308433
        • Novartis Investigative Site
      • Singapore, Singapore, 519466
        • Novartis Investigative Site
  • United States
    • Alabama
      • Andalusia, Alabama, United States, 36420
        • SEC Clinical Research LLC
      • Birmingham, Alabama, United States, 35211
        • UAB St Vincents
      • Huntsville, Alabama, United States, 35801
        • Longwood Research
      • Saraland, Alabama, United States, 36571
        • The Center for Clinical Trials
    • Arizona
      • Phoenix, Arizona, United States, 85018
        • Elite Clinical Studies
      • Tucson, Arizona, United States, 85741
        • Synexus Clinical Research US Inc
    • California
      • Garden Grove, California, United States, 92844
        • NICRs Research Center
      • Huntington Park, California, United States, 90255
        • Valiance Clinical Research
      • Los Angeles, California, United States, 90017
        • Downtown L A Research Center Inc
      • Sacramento, California, United States, 95821-2134
        • Clinical Trials Research Sacramento
      • Spring Valley, California, United States, 91978-1522
        • Encompass Clinical Research
    • Florida
      • Brandon, Florida, United States, 33511
        • Clinical Research of Brandon LLC
      • Cooper City, Florida, United States, 33024
        • ALL Medical Research LLC
      • Hialeah, Florida, United States, 33013
        • National Research Institute
      • Hollywood, Florida, United States, 33024
        • Cen Exel RCA
      • Jacksonville, Florida, United States, 32216
        • East Coast Institute for Research
      • Miami, Florida, United States, 33176
        • Entrust Clinical Research
      • Miami Lakes, Florida, United States, 33014
        • Inpatient Research Clinical LLC
      • New Port Richey, Florida, United States, 34452
        • Suncoast Clinical Research
      • Ocala, Florida, United States, 34471
        • Renstar Medical Research
      • Pembroke Pines, Florida, United States, 33027
        • American Research Centers of FL
      • Tampa, Florida, United States, 33613
        • Cen Exel FCR
      • Wellington, Florida, United States, 33449
        • Cardiology Partners Clinical Research Institute
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Centricity Research
      • Fayetteville, Georgia, United States, 30214
        • Javara Research
      • Savannah, Georgia, United States, 31406
        • Velocity Clinical Research
    • Idaho
      • Meridian, Idaho, United States, 83646
        • Solaris Clinical Research
    • Illinois
      • Chicago, Illinois, United States, 60621
        • Eagle Clinical Research
      • Chicago, Illinois, United States, 60607
        • Cedar Crosse Research Ct
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Synexus Clinical Research US
    • Iowa
      • Sioux City, Iowa, United States, 51106
        • Velocity Clin Research Sioux City
    • Kansas
      • Wichita, Kansas, United States, 67207
        • Alliance for Multispecialty Research
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Velocity Clinical Res Baton Rouge
      • Zachary, Louisiana, United States, 70791
        • Southern Clin Research Clinic
    • Maryland
      • Baltimore, Maryland, United States, 21229
        • Ascension Saint Agnes Heart Care
      • Ft. Washington, Maryland, United States, 20744
        • Anderson Medical Research
      • Lanham, Maryland, United States, 20706
        • Capitol Cardiology Associates
    • Michigan
      • Flint, Michigan, United States, 48504
        • AA Medical Research Center
      • Troy, Michigan, United States, 48085
        • Oakland Medical Research Center
      • Ypsilanti, Michigan, United States, 48197
        • Trinity Health Michigan Heart
    • Minnesota
      • Richfield, Minnesota, United States, 55432
        • Synexus Clinical Research US Inc
    • Missouri
      • Hazelwood, Missouri, United States, 63042
        • Healthcare Research Network II LLC
      • Jefferson City, Missouri, United States, 65109
        • Jefferson City Medical Group
      • Kansas City, Missouri, United States, 64111
        • Clin Rsrch Consult a JCCT Company
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Velocity Clin at Pioneer Heart Inst
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • AMR Las Vegas
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • CenExel HRI
    • New York
      • Binghamton, New York, United States, 13905
        • Velocity Clinical Research
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Novant Health Heart Vas Inst
      • Monroe, North Carolina, United States, 28112
        • Monroe Biomedical Research
      • Morganton, North Carolina, United States, 28655
        • Burke Primary Care
      • Rocky Mount, North Carolina, United States, 27804
        • Accellacare of Rocky Mount
      • Salisbury, North Carolina, United States, 28144
        • Accellacare of Salisbury
    • Ohio
      • Columbus, Ohio, United States, 43213
        • CR Services Acquisition US
    • Oklahoma
      • Edmond, Oklahoma, United States, 73013
        • Conrad Clinical Research
    • Oregon
      • Medford, Oregon, United States, 97504
        • Velocity Clinical Research Medford
    • Pennsylvania
      • Linwood, Pennsylvania, United States, 19061
        • TCV Clinical Studies
    • South Carolina
      • Union, South Carolina, United States, 29379
        • Velocity Clinical Research
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Clinical NeuroScience Solutions Inc
    • Texas
      • Austin, Texas, United States, 78759
        • Velocity Clinical Research Austin
      • Bedford, Texas, United States, 76021
        • North Hills Medical Research Inc
      • Houston, Texas, United States, 77061
        • Synergy Group Medical LLC
      • Katy, Texas, United States, 77479
        • Biopharma Informatic
      • Missouri City, Texas, United States, 77459
        • Synergy Groups Medical LLC
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas
      • San Antonio, Texas, United States, 78205
        • Sun Research Institute
    • Utah
      • Layton, Utah, United States, 84041
        • AMR Layton
    • Virginia
      • Manassas, Virginia, United States, 20110
        • Manassas Clinical Research Center
      • Richmond, Virginia, United States, 23219
        • Dominion Medical Associates
      • Suffolk, Virginia, United States, 23435
        • Centricity Research Suffolk Fam Med
    • Washington
      • Puyallup, Washington, United States, 98372
        • MultiCare Ins Research Innovation
      • Spokane, Washington, United States, 99218
        • Velocity Clinical Research Spokane

