Home › Trials › NCT06857955

Finding the best dose of QCZ484 for patients with mild to moderate hypertension

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

Phase 2 Interventional Novartis · NCT06857955

This study is testing different doses of a new medication called QCZ484 to see if it can help people with mild to moderate high blood pressure feel better and stay healthy.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment380 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorNovartis Industry-sponsored
Locations84 sites (Andalusia, Alabama and 83 other locations)
Trial IDNCT06857955 on ClinicalTrials.gov

What this trial studies

This Phase 2b clinical trial aims to evaluate the efficacy, safety, and tolerability of QCZ484, administered subcutaneously every six months, in patients with mild to moderate hypertension. The study is multicenter, randomized, double-blind, and placebo-controlled, comparing multiple doses of QCZ484 against a placebo. Participants will be monitored for their response to the treatment, including pharmacodynamics and overall health outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a diagnosis of mild to moderate hypertension who are either treatment naive or on a maximum of two antihypertensive medications.

Not a fit: Patients with secondary hypertension, significant cardiac conditions, or those requiring treatment with RAAS inhibitors may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for managing mild to moderate hypertension.

How similar studies have performed: Other studies have shown promise in evaluating new antihypertensive treatments, but the specific approach of QCZ484 is novel.

Eligibility criteria

Show full inclusion / exclusion 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:

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

Where this trial is running

Andalusia, Alabama and 83 other locations

+34 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions HypertensionQCZ484
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.