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

Last updated: July 9, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

2

Condition

Williams Syndrome

Vascular Diseases

Stress

Treatment

Saline

QCZ484

Clinical Study ID

NCT06857955
CQCZ484A12201
  • Ages 18-75
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 toundergo washout for 4 weeks.

  5. Mean sitting SBP ≥140 mmHg measured by OBPM and mean 24 hr SBP ≥130 mmHg and <160mmHg measured by ABPM.

  6. Participants able to understand and comply with study procedures.

Exclusion

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 AVblock within 6 months prior to screening.

  9. Acute myocardial infarction (AMI) or unstable angina, or any percutaneous coronaryintervention (PCI) or coronary artery bypass graft (CABG) within 12 months prior toscreening. Any history of ischemic or hemorrhagic stroke or transient ischemicattack any time prior to screening.

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Total Participants: 380
Treatment Group(s): 2
Primary Treatment: Saline
Phase: 2
Study Start date:
March 26, 2025
Estimated Completion Date:
April 05, 2028

Study 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.

Connect with a study center

  • Novartis Investigative Site

    Suita, Osaka 565-0853
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Chuo Ku, Tokyo 103-0027
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Chuo ku, Tokyo 104-0031
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Chuo-ku, Tokyo 103-0027
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Shinjuku ku, Tokyo 160-0008
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Singapore, 308433
    Singapore

    Active - Recruiting

  • SEC Clinical Research LLC

    Andalusia, Alabama 36420
    United States

    Active - Recruiting

  • Synexus Clinical Research US Inc

    Tucson, Arizona 85741
    United States

    Active - Recruiting

  • NICRs Research Center

    Garden Grove, California 92844
    United States

    Active - Recruiting

  • Downtown L.A. Research Center Inc

    Los Angeles, California 90017
    United States

    Active - Recruiting

  • Clinical Trials Research Sacramento

    Sacramento, California 95821-2134
    United States

    Active - Recruiting

  • Encompass Clinical Research

    Spring Valley, California 91978-1522
    United States

    Active - Recruiting

  • Clinical Research of Brandon LLC

    Brandon, Florida 33511
    United States

    Active - Recruiting

  • ALL Medical Research LLC

    Cooper City, Florida 33024
    United States

    Active - Recruiting

  • Cen Exel RCA

    Hollywood, Florida 33024
    United States

    Active - Recruiting

  • East Coast Institute for Research

    Jacksonville, Florida 32223
    United States

    Active - Recruiting

  • Entrust Clinical Research

    Miami, Florida 33176
    United States

    Active - Recruiting

  • Inpatient Research Clinical LLC

    Miami Lakes, Florida 33014
    United States

    Active - Recruiting

  • Suncoast Clinical Research

    New Port Richey, Florida 34452
    United States

    Active - Recruiting

  • American Research Centers of FL

    Pembroke Pines, Florida 33027
    United States

    Active - Recruiting

  • Cen Exel FCR

    Tampa, Florida 33613
    United States

    Active - Recruiting

  • Cardiology Partners Clinical Research Institute

    Wellington, Florida 33449
    United States

    Active - Recruiting

  • Centricity Research

    Columbus, Georgia 31904
    United States

    Active - Recruiting

  • Javara Research

    Fayetteville, Georgia 30214
    United States

    Active - Recruiting

  • Solaris Clinical Research

    Meridian, Idaho 83646
    United States

    Active - Recruiting

  • Cedar Crosse Research Ct

    Chicago, Illinois 60607
    United States

    Active - Recruiting

  • Eagle Clinical Research

    Chicago, Illinois 60621
    United States

    Active - Recruiting

  • Synexus Clinical Research US

    Evansville, Indiana 47714
    United States

    Active - Recruiting

  • Alliance for Multispecialty Resrch

    Wichita, Kansas 67207
    United States

    Active - Recruiting

  • Ascension Saint Agnes Heart Care

    Baltimore, Maryland 21229
    United States

    Active - Recruiting

  • Anderson Medical Research

    Fort Washington, Maryland 20744
    United States

    Active - Recruiting

  • Capitol Cardiology Associates

    Lanham, Maryland 20706
    United States

    Active - Recruiting

  • Oakland Medical Research Center

    Troy, Michigan 48085
    United States

    Active - Recruiting

  • Synexus Clinical Research US Inc

    Richfield, Minnesota 55432
    United States

    Active - Recruiting

  • Healthcare Research Network II LLC

    Hazelwood, Missouri 63042
    United States

    Active - Recruiting

  • Jefferson City Medical Group

    Jefferson City, Missouri 65109
    United States

    Active - Recruiting

  • CenExel HRI

    Berlin, New Jersey 08009
    United States

    Active - Recruiting

  • Monroe Biomedical Research

    Monroe, North Carolina 28112
    United States

    Active - Recruiting

  • Burke Primary Care

    Morganton, North Carolina 28655
    United States

    Active - Recruiting

  • Conrad Clinical Research

    Edmond, Oklahoma 73013
    United States

    Active - Recruiting

  • Clinical Neuroscience Solutions Inc

    Memphis, Tennessee 38119
    United States

    Active - Recruiting

  • North Hills Medical Research Inc

    Bedford, Texas 76021
    United States

    Active - Recruiting

  • Synergy Groups Medical LLC

    Missouri City, Texas 77459
    United States

    Active - Recruiting

  • Sun Research Institute

    San Antonio, Texas 78205
    United States

    Active - Recruiting

  • Manassas Clinical Research Center

    Manassas, Virginia 20110
    United States

    Active - Recruiting

  • Dominion Medical Associates

    Richmond, Virginia 23219
    United States

    Active - Recruiting

  • Centricity Research Suffolk Fam Med

    Suffolk, Virginia 23434
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.