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

  1. Known history of secondary hypertension.
  2. Orthostatic hypotension.
  3. Laboratory parameter assessments outside of range at screening.
  4. Evidence of hepatic disease.
  5. Medical condition, other than hypertension, requiring treatment with RAAS inhibitor.
  6. Any history of congestive heart failure.
  7. Current or history of intolerance to ACEi and/or ARBs.
  8. Clinically significant cardiac arrhythmias, high-grade AV block and third-degree AV block within 6 months prior to screening.
  9. Acute myocardial infarction (AMI) or unstable angina, or any percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) within 12 months prior to screening. Any history of ischemic or hemorrhagic stroke or transient ischemic attack any time prior to screening.

Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Control
Placebo
Other: Saline
0.9% sodium chloride saline solution
Experimental: QCZ484 Dose 1
QCZ484 Dose 1 solution for injection
Drug: QCZ484
Solution of Injection
Experimental: QCZ484 Dose 2
QCZ484 Dose 2 solution for injection
Drug: QCZ484
Solution of Injection
Experimental: QCZ484 Dose 3
QCZ484 Dose 3 solution for injection
Drug: QCZ484
Solution of Injection
Experimental: QCZ484 Dose 4
QCZ484 Dose 4 solution for injection
Drug: QCZ484
Solution of Injection
Experimental: QCZ484 Dose 5
QCZ484 Dose 5 solution for injection
Drug: QCZ484
Solution of Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Mean 24hr SBP by ABPM
Time Frame: Baseline, Month 3
Change from baseline at Month 3 in mean 24hr systolic blood pressure (SBP) by ambulatory blood pressure measurement (ABPM)
Baseline, Month 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Mean 24hr SBP by ABPM
Time Frame: Baseline, Month 6
Change from baseline at Month 6 in mean 24hr SBP by ABPM
Baseline, Month 6
Change in SBP by OBPM
Time Frame: Baseline, Month 3 and 6
Change from baseline at Month 3 and 6 in SBP by office blood pressure measurement (OBPM)
Baseline, Month 3 and 6
Participants achieving SBP<130 mmHg or SBP reduced by ≥10 mmHg by ABPM
Time Frame: Baseline, Month 3 and 6
Proportion of responders defined as participants achieving SBP<130 mmHg or SBP reduced by ≥10 mmHg from baseline, at Month 3 and 6 by ABPM
Baseline, Month 3 and 6
Change in DBP by ABPM and OBPM
Time Frame: Baseline, Month 3 and 6
Change from baseline at Month 3 and 6 on diastolic blood pressure (DBP) by ABPM and OBPM
Baseline, Month 3 and 6
Number of participants with AEs
Time Frame: Up to Month 18
Number of participants with AEs by treatment group, including changes in vital signs and laboratory results qualifying and reported as AEs.
Up to Month 18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2025

Primary Completion (Estimated)

January 29, 2027

Study Completion (Estimated)

April 5, 2028

Study Registration Dates

First Submitted

March 3, 2025

First Submitted That Met QC Criteria

March 3, 2025

First Posted (Actual)

March 5, 2025

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CQCZ484A12201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Novartis is commited to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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